Can-Fite BioPharma's CF101Phase II/III psoriasis trial fails to meet primary endpoint

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that its Phase II/III psoriasis trial for the Company's drug candidate CF101 did not achieve its primary endpoint.

This Phase II/III double-blind, placebo-controlled study was designed to test the efficacy of CF101 in patients with moderate-to-severe plaque psoriasis. Can-Fite enrolled a total of 326 patients through 17 clinical centers in the U.S., Europe, and Israel. The first study segment was comprised of three arms with 103 patients who received either 1 mg of CF101; 2 mg of CF101; or placebo. All patients receiving placebo were switched to either 1 mg or 2 mg of CF101 after 12 weeks and continued receiving treatment until week 24. Following a positive interim analysis, Can-Fite continued to enroll patients to the second segment of the study. The second study segment was comprised of two arms with 223 patients receiving either 2 mg of CF101 or placebo. All patients receiving placebo were switched to 2 mg of CF101 after 16 weeks and continued receiving treatment until week 32. The primary efficacy endpoint was a statistically significant improvement in the Psoriasis Area Sensitivity Index (PASI) score relative to placebo treatment, and the secondary endpoints were, among others, the Physicians' Global Assessment (PGA) score as well as various safety parameters.

The proportion of patients treated with CF101 who achieved at least a 75% improvement from baseline in disease severity at week 12, as measured by PASI 75 was 8.5% vs. 6.9% in the placebo group. With respect to PGA, 6.4% of patients treated with CF101 achieved clear or almost clear skin at week 12 compared to 3.4% of the placebo patients. CF101 was found to be safe and well tolerated.

"We are disappointed that our trial did not meet its primary endpoint. Regretfully, in the PASI 75 and PGA we did not see any real effect in patients over placebo. We have not yet completed our analysis of secondary endpoint and sub-group analysis and intend to complete it in the near future. Can-Fite is continuing its research and development efforts in relation to its drugs and indications in the pipeline." stated Can-Fite CEO Dr. Pnina Fishman.