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Press Release

2024

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:

		Screenig	InclusionJour 0	Day 30	Day 60	Day 90	P value^$D90 vs D0
Group 1 : 100 µg/kg bid	N	6	6	6	6	6
	LOAD Score	21.0±7.8	25.7±8.6	19.2±8.4*	21.0±9.6	21.5±11.3	NS
	VAS score	3.5±1.9	3.8±1.9	3.4±2.6	3.1±2.1	3.1±1.9	NS
Group 2 :500 µg/kg bid	N (patients)	9	9	9	9	9
	LOAD score	21.4±6.8	22.9±7.2	15.7±8.1	15.4±10.0**	14.9±10.7**	P=0.008
	VAS score	4.0±2.2	4.7±2.3	3.1±1.9	2.5±1.7**	2.3±1.9**	P=0.008

^$ 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

Plasma CTX-1(ng/mL)		Jour 0Pré-traitement	Day 30	Day 60	Day 90	P value^$D90 vs D0
Group 1	N (patients)	10	9	10	10
	Dose		25 mg/kg/d	25 mg/kg/d	50 mg/kg/d
	Mean±SD	0,27±0,23	0,06±0,01***	0.08±0,04*	0,10±0,04	P=0,004
Group 2	N (patients)	10	9	9	10
	Dose		50 mg/kg/d	50 mg/kg/d	50 mg/kg/d
	Mean±SD	0,26±0,17	0,09±0,04*	0,09±0,06*	0,09±0,05	P=0,03
Gr1 + Gr 2	N (patients)	20	NA	NA	20
Gr1 + Gr 2	Mean±SD	0,26±0,20	NA	NA	0,10±0,04	P=0,0002

^$ 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

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

Vetbiolix and RaQualia Pharma enter into an agreement to develop pet pharmaceuticals for the treatment of gut motility disorders in pets

Lille, April 6th, 2023 - Nagoya and Loos - RaQualia Pharma Inc. (Headquarters: Nagoya, Aichi, Japan; President & CEO: Hirobumi Takeuchi; “RaQualia Pharma”) and Vetbiolix SAS (Headquarters: Loos, Nord, France; Founder & President: Matthieu Roquette; “Vetbiolix”) have agreed to enter into an option and license agreement (“Agreement”) for RQ-00000010 (“RQ-10”), a 5-HT 4 agonist discovered by RaQualia Pharma, to develop pet pharmaceuticals for the treatment of gut motility disorders in dogs and cats.

5-HT 4 receptor is a protein that responds to the neurotransmitter serotonin and is expressed in various tissues and organs, including the brain and digestive system. In the digestive system, the 5-HT 4 receptor promotes gut motility and regulates the contractions on the stomach and intestines, helping digestion and absorption. 5-HT 4 agonists stimulate the release of acetylcholine, which promotes smooth muscle contraction and enhances gut motility. As a result, the 5-HT 4 agonists are useful in treating gut dysmotility, a condition characterized by abnormal contractions of the muscles in the digestive tract, which can lead to symptoms such as constipation and abdominal pain.

RQ-10 is a potent, highly selective, and orally bioavailable small molecule 5-HT 4 agonist. RaQualia Pharma has conducted various non-clinical studies and a phase I clinical study where positive results in terms of efficacy and safety were obtained.

Under the terms of the Agreement, Vetbiloix is granted an exclusive option for an exclusive, worldwide, and sublicensable license to develop, manufacture and market veterinary medicines containing RQ-10. The exclusive option will be valid for up to twenty-four months, during which Vetbiolix will conduct research activities related to proof-of-concept studies using RQ-10. Upon exercise of the exclusive option, Vetbiolix will pay option fees to RaQualiia, and Vetbiolix will be responsible for future global development. RaQualia Pharma is also eligible to receive milestone payments based on development progress. In addition, if the pet pharmaceuticals containing RQ10 are successfully marketed, Vetbiolix will pay RaQualia the sales royalty based on the product sales or license income received by Vetbiolix.

Hirobumi Takeuchi, President & CEO of RaQualia Pharma, stated: “We are very much delighted to have this licensing opportunity for RQ-10 with Vetbiolix, a company that takes a unique and innovative approach to pet pharmaceutical development. In the non-clinical studies using dogs, RQ-10 promoted gastric and colonic motility at a dose as low as 1 μg/kg and showed a favorable pharmacokinetic and safety profile. We hope RQ-10 will improve the lives of dogs and cats suffering from debilitating gut conditions.”

Matthieu Roquette, Founder & President of Vetbiolix, stated: “We are very satisfied to validate this licensing deal with RaQualia: our scientific and veterinary clinical experts have been rapidly convinced with data generated by RaQualia Pharma on the unique therapeutic potential of RQ-10 to significantly improve the gold standard treatment of gut motility disorders affecting pets. There is a crucial unmet medical need in this therapeutic area whereas demands from the veterinary community and the pets parents is dramatically growing, and we believe RQ-10 has the potential to become a "game changer" gastrointestinal (“GI”) disorder drugs in the GI-Pet Market.”

Through the Agreement, RaQualia Pharma and Vetbiolix will further strengthen their development pipelines and contribute to improving the lives of pets and pet parents by providing new treatment options for gut motility disorders in pets.

About RaQualia Pharma

RaQualia Pharma is a research-based biotech with a research headquarter in Nagoya, Japan, aiming to be a “Global Drug Discovery Innovator”, which utilizes cutting-edge life science technologies to create new medicines focusing on unmet medical needs. RaQualia Pharma’s mission is to develop innovative new drug candidates through an open innovation network, and to deliver valuable new therapeutic drugs to patients through joint research and development or by out-licensing with pharmaceutical companies

For more information, please visit https://www.raqualia.com/

A propos de Vetbiolix – https://www.vetbiolix.com

Vetbiolix develops innovative products for the treatment and prevention of diseases affecting pets. As pharmaceutical and biotech companies research new molecules and compounds for human medicine, testing in different species often reveals exciting possibilities for companion animals. Vetbiolix has developed a unique approach focused on turning this potential into innovative prescription drugs and pet care products. To date, veterinarians still have few therapeutic and preventative care products available to them that have been specifically developed and approved for companion animals. Vetbiolix focuses exclusively on the clinical developments of prescription drugs, diagnostic tests, nutraceuticals and pet care products, thanks to its qualified external R&D partners in Europe and the United States. Vetbiolix is supported by the Eurasanté Bio-Incubator, the health cluster in northern France ranked among the top 20 European incubators promoting the development of pharma / biotech start-ups (Labiotech.eu 2019).

Management:

Matthieu Roquette (https://www.linkedin.com/in/matthieu-roquette-99714643/)
Matthieu Dubruque (https://www.linkedin.com/in/matthieu-dubruque-3372985/)
Dr Rémy Hanf (https://www.linkedin.com/in/r%C3%A9my-hanf-99b13273/)

Scientific and Clinical Advisors:

Dr Mathieu Demoury (https://www.opal-vet.fr/l-equipe)
Dr Valérie Freiche (https://www.linkedin.com/in/val%C3%A9rie-freiche-7b16a742/)

Contact: matthieu.roquette@vetbiolix.com / matthieu.dubruque@vetbiolix.com

Vetbiolix raises €2.5 million in funds and launches the clinical development of its “First-in-class” drug candidates in dogs and cats for periodontal diseases and osteoarthritis

Lille, Thursday September 8th, 2022 - Vetbiolix, a veterinary biotechnology company based in France, labeled French Tech Seed, announces a fundraising of 2.5 million euros. The seed round brings together the two investment funds, CapTech Santé (leader of the round) and Nord France Amorçage (NFA), BPI France, and a pool of Business Angels from the veterinary field who bring high level industrial, scientific and veterinary clinical experience to the company. The new investors join in the capital the founders and Eurasanté, who have supported the project since its creation within the Eurasanté Bioincubator. Vetbiolix has developed an original business model, inspired by the One Health concept, based on exclusive and worldwide operating licenses for drug candidates in human clinical development acquired from international Biotechs. The company targets its acquisitions of drug candidates (i) on mature development programs in humans, and therefore ready to enter the clinic quickly in dog and/or cat patients, and (ii) on diseases for which the physiopathology and the mechanism of action targeted in humans and animals (dogs & cats) are similar. This fundraising allows the company to launch the clinical development of its pipeline of drug candidates, medical devices and innovative care products for dog and cat patients suffering from pathologies whose medical needs are unmet (periodontal diseases, chronic inflammatory diseases, gastrointestinal, dermatological, cancer and related pathologies). During the summer, the company thus validated the launch of its most advanced drug-candidates development programs.:- Clinical Proof of Concept study of a new cathepsin-K inhibitor (First-in-class) in dog patients suffering from periodontal disease,- Tolerance study of a cathepsin-K inhibitor in healthy cats- Clinical Proof of concept study of an A3 adenosine agonist (Frist-in-class) in dog patient suffering from osteoarthritis,- Tolerance study of an A3 adenosine agonist inhibitor in healthy cats Vetbiolix is also continuing to develop prototypes for its internal research programs in Medical Devices (oncology, drug delivery) and Care Products (hair care, ophthalmology, wound healing, weight control).

Matthieu Roquette, Founder, President of Vetbiolix, stated: « We are obviously delighted with this closing, which will allow Vetbiolix to accelerate its clinical developments on its 3 Business Units "Drugs", "Diagnostics" and "Care". Over the past 3 years, the company has built a pipeline of innovative and complementary products, ready to enter clinical development. The exclusive and worldwide licensing agreements for the veterinary market signed by the company with international Human Health Biotechs on drug candidates in clinical development in humans demonstrate the relevance and originality of our value creation model. The “Business-Science-Clinical Vet” partnership of the founding members, all very experienced in their field, was key to the success of these deals. »

Rémy Hanf, PhD, Founder, Chief Scientific Officer of Vetbiolix, added: « Our therapeutic and diagnostic products are, for the most part, first-in-class in clinical development in humans. The licensing-in agreements concluded by the company on the drug candidate products allow us to access packages of human preclinical-clinical-CMC(*) information which are very valuable for clinical development in dogs and/or cat. Our products do not require new preclinical steps: we build our “dog-patient / cat-patient” clinical protocols very quickly in our development process. In addition, on the industrial level, we benefit from the solid work of CMC carried out by our Biotech partners. The R&D work carried out by the company so far is promising and we look forward to obtaining the first results of clinical proof of concept in sick dog and cat patients. »(*) CMC = Chemistry, Manufacturing and Controls Matthieu Dubruque, Founder, Managing Director of Vetbiolix, stated: « With this closing, Vetbiolix takes the train of Vet Biotech pioneers in the world. Our team of Business-Science-Clinical founders is efficient, the operational team has been strengthened and over the past 3 years we have selected the best R&D partners required throughout the value creation chain of our products. The "Proof of concept" clinical trial protocols are being deployed in veterinary clinical investigation sites in Europe: the first efficacy results are expected by the end of 2023 / beginning of 2024. At the same time, we are continuing our scouting process of Human product opportunities to enter into new exclusive worldwide veterinary license agreements in therapeutic areas complementary to those already targeted by the company. »

CapTech Santé and NFA, lead investors, added: « We initiated discussions with Vetbiolix very early in its part incubation process because we consider the therapeutic companion animal market has very significant potential for innovation in the years to come. Moreover, we strongly believe in the originality of Vetbiolix's business model and the density/quality of its pipeline. The founding team has achieved the goals it set for itself over the past 3 years of incubation at Eurasanté by signing valuable licensing agreements with international listed Human Health Biotech companies, proof of the credibility and maturity of the Management Team in place and the relevance of its processes to create value in the near future. »

A propos de Vetbiolix – https://www.vetbiolix.com

Management:

Matthieu Roquette (https://www.linkedin.com/in/matthieu-roquette-99714643/)
Matthieu Dubruque (https://www.linkedin.com/in/matthieu-dubruque-3372985/)
Dr Rémy Hanf (https://www.linkedin.com/in/r%C3%A9my-hanf-99b13273/)

Scientific and Clinical Advisors:

Dr Mathieu Demoury (https://www.opal-vet.fr/l-equipe)
Dr Valérie Freiche (https://www.linkedin.com/in/val%C3%A9rie-freiche-7b16a742/)

Contact: matthieu.roquette@vetbiolix.com / matthieu.dubruque@vetbiolix.com

Can-Fite’s Partner Vetbiolix is Heading into a European Multicentric Clinical Trial with Piclidenoson for the Treatment of Pets’ Osteoarthritis

Lille, 8th December 2022

Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced progress achieved in the development of Piclidenoson for` the treatment of osteoarthritis in dogs by the Company’s veterinary commercialization partner Vetbiolix, which is covering all costs associated with veterinary clinical development. The canine osteoarthritis market is projected to reach $3 billion by 2028.

Vetbiolix completed dose-ranging pharmacokinetic (PK) studies in dogs and determined the optimal efficacy and safety dosage for its upcoming European multicentric clinical study. Piclidenoson was well tolerated, with the PK data proportional to dose. Pre-clinical studies were also conducted showing Piclidenoson has a very favorable safety profile.

Based on these data, Vetbiolix has designed a European Multicentric Clinical study protocol for dogs with osteoarthritis which has been approved by an ethical committee.

There is clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease.

“As Piclidenoson advances into a European Multicentric Clinical study for canine osteoarthritis in 2023, we are hopeful that our lead drug candidate, which has produced very good safety and efficacy results in human autoimmune diseases, will do the same for dogs,” stated Can-Fite CEO Dr. Fishman. “This veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canines, while also potentially contributing near-term revenues. We are very pleased to work productively with the team at Vetbiolix.”

In June 2021, Can-Fite entered an agreement with Vetbiolix, a France-based veterinary biotech company, for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix has the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix is conducting studies and covering all associated costs. If the efficacy study yields positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval.

About Piclidenoson

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.

2021

Can-Fite Enters Projected $3 Billion Veterinary Osteoarthritis Market: Signs Agreement with Vetbiolix for Development of Piclidenoson for Pets

Lille, 28th June 2021

Can-Fite PETACH TIKVA, Israel, June 28th, 2021 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has signed a development and commercialization agreement with Vetbiolix, a France-based veterinary biotech company, for the development of Piclidenoson for the treatment of osteoarthritis in companion animals including dogs and cats.

Vetbiolix will have the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix will conduct proof-of-concept studies and cover all associated costs. If the studies yield positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval for veterinary use.

The canine osteoarthritis market is projected to reach $3billion by 2024. According to Grand View Research, the broader global companion animal health market is estimated at a value of $20 billion in 2021 and is expected to grow to $27 billion by 2028.

Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects, and an injectable disease modifying osteoarthritis drug (DMOAD) that targets the progression of the disease. Piclidenoson, an oral drug that has a favorable safety profile in humans and in animal studies, offers a potentially safe and effective oral treatment for canine osteoarthritis.

https://www.vetbiolix.com/wp-content/uploads/2021/06/2021-06-28_Press-Release_Can_Fite_Vetbiolix.pdf