Vetbiolix aims to develop innovative products for treatment and prevention of diseases affecting Pets.

As pharmaceutical and biotech companies research novel molecules and compounds for human medicine, tests in different species often reveal exciting possibilities for pets.  Vetbiolix has developed a unique approach focused on turning this potential into innovative therapeutic solutions for pets. Because, surprisingly, veterinarians have few therapeutics at their disposal that have been specifically developed and approved for pets.

Vetbiolix focus exclusively on clinical development of First-in-class drug-candidates for pets in Periodontitis, Osteoarthritis and Gut Motility Disorders.

Vetbiolix pipeline products is built through:

• Mid and long-term revenues will be generated through out-licensing deals with Big VetPlayers on Drug candidates subsequent to successful pilot and/or pivotal clinical trials withPets.

VBX-1000 – First-in-Class Cathepsin-K Inhibitor (Oral Small Molecule)

• VBX-1000 Program is a potent, selective and reversible cathepsin K inhibitor

• GLP/GCP package up and including human phase I

• In vitro and in vivo efficacy in several animal models and humans.

• Cathepsin K is a key player of bone resorption produced by osteoclasts and tooth resorption by odontoclasts.

• Inhibition of cathepsin K by selective inhibitors decreased bone resorption.

• Inhibition of cathepsin K by selective inhibitors does not impair bone formation (decoupling of boneresorption and bone formation)

• Inhibition of cathepsisn K by selective inhibitors improves bone quality.

• Strong proof of efficacy of selective Cathepsin K inhibitors in clinical trials in human; 50% reduction of fracture risk in post-menauposal women (Phase 3). Significant reduction in bone and cartilage degradation in human patients with knee osteoarthritis (phase 2a – 2020).

• No selective Cathepsin K inhibitor yet approved to date for treating human bone and resorptive tooth diseases

VBX-1000 – Potential future Game Changer for the treatment of Periodontitis

• 80% of dogs and cats over 3 years are suffering from periodontal disease (PD)

• Periodontal disease (PD) is one of the most common inflammatory diseases in dogs. It affects the periodontium, leadingto gingivitis and/or several degrees of periodontitis.

• No therapeutic treatment available to treat bone resorption in Dogs and Cats: only antibiotics to limit microbialsystemic infection risk and NSAIDs to manage inflammation/pain. VETBIOLIX with the VBX-1000 program targets periodontitis and aims to control the bone resorption physiopathological process.

• Only the first stage of the disease is reversible. Inflammation of the gums can be reduced with proper care. Afterthat stage, bone loss becomes a factor, and it can’t be returned to its previous state. But, stopping the bone lossas early as possible will prevent the disease from advancing to its latter stages and more permanent damage.

• Complete/partial tooth removal (dental surgery) is the only option available when the Periodontitis reach advanceddiseased stage (traumatic for both Pets and Pet’ parents, only managed by a limited numbers of Vetenarian and costly / not appropriate for Cats)

• VBX-1000 Program might be a first-in-class  veterinary medicine for Periodontal disease, Osteoarthritis and Osteoporosis

VBX-1000 – Potential veterinary blockbuster product for canine & feline Periodontitis

VBX-2000 – First-in-Class Adenosine A3 Agonist (Oral Small Molecule)

• VBX-2000 is a structure modifying osteoarthritis Drugs

• Activation of A3R inhibits the NFKb pathway and reduces release of major inflammatory mediators: TNFa, IL1b, IL6, IL8…

• Activation of receptor A3R have anti-inflammatory effects in animal models of inflammatory diseases.

• VBX-2000 improves histopathological lesions and pain in a recognized animal model of osteoarthritis (ACLT induced arthritis in rat; Bai et al. 2022;26:4230-4243)

VBX-2000 – Potential future 1st structure modifying Osteoarthritis Drugs for the treatment of Canine & Feline Osteoarthritis.

• 30% of dogs and cats over 1 year are suffering from Osteoarthritis (long list of publications supporting this number)

• Osteoarthritis is a significant cause of pain, lameness and morbidity in dogs and many otherspecies, including humans

• It is a multi-factorial, progressive, degenerative disease of synovial joints, affecting not only the articular cartilage but also other structures within the specific synovial joint (Loeser et al. 2012). Degradation of articular cartilage, subchondral bone sclerosis, osteophytosis, varying degrees of synovitis, meniscal and ligament degeneration are all characteristics of the disease process

• VBX-2000 : first-in-class disease modifier therapeutic agent for the treatment of Canine / Feline Osteoarthritis by (i) preventing cartilage degradation and (ii) reducing inflammation

VBX-2000 – Potential veterinary blockbuster product for canine & feline Osteoarthritis

• Pet OA market Worldwide reached 2,875 Bn€ in 2021

• Forecast Pet OA market (World): 5,520 Bn$ by 2031

VBX-3000 – First-in-Class 5-hT4 Agonist (Oral Small Molecule)

• 5-HT 4 receptors are expressed in the enteric nervous system of GI tract, and are well-known to beassociated with the modulation of GI motility.

• Activation of 5-HT 4 receptors evokes release of neurotransmitters. In this process, acetylcholine(ACh) release is also promoted at the myenteric plexus.

• Increased release of ACh is attributed to increased motor activity in GI tract.

• VBX-3000 (RQ-10) offers a therapeutic potential for the treatment of hypomotility disorders of the upper and lower GI tract.

• VBX-3000 Program is a new generation, highly selective and safe 5-HT 4 receptor partial agonist

• Superior selectivity profile vs others 5-HT4 agonists

• First in human Study in healthy volunteers completed: (i) well tolerated at doses up to 2mg p.o., (ii) enhanced gastric emptying at 3 μg or above and (iii) no densensitization in an accelerated gastric emptying following 8 days treatment was observed

• No safety issues identified in the Human Study : especially no QTc prolongation and other cardiac abnormal changes were seen in VBX-3000 (RQ-10) phase 1 Study,following single and multiple oral administration

• Strong preclinical data generated in Beagle Dog (Tox package for Human Drug Development) confirming (i) VBX-3000 successfully enhanced GI contraction and (ii) VBX-3000 reduce hypomotility induced by Clonidine in Beagle Dogs

VBX-3000 – Potential future 1st new generation prokinetic agent  for the treatment of Canine gastroparesis & Feline coprostasis.

• Prokinetic drugs to restore GI motility are ideal drugs for treating the primary cause of GI dysmotility disorders.

• Today, there is no prokinetic drugs approved for use in companion animals:

• Low doses of erythromycine or prucalopride may be empirically  used off-label

• Agonists of 5HT4 are a prototypical class of prokinetics acting at all levels of GI tract.

• 5-HT4 agonists were human medicines initially approved for treatment of upper GI motility disorders and lower GI motility disorders

• Certain 5-HT4 agonists has been successfully used off-label in dogs and cats suffering from various GI-dysmotility disorders.

• All 5-HT4 agonists initially approved for Human are no longer available after removal  from the Human health market.

• GI-dysmotility disorders in dogs and cats remain important unmet medical needs: VBX 3O00 could become the 1st new prokinetic (5HT4 agonist) for both Gastroparesis in dog and for Chronic Constipation (coprostase) in cat

VBX-3000 – Potential veterinary blockbuster product for canine & feline Gut Motility Disorders

• Pet Gut Motility Disorders market Worldwide reached 0,775 Bn€ in 2021

• Forecast Pet Gut Motility Disorders market (World): 1,520 Bn$ by 2031

Vetbiolix is supported by VC investors CapTech Sante, Nord France Amorçage, Tudigo and BPI France. Furthermore, the Company counts from shareholders Business Angels from the Veterinary Industry.

Vetbiolix also benefits from the constant support and the international Life Science network from Eurasanté Health Cluster / BioFIT event.

2024

Vetbiolix activates the option on the license for RQ-10 (VBX-3000), a 5-HT₄ agonist discovered by RaQualia Pharma, to develop pet pharmaceuticals for the treatment of gut motility disorders in dogs and cats

About Vetbiolix – https://www.vetbiolix.com

Vetbiolix develops innovative products for the treatment and prevention of diseases affecting pets. Vetbiolix has built a unique pipeline of several drug candidates, first in new classes of veterinary medications licensed (exclusive and worldwide license) from Biotechs Santé Humaine worldwide that will address unmet veterinary medical needs in the area of ​​periodontitis, osteoarthritis and intestinal motility disorders. Vetbiolix focuses exclusively on the clinical developments of its drug candidates and invests in (i) proof-of-concept clinical studies, (ii) CMC-Pharmaceutical development, (iii) regulatory clinical pilot studies and (iv) clinical studies. Regulatory pivots. The company’s revenue generation will be based on licensing and/or co-development agreements with the veterinary pharmaceutical industry.

 Contact: matthieu.dubruque@vetbiolix.com

About RaQualia Pharma – https://www.raqualia.com/en/index.html

RaQualia Pharma’s mission is “We brighten people’s lives through the power of innovation.” RaQualia Pharma strives to deliver new medications to those suffering from diseases where no effective treatment options exist or existing treatment methods are insufficient. Guided by this philosophy, RaQualia Pharma is dedicated to the research and development of new medications not only within its own company but also through establishing a next generation drug discovery value chain by strengthening partnerships with academia, start-ups, and venture companies. RaQualia Pharma, as professionals in drug discovery, is focusing on research and development efforts with a primary focus on patients. RaQualia Pharma pursues its science to create innovative, first-in-class therapeutic medications.

Contact: ask@raqualia.com

Vetbiolix completes a Series A fundraising of €4m and launches the European regulatory clinical development of its “First-in-class” drug candidates targeting osteoarthritis and canine and feline periodontitis

Lille, Monday December 02^nd 2024 – Vetbiolix, a veterinary biotechnology company based in France, certified DeepTech France 2030, announces a fundraising of 4 million euros. The Series A round brings together the investment funds, CapTech Santé, Tudigo, Nord France Amorchage as well as management, and BPI France for the non-dilutive part.

This fundraising, which follows the excellent clinical results – known as proof of concept – generated by the company in 2024 on its First-in-class drug candidates VBX-1000 and VBX-2000, allows the company to launch in first quarter 2025 two double-blind randomized versus placebo regulatory pilot studies: the first on owned-dogs suffering from moderate to severe osteoarthritis (Study VBX2400-CL-2001) and the second on owned-dogs suffering from periodontitis (Study VBX1200-CL-2001). The funds raised will also be dedicated to the pharmaceutical development of VBX-1000 and VBX-2000 and to pursue the clinical development of VBX-3000 in intestinal motility disorders in dogs and cats.

Matthieu Roquette, founder and President of Vetbiolix indicates: “We are very satisfied with this closing which exceeds the fundraising objectives that we had set for this Series A. This demonstrates the attractiveness of Vetbiolix which has very innovative drug candidates in its pipeline having demonstrated their effectiveness and safety of use for VBX-1000 and VBX-2000. We are now focused on the production of our next industrial deliverables expected by the veterinary pharmaceutical market and by the community of investors in the sector: in this case the results of our double-blind regulatory clinical studies vs. placebo expected for 2026.”

Matthieu Dubruque, founder and CEO of Vetbiolix, indicates: “With the clinical results generated in 2024 and this fundraising, Vetbiolix is ​​positioning itself as a high-potential Vet Biotech player for the global Top 50 Pharma Vet with the possible perspective of co-developments and /or license transfers of our products by 2026. The same is true with investors targeting animal health. Alongside our efforts dedicated to generating quality clinical data on time, we will be very active in 2025 on Business Development discussions covering the entire spectrum of possible valuation options for Vetbiolix.“

About Vetbiolix – https://www.vetbiolix.com

Vetbiolix develops innovative products for the treatment and prevention of diseases affecting pets. Vetbiolix has built a unique pipeline of several drug candidates, first in new classes of veterinary medications licensed (exclusive and worldwide license) from Biotechs Santé Humaine worldwide that will address unmet veterinary medical needs in the area of ​​periodontitis, osteoarthritis and intestinal motility disorders. Vetbiolix focuses exclusively on the clinical developments of its drug candidates and invests in (i) proof-of-concept clinical studies, (ii) CMC-Pharmaceutical development, (iii) regulatory clinical pilot studies and (iv) clinical studies. Regulatory pivots. The company’s revenue generation will be based on licensing and/or co-development agreements with the veterinary pharmaceutical industry.

 Contact: matthieu.dubruque@vetbiolix.com

Vetbiolix communicates on the final results of the proof-of-concept study of VBX-2000 (piclidenoson) in canine osteoarthritis and on the upcoming submission of a regulatory pilot study vs. placebo

• The main objectives of the VBX2400-CL-1001 proof-of-concept study were achieved at a dose of 500 µg/kg bid:
  • A progressive improvement in the mobility score (LOAD questionnaire) statistically (p<0.01) and clinically significant is obtained after 90 days of treatment at the highest dose tested of 500 µg/kg bid.
  • At this effective dose of 500 µg/kg bid, a progressive reduction in the pain score (VAS) is observed from the first days of treatment, becoming significant after 60 days (p<0.01) and 90 days (<0.001) of treatment.
  • All other secondary efficacy objectives are improved after 90 days of treatment at a dose of 500 µg/kg bid.
  • In the group treated with the low dose of 100 µg/k bid, favorable developments were also obtained without reaching the limit of statistical significance (p>0.05).
  • In both treatment groups, VBX-2000 was very well tolerated throughout the 90 days of treatment.
• Based on the efficacy results obtained in the proof-of-concept study (VBX2400-CL-1001), Vetbiolix is ​​about to launch a new double-blind randomized versus placebo regulatory pilot study (VBX2400-CL-2001) on owned dogs with moderate to severe osteoarthritis (LOAD>10 and <35) at inclusion.

The VBX2400-CL-1001 POC study Proof of Concept clinical study was an open-label, multicenter study (France, Belgium) seeking to evaluate the safety of use and the effects of repeated oral administration of VBX-2000 for 90 days on the mobility and pain of 20 dog patients suffering from osteoarthritis. At inclusion, patients were divided into two treatment groups: group 1 was treated with a dose of 100 µg/kg/bid, group 2 was treated at a dose of 500 µg/kg bid. The primary objective of the study was to evaluate the effects of treatment on the LOAD mobility score (Liverpool-OsteoArthritis-in-Dogs questionnaire), after 90 days of treatment. The secondary objectives of the study focused on the evolution after 90 days of treatment of VAS (Visual Analog Scale) pain scores and NRS (Numerical Rating Score) scores: NRS1 (lameness score) and NRS2 (pain score).

Values are mean±SD

^$ p value D90 vs inclusion visit according to « Wilcoxon matched-pairs signed rank test ». ns: p>0.05

*p<0,05 ; **p<0.01 vs inclusion visit according to « Dunn’s multiple comparisons test »

In both groups, repeated administration of VBX-2000 was well tolerated throughout the trial.

The primary efficacy endpoint was achieved at a dose of 500 µg/kg bid. After 90 days of treatment, the mobility score (LOAD) was significantly improved (p=0.006). This improvement in LOAD was detectable from the first visit on day-30 and became statistically significant after 90 days of treatment (p<0.01). Ultimately, 73% (8/11) of patients presented a clinically significant improvement (ΔLOAD ≤-4 cf Innes JF et al. 2023, PLoS ONE 18(2):e20280912) after 90 days of treatment.

About Vetbiolix – https://www.vetbiolix.com

VETBIOLIX develops innovative products for the treatment and prevention of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs in periodontitis, osteoarthritis and gut motility disorders. VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry.

Vetbiolix communicates interim positive results from the proof-of-concept clinical study of its drug candidate VBX-2000 (piclidenoson; A3R agonist) in dogs suffering from osteoarthritis

• The primary objective of the study has already been achieved. A progressive, dose-dependent improvement in the mobility score (LOAD questionnaire) is observed. At the highest dose tested (500 µg/kg twice daily), this effect on mobility is clinically and statistically significant after 60 days and 90 days of treatment.
• At the same time, a progressive and dose-dependent reduction in the pain score (Visual Analogue Scale; VAS) is obtained. At a dose of 500 µg/kg twice a day (“bid”), the reduction is statistically significant from 60 days of treatment and until the end of the 90-day treatment period.
• At a dose of 500 µg/kg bid after 90 days of treatment, the beneficial effect of repeated administration of VBX-2000 on arthritic pain is confirmed on the NRS2 pain score.

Lille, July 01^st 2024 – Vetbiolix, a veterinary biotechnology company based in France dedicated to the clinical development of First-in-Class drug candidates for the treatment of periodontitis, osteoarthritis and gastric motility disorders in dogs and cats, reports first interim results of the proof-of-concept clinical study of its drug candidate VBX-2000, the first agonist of the adenosine A3 receptor (A3R), for the treatment of osteoarthritis in dogs.

The proof-of-concept clinical study VBX2400-CL-1001 POC study is an open-label, multicenter study (France, Belgium) seeking to evaluate the safety of use and the effects of repeated oral administration of VBX-2000 for 90 days on the mobility and pain of 20 dog patients suffering from osteoarthritis. At inclusion, patients are divided into two groups (objective of 10 patients per group). Group 1 is treated with VBX-2000 at a daily dose of 100 µg/kg bid orally for 90 days. Group 2 is treated with VBX-2000 at a daily dose of 500 µg/kg bid orally for 90 days. The primary objective of the study is to investigate the effects of VBX-2000 on a clinically validated mobility score: the LOAD (Liverpool-OsteoArthritis-in-Dogs questionnaire), after 90 days of treatment. The secondary objectives of the study relate to the evolution after 90 days of treatment of VAS (Visual Analog Scale) pain scores and NRS (Numerical Rating Score) scores measured by the veterinarian: NRS1 (lameness score), NRS2 ( pain score). This interim analysis includes the first 15 dogs included: N=6 in group 1 and N=9 in group 2.

In both groups, repeated administration of VBX-2000 was well tolerated.

The main results are presented in the following table:

^$ p value J90 vs inclusion visit by « Wilcoxon matched-pairs signed rank test ». ns: p>0.05*p<0,05 ; **p<0.01 vs inclusion visit by « Dunn’s multiple comparisons test »

In group 1, the dose of 100 µg/kg bid for 90 days had no significant effect on the mobility score (LOAD) and the pain score (VAS). Conversely, the primary efficacy endpoint is achieved at a dose of 500 µg/kg bid. After 90 days of treatment, mobility was significantly improved (p=0.008). This improvement in LOAD was detectable from the first visit on day-30 and became statistically significant on Day-60 and Day-90. At the same time, at the dose of 500 µg/kg, a progressive reduction in the VAS pain score was observed throughout the treatment period (p=0.008 on Day-90). In both groups, the proportion of patients with a low lameness score (NRS1) increased after 90 days of treatment compared to the proportion before treatment. However, these increases remained non-significant (p>0.05). Likewise, the proportion of patients with a low pain score (NRS2) increased in both groups. This difference compared to the proportion before treatment was statistically significant in the 500 µg/kg bid group (p<0.05).

Rémy Hanf, founder and Chief Scientific Officer of VETBIOLIX – Board member of VETBIOLIX indicates: “The results of this interim analysis of the proof of concept study of our adenosine-A3 receptor agonist drug candidate in dogs suffering from osteoarthritis are extremely exciting. They provide the first proof of clinical effectiveness of a new therapeutic class for better management of osteoarthritis in dogs. Given the clinically significant effects obtained on both mobility and arthritic pain at a dose of 500 µg/kg bid, and without waiting for the full results of the study, we anticipate the implementation of a randomized trial versus placebo, double-blind study in dogs suffering from osteoarthritis at the beginning of 2025.“

Matthieu Dubruque, founder and Managing Director of VETBIOLIX indicates: “These clinical results were eagerly awaited. Due to its very innovative mechanism of action, our molecule targets the cause of osteoarthritis (degradation of cartilage) and its inflammatory consequences. VBX-2000 thus responds to a still unmet medical need, complementing the existing veterinary therapeutic arsenal. This is a new major industrial milestone reached by the company, after our successes already obtained in periodontal disease last April with VBX-1000. For these two products, we are now turning to regulatory clinical development (EMA-FDA) for the potential marketing of VBX-1000 and VBX-2000 by 2028.”

Matthieu Roquette, founder and President of VETBIOLIX indicates: “ With the positive results of this Proof of Concept clinical study, we are pleased to have respected our commitments made to our partner Can-Fite Biopharma, our investors and the veterinarian community. The global market for veterinary drugs treating osteoarthritis targeted by VBX-2000 is estimated at more than $3 billion annually. Finally, the company, with this new success, now has 2 drug candidates (VBX-1000 and VBX-2000) with high potential having demonstrated their safety of use and proof of clinical effectiveness in 2 major veterinary indications. »

About Vetbiolix – https://www.vetbiolix.com

VETBIOLIX develops innovative products for the treatment and prevention of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs in periodontitis, osteoarthritis and gut motility disorders. VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry.

 Contact: matthieu.dubruque@vetbiolix.com

VETBIOLIX announces Positive Results of the Proof-of-Concept Clinical Study of its drug-candidate VBX-1000 in periodontal disease in dogs:

• The primary objective of the study was achieved with a significant reduction (p<0.001) of the plasma marker of bone degradation: CTX1
• A significant reduction (p<0.05) of the alveolar bone defect confirmed by two imaging techniques: Radiography and CBCT (Cone Beam Computed Tomography).
• A significant improvement (p<0.001) in clinical measures of periodontal disease: CAL (Clinical Attachment Loss) and PPD (Periodontal Probing Depth)

Lille (France), April 15^th 2024 – VETBIOLIX, a veterinary biotechnology company dedicated to the clinical development of First-in-Class drug candidates for the treatment of periodontal disease, osteoarthritis and gastric motility disorders in dogs and cats, announces the first positive results of the Proof of Concept Clinical study of its drug-candidate VBX-1000 (as known as MIV-701), the first specific inhibitor of cathepsin-K, for the treatment of periodontal disease in dogs. 

The VBX1200-CL-1001 POC study Proof of Concept (PoC) clinical study was an open, multicenter, European study (France, Poland) seeking to evaluate the safety and efficacy of repeated oral administration of the drug candidate VBX-1000 for 90 days on different parameters of periodontal disease in dogs. This open-label clinical PoC study included a total of 20 dogs suffering from periodontal disease affecting at least three teeth. After scaling and polishing of the teeth, the dog patients were randomly divided into two groups. Group 1 was treated with the product VBX-1000 at a daily dose of 25 mg/kg orally for 60 days. If at the end of this period, the dose of 25 mg/kg/day was well tolerated, a daily dose of 50 mg/kg of VBX-1000 was administered for the following 30 days. Group 2 was treated with VBX-1000 at a daily dose of 50 mg/kg orally for 90 days. The primary objective of the study was to investigate the effects of VBX-1000 on plasma CTX1 concentration after 90 days of treatment. CTX1 comes from bone degradation (resorption) resulting from the activity of Cathepsin-K produced by specialized cells (i.e. osteoclasts). The other objectives of the study focused on the evolution after 90 days of treatment of two essential clinical parameters of periodontal disease measured on a total of 60 teeth (3 teeth/dog; 20 dogs): the CAL (Clinical Attachment Loss) and the PPD (Periodontal Probing Depth). Finally, the evolution of the alveolar bone defect after 90 days was documented on 60 teeth affected by periodontal disease using two distinct imaging techniques: X-ray radiography and CBCT (Cone Beam Computed Tomography). In both groups, repeated administration of VBX-1000 was well tolerated. No deaths and no serious adverse events attributable to treatment were reported. Given the very good tolerance to the dose of 25 mg/kg/day, all dog patients in group 1 received a daily dose of 50 mg/kg during the last 30 days of treatment. The primary efficacy endpoint was met. After 90 days, the plasma concentration of CTX1 in both groups was significantly reduced compared to the value before treatment (see Table 1 below). At the intermediate visits on D30 and D60, the decreases in CTX1 were similar in the two groups. In the entire population (n=20 dogs) the relative decrease after 90 days (D90-D0) was -59% (median value ; 95% CI : -75 ; -45 %). 

Table 1

^$ p value D90 vs D0 according to « Wilcoxon matched-pairs signed rank test ».*p<0,05 ; ***p<0.001 vs D0 according to « Dunn’s multiple comparisons test »

The rapid and continued decrease of CTX1 plasma concentration suggested persistent inhibition of the resorption process that may promotes bone healing around affected teeth. In support of this hypothesis, the comparison of radiographs before and after treatment showed a statistically significant decrease in width (n=60 teeth; 3 teeth/dog; p<0.0001) and depth (n=60 teeth, 3 teeth/dog, p<0.05) of the bone defect existing between the root of the tooth and the maxillary bone. These results were further confirmed in ten dogs (30 teeth) examined by CBCT imaging. Finally, two reference measures used in clinical practice to assess the severity of periodontal disease were significantly improved. On D90, the CAL was reduced on average by 0.99mm compared to D0 (95% confidence interval from -1.27 to -0.70 mm; n=60; p<0.0001). Likewise, the PPD was reduced by 0.98 mm (95% confidence interval from -1.24 to -0.72 mm, n=60, p<0.0001).

Rémy Hanf, Founder and CSO of VETBIOLIX – Board member said: « This first Clinical Proof-of-Concept study of VBX-1000 in periodontal disease in dogs met all our expectations. The results are all in the same direction, suggesting that the oral VBX-1000 product reaches its molecular target, inhibits cathepsin-K activity, promotes alveolar bone healing and regression of periodontal disease. The full results will be detailed in a scientific publication currently being written. Building on the confidence these results give us, we are working with our experts in the field to set up Q4-2024 a regulatory Pilot clinical study seeking to strengthen the demonstration of the effects of VBX-1000 in a double blind, randomized, placebo-controlled clinical trial in dogs. »

Matthieu Dubruque, Founder and Managing Director of VETBIOLIX added: « This is an important milestone for VETBIOLIX and we are of course very satisfied of these first clinical results. Periodontal disease is one of the leading causes of veterinary consultations for dogs and cats. These first results in dog patients support our entrepreneurial model and demonstrate the ability of VETBIOLIX to deliver rewarding clinical results. Likewise, we are expecting the results of clinical proof of concept studies for 4 other programs in our portfolio by the end of 2024: VBX-1100 in periodontal disease in cats, VBX-2400 in osteoarthritis in dogs, VBX-3500 and VBX-3600 in gastrointestinal motility disorders in cats and dogs. »

Matthieu Roquette, Founder and President of VETBIOLIX said: « These very encouraging results reinforce our determination to continue the development of our drug candidate VBX-1000 in periodontal disease in dogs. To lead the next stages of development of VBX-1000 and our products portfolio as a whole, the team must gradually strengthen. The recent arrival of Dr Karine Bertrand as Chief Pharmaceutical and Technical Officer – Board Member in charge of the pharmaceutical development of our products obviously contributes to the confidence we have in achieving our objectives. »

About VETBIOLIX– https://www.vetbiolix.com

VETBIOLIX develops innovative products for the treatment and prevention of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs in periodontitis, osteoarthritis and gut motility disorders. VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry.

Since mid-2022, VETBIOLIX has been conducting multicenter European Proof of Concept clinical studies on dog patients and cat patients with its most advanced drug candidates:

– VBX1000: Proof of Concept clinical studies of a Cathepsin-K inhibitor in dog patients (VBX1200-CL-1001 PoC study) and cat patients (VBX1100-CL-1001 PoC study) suffering from periodontitis

– VBX2000: Proof of Concept clinical study of an Adenosin-A3 agonist in dog patients (VBX2400-CL-1001 PoC study) suffering from osteoarthritis

– VBX3000: Proof of Concept clinical studies of a new generation 5-HT4 agonist in dog (VBX3600-CL-1001 PoC study) and cat patients (VBX3500-CL-1001 PoC study) suffering from gastric motility disorders

 Contact: matthieu.dubruque@vetbiolix.com

Vetbiolix strengthens its Top Management with the arrival of Dr Karine Bertrand as Chief Pharmaceutical & Technical Officer – Board Member

Lille, Friday March 27^th, 2024 – Vetbiolix (LOOS – Parc Eurasanté Lille Métropole), a France-based veterinary biotechnology company dedicated to the clinical development of First-in-Class drug candidates for the treatment of periodontitis, osteoarthritis and gastric motility disorders in dogs and cats, announces the arrival of Dr Karine Bertrand as Chief Pharmaceutical & Technical Officer – Board Member. Karine Bertrand is responsible for the entire CMC (“Chemistry, Manufacturing and Controls”) aspect of the company’s products, and particularly the pharmaceutical development of the company’s 3 flagship programs. Karine Bertrand also joins the VETBIOLIX Strategic Committee alongside the company’s co-founders Matthieu Roquette (President), Matthieu Dubruque (Managing Director), Rémy Hanf (Chief Scientific Officer) and historical VCs shareholders.

Karine Bertrand is a graduate of ESPCI Paris (École Supérieure de Physique et Chimie Industrielles de la Ville de Paris) and holds a doctorate in medicinal and organic chemistry from the University of Lille. Karine began her career at UCB Pharma then successively joined Genfit (Euronext: GNFT) and Da Volterra where she held several strategic positions (Director of Pharmaceutical and Analytical Chemistry and Development, Director of Strategic Planning and Management of Programs, Executive Vice President of Corporate Development and Director of Product Development). With over 25 years of experience in R&D and pharmaceutical project management, she has a wide range of expertise covering the design and operational and technical management of pharmaceutical discovery, development, manufacturing and control programs, as well as as the definition and implementation of regulatory strategies for products until the moment they are marketed as medicines and medical devices. Throughout her career, she was able to negotiate numerous agreements with manufacturers and suppliers of pharmaceutical raw materials from all continents and supervised the manufacturing of several tons of GMP products.

Karine Bertrand, CPTO – Board Member of VETBIOLIX declared: “VETBIOLIX is a young and agile veterinary biotech with a remarkable economic model. This has enabled it to build a unique pipeline of several drug candidates, first in new classes of veterinary medications, and already advanced in terms of pharmaceutical development. I am very happy to join the team and to be able to play a decisive role in the development of these new therapeutic solutions, in particular to invest in the remaining challenges to meet industrial, commercial and regulatory requirements. »

Matthieu Roquette, founder et President of VETBIOLIX said: « We are obviously delighted that Karine has joined us. Its operational and strategic experience in the Drug Development process over the last 25 years will allow VETBIOLIX to significantly accelerate on the “CMC” industrial aspect, fundamental in our discussions with potential future purchasers of our drug candidates within of the global veterinary industry. »

Matthieu Dubruque, founder and Managing Director of VETBIOLIX mentioned: « This is a 5-stars recruitment for the company! We are very proud to have convinced Karine to join us. This demonstrates the coherence and attractiveness of the VETBIOLIX project: the innovation and potential of its pipeline of course, but also the solidity of its shareholder base and the complementarity of its management team “Business-Science-Clinique” and now “CMC-Pharmaceutical Development”. We are now perfectly equipped to meet the challenges of regulatory clinical and pharmaceutical development and move forward effectively with the EMA and the FDA. Welcome Karine ! »

About Vetbiolix – https://www.vetbiolix.com

Vetbiolix develops innovative products for the treatment and prevention of diseases affecting pets. Vetbiolix has built a unique pipeline of First-in-class small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs in periodontitis, osteoarthritis and gut motility disorders. Vetbiolix focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical development, (iii) regulatory clinical Pilot studies and (iv) regulatory clinical Pivotal studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry.

 Since mid-2022, VETBIOLIX has been conducting multicenter European Proof of Concept clinical studies on dog patients and cat patients with its most advanced drug candidates:

– VBX1000: Clinical Proof of Concept studies of a Cathepsin-K inhibitor in dog patients (VBX1200-CL-1001 PoC study) and cat patients (VBX1100-CL-1001 PoC study) suffering from periodontitis

– VBX2000: Clinical Proof of Concept studies of an Adenosin-A3 agonist in dog patients (VBX2400-CL-1001 PoC study) suffering from osteoarthritis

– VBX3000: Clinical Proof of Concept studies of a new generation 5-HT4 agonist in dog (VBX3600-CL-1001 PoC study) and cat patients (VBX3500-CL-1001 PoC study) suffering from gastric motility disorders 

2023