Can-Fite BioPharma Establishes Phase 3 Study for Psoriasis Treatment
The psoriasis market is expected to reach a staggering $30 billion by the next decade, with a substantial shift toward oral medications. In this evolving landscape, Can-Fite BioPharma Ltd. takes a major step forward by announcing the launch of their pivotal Phase 3 study for the innovative oral drug, Piclidenoson. This significant move comes in collaboration with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), employing an approved clinical study protocol.
Overview of the Phase 3 Study
The study will focus on patients suffering from moderate to severe plaque psoriasis, a condition that affects millions globally. Enrolment is set to commence primarily in Europe, with plans to include patients from the U.S. and Canada shortly thereafter. The Phase 3 trial is crafted as a randomized, double-blind, placebo-controlled investigation. Its primary aim is to validate the clinical safety and effectiveness of Piclidenoson as a treatment option for those battling this chronic condition.
Study Objectives and Patient Safety
In this study, participants will receive either 3 mg of Piclidenoson orally twice daily or a placebo. The co-primary objectives are intriguing; they aim to evaluate the percentage of subjects achieving a 75% improvement in their Psoriasis Area and Severity Index (PASI 75) score, alongside those reaching a score of 0 or 1 on the Static Physician's Global Assessment at the 16-week mark. Critically, the FDA has suggested the inclusion of adolescent patients in the trial owing to the encouraging safety profile demonstrated in prior studies.
CEO Remarks and Future Plans
Motti Farbstein, Can-Fite's CEO, expressed enthusiasm about the study's initiation, believing that Piclidenoson's oral administration and established safety history, coupled with its progressive effectiveness, position it as an exceptional choice for long-term psoriasis management. With high expectations, Can-Fite aims to file a New Drug Application (NDA) with the U.S. FDA and a Marketing Authorization Application (MAA) with the EMA contingent upon a favorable outcome from the Phase 3 assessment.
Introducing Piclidenoson
Piclidenoson is a pioneering treatment, classified as an A3 adenosine receptor agonist—a first in its category characterized by its oral bioavailability and a robust safety record, confirmed through Phase II and Phase III clinical trials. The drug operates by inhibiting inflammatory cytokines interleukin 17 and 23, which are notorious for contributing to the pathogenesis of psoriasis. Additionally, it prompts the apoptosis of keratinocytes affected by the disease, showcasing its dual action against inflammation and cellular proliferation.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. stands out as a forward-thinking biotechnology firm committed to developing effective therapies for major health challenges. With its headquarters in Ramat Gan, the company's strategic focus encompasses multiple high-value markets including oncology, liver diseases, and inflammatory conditions. Apart from Piclidenoson, Can-Fite's pipeline showcases promising candidates such as Namodenoson, currently in various stages of trials for different cancer types, and CF602, aimed at erectile dysfunction treatment. Each candidate emphasizes a commendable safety profile, evidenced through extensive patient trials. For further information, visit their official website at Can-Fite BioPharma.
Frequently Asked Questions
What is Piclidenoson?
Piclidenoson is an innovative oral drug designed to treat moderate to severe plaque psoriasis through its anti-inflammatory properties.
What are the primary goals of the Phase 3 study?
The study aims to assess the safety and efficacy of Piclidenoson, focusing on achieving significant improvements in psoriasis severity scores among participants.
How will patient enrollment be conducted?
Patients will initially be recruited across Europe, followed by additional enrollment in the U.S. and Canada.
What safety profile does Piclidenoson have?
Piclidenoson has demonstrated an excellent safety profile in previous trials, which has led to the FDA encouraging inclusion of adolescent patients in the study.
What are Can-Fite's future plans after the trial?
If results of the Phase 3 study are positive, Can-Fite intends to submit a New Drug Application to the FDA and a Marketing Authorization Application to the EMA.
