- Positive interim analysis data was released in October 2020 based on results from 200 patients
- Topline results expected Q1 2022
Can-Fite BioPharma Ltd. (NYSE American: 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™ 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® 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.
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. It is currently being evaluated in a multinational Phase III study as a treatment for moderate to severe psoriasis and a Phase II U.S. study for the treatment of moderate to severe COVID-19.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) 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, inflammatory disease and COVID-19. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH). 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.
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