Can-Fite BioPharma's veterinary partner, Vetbiolix, has announced positive final results from a multicenter clinical study evaluating Piclidenoson for the treatment of osteoarthritis in dogs. The study demonstrated significant improvements in clinical status and pain reduction, marking a potential advancement in veterinary medicine. Vetbiolix has already exercised its option for a full in-license agreement with Can-Fite, projecting substantial revenue for the company.
The study investigated the effects of Piclidenoson administered orally at doses of 100 μg/kg and 500 μg/kg twice daily for 90 days in dogs with osteoarthritis. The primary objective was to assess symptom severity using the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire, focusing on mobility. Secondary objectives included pain assessment via the Visual Analog Scale (VAS) reported by pet parents and Numerical Rating Score (NRS) for lameness and pain, as evaluated by veterinarians.
Key Findings
The study reached both primary and secondary endpoints, revealing a dose and time-dependent inhibitory effect of Piclidenoson on LOAD and VAS scores. A favorable trend was also observed in NRS scores, indicating significant improvement in clinical status and decreased pain, particularly with the 500 μg/kg dose. These results suggest that Piclidenoson could offer a valuable therapeutic option for managing canine osteoarthritis.
Market Opportunity
The canine osteoarthritis market is substantial, projected to reach $3 billion by 2028. Current treatments often include non-steroidal anti-inflammatory drugs (NSAIDs), which primarily address symptoms and carry potential harmful side effects. An injectable disease-modifying osteoarthritis drug (DMOAD) exists but targets disease progression rather than immediate symptom relief. Piclidenoson may fill a critical need for a safe and effective treatment option.
Piclidenoson Mechanism of Action
Piclidenoson is a first-in-class, orally bioavailable A3 adenosine receptor agonist (A3AR). It has demonstrated an excellent safety and efficacy profile in a Phase III clinical study for psoriasis in humans. The drug's mechanism involves inhibiting inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and inducing apoptosis in skin cell keratinocytes involved in the disease's pathology. Its success in treating psoriasis suggests potential benefits for inflammatory conditions like osteoarthritis.
Commercial Agreement
Vetbiolix's decision to exercise its option for a full in-license agreement with Can-Fite includes an upfront payment, milestone payments, and royalties on sales upon regulatory approval. This agreement is projected to generate $325 million in income for Can-Fite over the next 10 years, highlighting the commercial potential of Piclidenoson in the veterinary market.
Expert Commentary
"The final data from the osteoarthritis study are very encouraging, and this veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canine and potentially contribute to near-term revenues," stated Can-Fite VP of Business Development Dr. Sari Fishman. "We are very pleased to work productively with the team at Vetbiolix."
