Positive Outcomes in Osteoarthritis Dog Study with Piclidenoson

Can-Fite BioPharma Ltd., a biotechnology company known for developing small molecule drugs aimed at treating oncological and inflammatory diseases, has announced promising results from a recent multicenter clinical study. The study, conducted by its veterinary partner Vetbiolix, focused on dogs suffering from osteoarthritis and explored the efficacy of the drug Piclidenoson. Vetbiolix has already exercised its option for a full in-license agreement with Can-Fite, which could yield up to $325 million in payments over the next decade, contingent upon regulatory approval and subsequent sales.

The clinical study assessed the impact of administering Piclidenoson at doses of 100 μg/kg and 500 μg/kg twice daily over 90 days. The primary measure of success was based on the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire, which evaluates the severity of symptoms impacting the dogs' mobility. Secondary measures included the Visual Analog Scale (VAS) for pain assessment by pet owners and the Numerical Rating Score (NRS) for evaluating both lameness and pain by veterinarians.

The study successfully met both primary and secondary endpoints, showing that Piclidenoson had a dose- and time-dependent effect on reducing both LOAD and VAS scores. Notably, the 500 μg/kg dose was particularly effective, leading to significant improvements in the clinical condition of the dogs and marked reductions in pain, as indicated by favorable trends in NRS scores.

The market for canine osteoarthritis treatments is anticipated to reach $3 billion by 2028, underscoring a significant need for safe and effective medications. Current treatments typically include oral non-steroidal anti-inflammatory drugs (NSAIDs), which primarily address symptoms and often come with considerable side effects, as well as injectable disease-modifying osteoarthritis drugs (DMOADs) that target disease progression.

Dr. Sari Fishman, Can-Fite’s VP of Business Development, expressed optimism about the study’s outcomes. She highlighted the potential for Piclidenoson to quickly enter the market, improving the well-being of dogs with osteoarthritis and contributing to Can-Fite’s near-term revenue. She also praised the productive collaboration with Vetbiolix.

Piclidenoson is a first-in-class, orally bioavailable A3 adenosine receptor agonist (A3AR) with a strong safety and efficacy profile, as evidenced by a Phase III clinical study in psoriasis. Its mechanism of action includes the inhibition of inflammatory cytokines IL-17 and IL-23, as well as inducing apoptosis in keratinocytes involved in the disease’s pathogenesis.

Can-Fite BioPharma Ltd. is a clinical-stage drug development company working on treatments for cancer, liver diseases, and inflammatory conditions. The company’s lead drug candidate, Piclidenoson, has shown positive topline results in a Phase III trial for psoriasis. Another drug, Namodenoson, is under evaluation in a Phase IIb trial for NASH and a Phase III trial for hepatocellular carcinoma (HCC), with plans for a Phase IIa study in pancreatic cancer. Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for HCC by the FDA. It has also shown potential in treating other cancers, including colon, prostate, and melanoma. The company’s third drug candidate, CF602, has demonstrated efficacy in treating erectile dysfunction. To date, these drugs have been tested in over 1,600 patients, showcasing an excellent safety profile.

Vetbiolix, Can-Fite’s veterinary partner, specializes in developing innovative products for the treatment and prevention of diseases in pets. It boasts a unique pipeline of first-in-class oral small molecules licensed from human biotech sources, addressing unmet veterinary medical needs in periodontitis, osteoarthritis, and gut motility disorders. Vetbiolix focuses exclusively on the clinical development of its drug candidates, investing in proof of concept studies, pharmaceutical developments, and regulatory clinical studies. The company aims to generate revenue through out-licensing and co-development deals with the veterinary pharmaceutical industry.