Press Release

HomePress Release

Press Releases

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:

Scientific and Clinical Advisors:

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

Read More

2022

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

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:

Scientific and Clinical Advisors:

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

Read More

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

Read more