Positive Results from Osteoarthritis Clinical Study in Dogs Reported by Can-Fite’s Partner Vetbiolix
Can-Fite BioPharma (NYSE American: CANF) announced positive results from a clinical study in dogs with osteoarthritis conducted by its partner Vetbiolix. The study found that Piclidenoson significantly improved clinical status and reduced pain in canine patients. The study, which utilized a 90-day treatment period with doses of 100 μg/kg and 500 μg/kg administered twice daily, met both primary and secondary objectives. The primary objective was assessed using the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire, while secondary objectives included pain assessments through Visual Analog Scale (VAS) and Numerical Rating Score (NRS). The 500 μg/kg dose showed the most significant improvement. Vetbiolix may now enter a full in-license agreement with Can-Fite, including upfront and milestone payments, as well as royalties upon regulatory approval. The canine osteoarthritis market is projected to reach $3 billion by 2028.
- Successful completion of multicenter clinical study for osteoarthritis in dogs.
- Piclidenoson demonstrated significant improvement in clinical status and pain reduction.
- Potential for Vetbiolix to enter a full in-license agreement, offering upfront and milestone payments plus royalties.
- Can-Fite could see near-term revenues from veterinary marketing of Piclidenoson.
- Projected market for canine osteoarthritis drugs to reach $3 billion by 2028, indicating strong market potential.
- No concrete regulatory approval secured yet for Piclidenoson.
Insights
The positive results from the clinical study of Piclidenoson in dogs with osteoarthritis represents a significant development. These findings are noteworthy given the unmet need for effective and safe treatments in the canine osteoarthritis market. Current options, such as NSAIDs, only alleviate symptoms and can have detrimental side effects, while DMOADs target disease progression but aren't always effective. The efficacy of Piclidenoson, particularly at the higher dose, in reducing symptoms and pain is encouraging. This could position Piclidenoson as a frontrunner in a market projected to reach
The study's success in meeting primary and secondary endpoints with a dose and time-dependent response suggests that Piclidenoson could offer a dual benefit of symptom relief and potential disease modification. This aligns with the growing preference for treatments that not only address symptoms but also modify disease progression. It's worth noting that veterinary clinical studies often provide early insights that can be built upon for human applications, hinting at broader implications for Can-Fite's drug pipeline.
Additionally, the collaboration with Vetbiolix covering all costs related to veterinary clinical development indicates a robust partnership, which could accelerate the regulatory pathway and market entry, ultimately benefiting both companies.
From a financial perspective, the potential licensing agreement with Vetbiolix adds a significant revenue stream for Can-Fite. If Vetbiolix exercises its option, Can-Fite stands to gain from upfront and milestone payments, along with royalties on sales following regulatory approval. This could provide
Moreover, the veterinary application of Piclidenoson represents a strategic move to enter the market faster, leveraging the streamlined regulatory process for veterinary drugs compared to human medications. This can bring near-term revenue benefits, which is important for Can-Fite as it continues to advance its pipeline in oncology and inflammatory diseases. With the canine osteoarthritis market projected to grow substantially, capturing even a small market share could translate into significant revenues.
However, investors should also consider the competitive landscape. While Piclidenoson shows promise, its success will depend on market acceptance, pricing strategy and clear differentiation from existing treatments. The financial outlook remains optimistic but contingent on successful market penetration and regulatory approval.
The canine osteoarthritis market is projected to reach
RAMAT GAN,
After Piclidenoson proved efficacious, Vetbiolix can exercise the option to enter into a full in license agreement with Can-Fite and be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval.
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. 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 end points with a dose and time dependent inhibitory effect of piclidenoson on LOAD and VAS and NRS, demonstrating significant improvement in clinical status and decrease in pain in the 500 µg/kg dose.
The canine osteoarthritis market is projected to reach
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.
“We are very much encouraged by the positive results in the osteoarthritis dog clinical study and hope Piclidenoson can be used as an efficacious drug with this unmet clinical indication,” stated Can-Fite CSO Dr. Pnina 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.”
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.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite’s cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the
About VETBIOLIX SAS
VETBIOLIX develops innovative products for the treatment and prevention of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class oral small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs in periodontitis (VBX-1000; Cathepsin-K inhibitor), osteoarthritis (VBX-2000; Adenosin-A3 agonist) and gut motility disorders (VBX-3000; 5-HT4 agonist). VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry.
For more information please visit: https://www.vetbiolix.com
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between
View source version on businesswire.com: https://www.businesswire.com/news/home/20240628278831/en/
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Vetbiolix
matthieu.dubruque@vetbiolix.com
Source: Can-Fite BioPharma Ltd.
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