- The Primary endpoint represents the proportion of patients who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16.
- The Secondary endpoints include non-inferiority to the product Otezla® in weeks 16 and 32.
- The randomized, double-blind, active, and placebo-controlled study is being conducted in Europe, Israel and Canada.
- The enrolled patients in the study have been selected based on their over-expression of the A3AR, Can-Fite’s therapeutic target.
From the CEO of CAn-Fite Biopharma
Dr. Pnina Fishman, CEO of Can-Fite Biopharma, explains, “…While injectable biologics have been effective, their potential side effects make them less optimal for long-term use.
Dr. Fishman added, “As a small molecule oral drug, piclidenoson, shows great potential demonstrating 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.. The psoriasis therapeutics 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.
Can-Fite Biopharma Pipeline
Piclidenoson is the firm’s lead drug candidate for psoriasis and COVID-19. is now in Phase 3trial for psoriasis and Phase 2 for moderate COVID-19.
Namodenoson is heading to a Phase 3 trial for hepatocellular carcinoma (HCC) and is in a Phase 2b trial for the treatment of non-alcoholic steatohepatitis (NASH). This product 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.
Can-Fite BioPharma Ltd. is clinical-stage, with a technology designed to address the markets of cancer, liver disease, inflammatory disease and COVID-19.
For more information please visit www.can-fite.com.
Can-Fite Biopharma Stock
This news is promising but, for some reason or another, it is obvious from the small stock price and Market Cap., investors seem to be unenthusiastic about the firm. We will keep our eyes on it while waiting for the topline results that should be released in Q1 2022.
Read more at www.prohostbiotech.com.
Can-Fite Biopharma Has Encouraging News but Will It Enthuse Investors?
Can-Fite Biopharma Good News
We learned, from Petach Tikva, Israel, that Can-Fite Biopharma (CANF) – a biotechnology company advancing its pipeline of small molecule drugs that address inflammatory, cancer and liver diseases, announced its completion of enrollment of all patients (>400) planned for its Phase 3 Comfort™ study with the firm’s product Piclidenoson in patients with moderate to severe plaque psoriasis.
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug. According to the press release, the favorable therapeutic index of the product was demonstrated in Phase 2 clinical studies. It is currently being evaluated in a multinational Phase 3 study as a treatment for moderate to severe psoriasis and a Phase 2 U.S. study for moderate to severe COVID-19.
Positive Data from the Comfort Study
Positive interim data analysis from this Phase 3 study was released by Can-Fite Biopharma in October 2020. The Independent Data Monitoring Committee (IDMC) recommended, based on positive data, that the firm continues 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.