Clinical trial shows promising results for canine osteoarthritis treatment
Piclidenoson, an orally administered drug, has demonstrated a safety and efficacy profile in a Phase III trial for psoriasis
Photo: Pixel-Shot/Adobe Stock
Can-Fite BioPharma Ltd, a clinical-stage biopharmaceutical company, recently announced that its veterinary collaborator, Vetbiolix, has achieved encouraging final results from a multicenter clinical trial on Piclidenoson for dogs with osteoarthritis. Vetbiolix—a developer of preventive and treatment products for diseases that affect pets—has successfully concluded the study, according to a news release.1
Piclidenoson is an innovative small molecule and the first of its type, acting as an A3 adenosine receptor agonist (A3AR). This drug, which can be taken orally, has shown a strong safety and efficacy profile in a Phase III trial for psoriasis. It works by inhibiting the inflammatory cytokines interleukin 17 (IL-17) and interleukin 23 (IL-23) and inducing apoptosis in skin cell keratinocytes that play a role in the disease's pathology.
The study aimed to investigate the effects of 90 days of treatment with Piclidenoson. Canine patients with arthritis received an oral dose of 100 μg/kg and 500 μg/kg of Piclidenoson twice a day for 90 days. According to Can-Fite, the primary objective was to assess the severity of dogs’ symptoms using the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire, which focused on the dogs' mobility.
Secondary objectives included the Visual Analog Scale (VAS) for pain assessment reported by pet owners, and the Numerical Rating Score (NRS) for evaluating lameness and pain as assessed by veterinarians.
The study met its primary and secondary endpoints, demonstrating a dose and time dependent inhibitory effect on LOAD and VAS from Piclidenoson, according to Can-Fite. There was also a favorable trend in NRS scores, which showed improvements in clinical condition and pain reduction with the 500 µg/kg dosage.1
“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,” Sari Fishman, PhD, vice president of business development at Can-Fite Biopharma, said in the news release.1 “We are very pleased to work productively with the team at Vetbiolix.”
According to Can-Fite, Vetbiolix has decided to move forward with a comprehensive in-license agreement with Can-Fite, which includes obligations to make an upfront payment, milestone payments, and provide royalties on sales after gaining regulatory approval. This arrangement is projected to generate $325 million for Can-Fite over the next 10 years. Vetbiolix funded all expenses linked to the veterinary clinical development.
Treatments available for canine osteoarthritis currently involve oral non-steroidal anti-inflammatory drugs (NSAIDs), which only target symptoms and can lead to serious adverse effects, according to Can-Fite. There is also an injectable, disease-modifying osteoarthritis drug (DMOAD), capable of slowing down the disease’s progression.1
Reference
Significant positive results from osteoarthritis clinical study in dogs treated with piclidenoson. Can-Fite Biopharma Ltd. News release. October 18, 2024. Accessed October 18, 2024. https://www.globenewswire.com/en/news-release/2024/10/18/2965580/0/en/Significant-Positive-Results-from-Osteoarthritis-Clinical-Study-in-Dogs-Treated-with-Piclidenoson.html
