Benzinga | Sep 2, 2021 07:04AM EDT

Can-Fite Reports Completion Of Patient Enrollment In Phase 3 Psoriasis Study; Topline Results Expected In Q1'22

* Positive interim analysis data was released in October 2020 based on results from 200 patients

* Topline results expected Q1 2022

PETACH TIKVA, Israel--(BUSINESS WIRE)-- Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has completed enrollment of all patients (>400) planned for its Phase III Comfort(tm) study in patients with moderate to severe plaque psoriasis.

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Image from prior Phase II clinical trial of Piclidenoson of patient's skin before treatment and at week 12 following treatment (Photo: Business Wire)

Positive interim data analysis from this Phase III study was released by Can-Fite in October 2020. The Independent Data Monitoring Committee (IDMC) conducted a pre-planned interim analysis of 200 patients' data and recommended, based on the positive data, to continue the study. At this point, the Company has completed the enrolment of all patients for this study and plans to release topline results in Q1 2022.

The randomized, double blind, active and placebo controlled study is being conducted in Europe, Israel, and Canada. The study's primary endpoint is the proportion of patients who achieve a PASI score response of ?75% (PASI 75) vs. placebo at week 16. Secondary endpoints include non-inferiority to Otezla(r) in weeks 16 and 32. Patients enrolled in the study have been selected based on their over-expression of the A3 adenosine receptor (A3AR), Can-Fite's therapeutic target.

"Because psoriasis is a chronic condition, it's important for effective treatments to also show good safety and minimal side effects as they are used long term. While injectable biologics have been effective, their potential side effects make them less optimal for long-term use. We believe that based on the positive interim analysis, Piclidenoson, as a small molecule oral drug, shows great potential to demonstrate both efficacy and safety. We look forward to announcing topline results in the first quarter of 2022," stated Can-Fite CEO Dr. Pnina Fishman.

Otezla generated $2.2 billion in sales in 2020. According to iHealthcareAnalyst, the psoriasis therapeutic market is estimated to reach $11.3 billion by 2025. Piclidenoson has been out-licensed for the indication of psoriasis in major markets including Canada, Europe, and Asia with deal terms including potential upcoming milestone payments and double-digit royalties upon regulatory approval.