Can-Fite BioPharma Ltd. announced that its veterinary partner Vetbiolix reported positive final results from the osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite?s veterinary commercialization partner, which is covering all costs associated with veterinary clinical development, successfully concluded the full study. Vetbiolix already exercised its option to enter into a full in-license agreement with Can-Fite and is obligated to pay Can-Fite an upfront payment, milestone payments and royalties on sales upon regulatory approval, summing up to projected income of $325 Million to Can-Fite over the next 10 years.
The study looked at the effect of 90 days treatment with Piclidenoson at 100 µg/kg and 500 µg/kg twice daily orally in dog patients with osteoarthritis. Including all evaluable patients, the primary objective was the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire for the assessment of symptoms severity evaluated on dog?s mobility. The secondary objectives included Visual Analog Scale (VAS) for pain assessment by pet parents and Numerical Rating Score (NRS) for (i) lameness and (ii) pain assessment by the veterinarian.
The study reached the primary and secondary endpoints with a dose and time dependent inhibitory effect of Piclidenoson on LOAD and VAS, together with a favorable trend on NRS scores, demonstrating significant improvement in clinical status and decrease in pain utilizing the 500 µg/kg dose. There is a 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.
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.
