Can-Fite Initiates Pivotal Phase 3 Psoriasis Study of its Oral Drug Piclidenoson with FDA & EMA-Approved Protocol
Can-Fite BioPharma (NYSE: CANF) has initiated a pivotal Phase 3 study for its oral drug Piclidenoson in treating moderate to severe plaque psoriasis, following protocol approval from both FDA and EMA. The study will begin enrolling patients in Europe, with US and Canada expected to follow.
The randomized, double-blind, placebo-controlled trial will evaluate 3mg twice daily oral Piclidenoson tablets versus placebo. The co-primary efficacy objectives include achieving a PASI 75 score and a Static Physician's Global Assessment of 0 or 1 at Week 16.
The FDA has requested two Phase 3 safety and efficacy studies and encouraged including adolescent patients due to the drug's strong safety profile. The company aims to submit a New Drug Application to the FDA and Marketing Authorization Plan to the EMA upon positive study conclusion. The psoriasis market is projected to reach $30 Billion by 2030, with a significant shift toward oral medications.
Can-Fite BioPharma (NYSE: CANF) ha avviato uno studio di fase 3 cruciale per il suo farmaco orale Piclidenoson nel trattamento della psoriasi placca da moderata a grave, dopo l'approvazione del protocollo da parte della FDA e dell'EMA. Lo studio inizierà a reclutare pazienti in Europa, con gli Stati Uniti e il Canada previsti a seguire.
Il trial randomizzato, in doppio cieco e controllato con placebo valuterà compresse orali di Piclidenoson da 3mg assunte due volte al giorno rispetto al placebo. Gli obiettivi di efficacia co-primari includono il raggiungimento di un punteggio PASI 75 e una Valutazione Globale Statica del Medico di 0 o 1 alla Settimana 16.
La FDA ha richiesto due studi di sicurezza ed efficacia di fase 3 e ha incoraggiato l'inclusione di pazienti adolescenti a causa del forte profilo di sicurezza del farmaco. L'azienda mira a presentare una Domanda di Nuovo Farmaco alla FDA e un Piano di Autorizzazione alla Commercializzazione all'EMA al termine dello studio con esito positivo. Il mercato della psoriasi è previsto raggiungere i 30 miliardi di dollari entro il 2030, con un significativo spostamento verso i farmaci orali.
Can-Fite BioPharma (NYSE: CANF) ha iniciado un estudio pivotal de fase 3 para su medicamento oral Piclidenoson en el tratamiento de la psoriasis en placas de moderada a grave, tras la aprobación del protocolo por parte de la FDA y la EMA. El estudio comenzará a reclutar pacientes en Europa, con Estados Unidos y Canadá esperados para seguir.
El ensayo aleatorizado, doble ciego y controlado con placebo evaluará tabletas orales de Piclidenoson de 3 mg administradas dos veces al día frente al placebo. Los objetivos de eficacia co-principales incluyen alcanzar una puntuación PASI 75 y una Evaluación Global Estática del Médico de 0 o 1 en la Semana 16.
La FDA ha solicitado dos estudios de seguridad y eficacia de fase 3 y ha alentado a incluir pacientes adolescentes debido al fuerte perfil de seguridad del medicamento. La empresa tiene como objetivo presentar una Solicitud de Nuevo Medicamento a la FDA y un Plan de Autorización de Comercialización a la EMA al concluir el estudio de manera positiva. Se proyecta que el mercado de la psoriasis alcanzará los 30 mil millones de dólares para el 2030, con un cambio significativo hacia los medicamentos orales.
Can-Fite BioPharma (NYSE: CANF)는 FDA와 EMA의 프로토콜 승인을 받은 후 중등도에서 중증의 판상 건선 치료를 위한 경구 약물 Piclidenoson의 중요한 3상 연구를 시작했습니다. 이 연구는 유럽에서 환자를 모집하기 시작하며, 미국과 캐나다도 이어질 것으로 예상됩니다.
무작위 이중 맹검 위약 대조 시험은 하루 두 번 3mg의 Piclidenoson 경구 정제를 위약과 비교하여 평가할 것입니다. 공동 주요 효능 목표에는 16주차에 PASI 75 점수 달성과 의사의 정적 글로벌 평가에서 0 또는 1을 달성하는 것이 포함됩니다.
FDA는 두 개의 3상 안전성 및 효능 연구를 요청했으며, 약물의 강력한 안전성 프로파일로 인해 청소년 환자의 포함을 권장했습니다. 회사는 긍정적인 연구 결과에 따라 FDA에 새로운 약물 신청서를 제출하고 EMA에 마케팅 승인 계획을 제출하는 것을 목표로 하고 있습니다. 건선 시장은 2030년까지 300억 달러에 이를 것으로 예상되며, 경구 약물로의 상당한 전환이 있을 것입니다.
Can-Fite BioPharma (NYSE: CANF) a lancé une étude pivotale de phase 3 pour son médicament oral Piclidenoson dans le traitement de la psoriasis en plaques modérée à sévère, suite à l'approbation du protocole par la FDA et l'EMA. L'étude commencera à recruter des patients en Europe, avec les États-Unis et le Canada qui devraient suivre.
Le essai randomisé, en double aveugle et contrôlé par placebo évaluera des comprimés oraux de Piclidenoson de 3 mg pris deux fois par jour par rapport au placebo. Les objectifs d'efficacité co-primaires incluent l'atteinte d'un score PASI 75 et une évaluation globale statique du médecin de 0 ou 1 à la semaine 16.
La FDA a demandé deux études de sécurité et d'efficacité de phase 3 et a encouragé l'inclusion de patients adolescents en raison du fort profil de sécurité du médicament. L'entreprise vise à soumettre une demande de nouveau médicament à la FDA et un plan d'autorisation de mise sur le marché à l'EMA à l'issue d'une conclusion positive de l'étude. Le marché de la psoriasis devrait atteindre 30 milliards de dollars d'ici 2030, avec un changement significatif vers les médicaments oraux.
Can-Fite BioPharma (NYSE: CANF) hat eine entscheidende Phase-3-Studie für sein orales Medikament Piclidenoson zur Behandlung von moderater bis schwerer Plaque-Psoriasis eingeleitet, nachdem das Protokoll von der FDA und der EMA genehmigt wurde. Die Studie wird mit der Rekrutierung von Patienten in Europa beginnen, wobei die USA und Kanada folgen sollen.
Die randomisierte, doppelblinde, placebokontrollierte Studie wird 3 mg Piclidenoson-Tabletten, die zweimal täglich oral eingenommen werden, gegen Placebo bewerten. Die co-primären Wirksamkeitsziele umfassen das Erreichen eines PASI-75-Scores und einer statischen globalen Bewertung des Arztes von 0 oder 1 in Woche 16.
Die FDA hat zwei Phase-3-Sicherheits- und Wirksamkeitsstudien angefordert und die Einbeziehung von jugendlichen Patienten aufgrund des starken Sicherheitsprofils des Medikaments empfohlen. Das Unternehmen plant, nach positivem Studienabschluss einen Antrag auf Zulassung eines neuen Arzneimittels bei der FDA und einen Plan zur Marktzulassung bei der EMA einzureichen. Der Markt für Psoriasis wird bis 2030 voraussichtlich 30 Milliarden Dollar erreichen, wobei ein signifikanter Trend zu oralen Medikamenten zu verzeichnen ist.
- FDA and EMA approved the Phase 3 trial protocol
- FDA encouraged inclusion of adolescent patients due to strong safety profile
- Drug targets $30 billion market opportunity by 2030
- Oral administration provides competitive advantage in market shifting to oral drugs
- Dual regulatory pathway (FDA & EMA) increases market potential
- Two Phase 3 studies required by FDA, increasing development costs and time
- Efficacy results not expected until Week 16
- Competition in large psoriasis market with established treatments
Insights
Can-Fite's advancement of Piclidenoson to pivotal Phase 3 testing represents a significant milestone in the company's development pipeline. Securing both FDA and EMA approval for the study protocol demonstrates regulatory alignment across major markets and reduces future approval risks.
The psoriasis indication targets a substantial commercial opportunity, with the market projected to reach
The FDA's encouragement to include adolescent patients signals confidence in Piclidenoson's safety profile, potentially expanding the addressable market. The established efficacy endpoints (PASI 75 and sPGA 0/1) are industry-standard, suggesting a well-designed regulatory pathway.
However, investors should note the considerable financial implications for this
Despite these challenges, advancing to pivotal trials signals confidence in Piclidenoson's potential and represents clear progress toward commercialization in a valuable therapeutic space.
The psoriasis market is estimated at
Ramat Gan, Israel, March 24, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that it initiated a pivotal phase 3 psoriasis study of its oral drug Piclidenoson with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) - approved clinical study protocol. The study will enroll patients with moderate to severe plaque psoriasis. Patient enrolment will be initiated in Europe and US and Canada expected to follow.
The study is a randomized, double-blind, placebo-controlled Phase 3 aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis. Patients will be treated with 3 mg twice daily orally Piclidenoson tablets or placebo. The co-primary efficacy objectives of this study are the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥
“We are excited to initiate the Phase 3 study and we believe that Piclidenoson’s oral dosage and excellent safety record, together with its progressive effectiveness over time, make it an ideal drug for the chronic treatment of psoriasis,” stated Can-Fite CEO Motti Farbstein.
Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA.
About Piclidenoson
Piclidenoson is a novel, robust anti-inflammatory first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II and Phase III clinical studies. 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 reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in 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: https://www.canfite.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
+972-3-9241114
FAQ
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