Significant Positive Results from Osteoarthritis Clinical Study in Dogs Treated with Piclidenoson
Can-Fite BioPharma (NYSE American: CANF) announced positive final results from a multicenter clinical study on dogs with osteoarthritis treated with Piclidenoson. The study, conducted by Can-Fite's veterinary partner Vetbiolix, met its primary and secondary endpoints, showing significant improvement in clinical status and pain reduction at the 500 µg/kg dose.
Vetbiolix has already exercised its option for a full license deal worth $325 million to Can-Fite over the next 10 years. The canine osteoarthritis market is projected to reach $3 billion by 2028. The study results demonstrate Piclidenoson's potential as a safe and effective treatment for canine osteoarthritis, addressing a clear market need.
Can-Fite BioPharma (NYSE American: CANF) ha annunciato risultati finali positivi da uno studio clinico multicentro su cani affetti da osteoartrite trattati con Piclidenoson. Lo studio, condotto dal partner veterinario di Can-Fite, Vetbiolix, ha raggiunto i suoi obiettivi primari e secondari, mostrando un miglioramento significativo nello stato clinico e una riduzione del dolore alla dose di 500 µg/kg.
Vetbiolix ha già esercitato la sua opzione per un accordo di licenza completo del valore di 325 milioni di dollari per Can-Fite nei prossimi 10 anni. Si prevede che il mercato dell'osteoartrite canina raggiunga 3 miliardi di dollari entro il 2028. I risultati dello studio dimostrano il potenziale del Piclidenoson come trattamento sicuro ed efficace per l'osteoartrite canina, soddisfacendo una chiara esigenza di mercato.
Can-Fite BioPharma (NYSE American: CANF) anunció resultados finales positivos de un estudio clínico multicéntrico en perros con osteoartritis tratados con Piclidenoson. El estudio, llevado a cabo por el socio veterinario de Can-Fite, Vetbiolix, cumplió con sus objetivos principales y secundarios, mostrando una mejora significativa en el estado clínico y reducción del dolor con la dosis de 500 µg/kg.
Vetbiolix ya ha ejercido su opción para un acuerdo de licencia completo por un valor de 325 millones de dólares para Can-Fite durante los próximos 10 años. Se proyecta que el mercado de la osteoartritis canina alcanzará 3 mil millones de dólares para 2028. Los resultados del estudio demuestran el potencial de Piclidenoson como un tratamiento seguro y efectivo para la osteoartritis canina, abordando una clara necesidad del mercado.
Can-Fite BioPharma (NYSE American: CANF)은 Piclidenoson으로 치료받은 골관절염 개에 대한 다기관 임상 연구의 긍정적인 최종 결과를 발표했습니다. Can-Fite의 수의학 파트너인 Vetbiolix가 수행한 이 연구는 주요 및 보조 목표를 모두 달성했으며, 500 µg/kg 용량에서 임상 상태의 유의미한 개선과 통증 감소를 보여주었습니다.
Vetbiolix는 향후 10년 동안 Can-Fite에 3억 2500만 달러의 가치가 있는 전체 라이센스 계약 옵션을 이미 실행했습니다. 개 골관절염 시장은 2028년까지 30억 달러에 이를 것으로 예상됩니다. 연구 결과는 Piclidenoson이 개 골관절염에 대한 안전하고 효과적인 치료제로서의 잠재력을 보여주며, 명확한 시장 수요를 충족합니다.
Can-Fite BioPharma (NYSE American: CANF) a annoncé des résultats finaux positifs d'une étude clinique multicentrique sur des chiens atteints d'arthrose traités avec Piclidenoson. L'étude, réalisée par le partenaire vétérinaire de Can-Fite, Vetbiolix, a atteint ses objectifs primaires et secondaires, montrant une amélioration significative de l'état clinique et une réduction de la douleur avec une dose de 500 µg/kg.
Vetbiolix a déjà exercé son option pour un contrat de licence complet d'une valeur de 325 millions de dollars pour Can-Fite au cours des 10 prochaines années. On prévoit que le marché de l'arthrose canine atteindra 3 milliards de dollars d'ici 2028. Les résultats de l'étude démontrent le potentiel de Piclidenoson en tant que traitement sûr et efficace pour l'arthrose canine, répondant à un besoin clair du marché.
Can-Fite BioPharma (NYSE American: CANF) hat positive Endergebnisse aus einer multizentrischen klinischen Studie an Hunden mit Osteoarthritis veröffentlicht, die mit Piclidenoson behandelt wurden. Die Studie, die von Can-Fites veterinärmedizinischem Partner Vetbiolix durchgeführt wurde, erfüllte ihre primären und sekundären Endpunkte und zeigte eine signifikante Verbesserung des klinischen Status und eine Schmerzreduktion bei einer Dosis von 500 µg/kg.
Vetbiolix hat bereits seine Option für einen vollständigen Lizenzvertrag im Wert von 325 Millionen Dollar für Can-Fite in den nächsten 10 Jahren ausgeübt. Der Markt für canine Osteoarthritis wird voraussichtlich bis 2028 3 Milliarden Dollar erreichen. Die Studienergebnisse zeigen das Potenzial von Piclidenoson als sichere und wirksame Behandlung der canine Osteoarthritis und decken einen klaren Marktbedarf ab.
- Positive final results from osteoarthritis clinical study in dogs treated with Piclidenoson
- Vetbiolix exercised option for full license deal worth $325M to Can-Fite over 10 years
- Study met primary and secondary endpoints, showing significant improvement in clinical status and pain reduction
- Potential for near-term revenues from veterinary market
- Canine osteoarthritis market projected to reach $3 billion by 2028
- None.
Insights
The positive results from Can-Fite's canine osteoarthritis study are highly significant for the company's future prospects. With Vetbiolix already exercising its option for a full license deal worth
The study's success in meeting both primary and secondary endpoints demonstrates Piclidenoson's efficacy in improving clinical status and reducing pain in dogs. This positions the drug as a potential game-changer in a market currently dominated by NSAIDs with harmful side effects.
For investors, this news represents a substantial value driver. The projected
The results of this canine osteoarthritis study are groundbreaking for veterinary medicine. Piclidenoson's demonstrated efficacy, particularly at the 500 μg/kg dose, offers a promising alternative to current treatments. The drug's oral administration twice daily is a significant advantage over injectable DMOADs, potentially improving compliance and ease of use for pet owners.
The study's use of well-established assessment tools like LOAD, VAS and NRS lends credibility to the results. The dose-dependent and time-dependent effects observed suggest a robust therapeutic profile. If approved, Piclidenoson could address the urgent need for safer, more effective osteoarthritis treatments in veterinary care, potentially improving the quality of life for millions of dogs suffering from this condition.
Data Reported by Can-Fite Veterinary Partner Vetbiolix who already exercised its option for a full license deal worth
Ramat Gan, Israel, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today 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
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.
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.
“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. We are very pleased to work productively with the team at Vetbiolix.” stated Can-Fite VP of business Development Dr. Sari Fishman.
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. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of NASH a Phase III 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 U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.
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
Contact: matthieu.dubruque@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 Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
FAQ
What were the results of Can-Fite's Piclidenoson clinical study for canine osteoarthritis?
How much is the licensing deal between Can-Fite (CANF) and Vetbiolix worth?
What is the projected size of the canine osteoarthritis market by 2028?
How does Piclidenoson compare to current treatments for canine osteoarthritis?
