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 favorable data from further analysis of its Phase II/III double-blind, placebo-controlled study designed to test the efficacy of CF101 in patients with moderate-to-severe plaque psoriasis.
The study included 326 patients through 17 clinical centers in the U.S., Europe, and Israel with a duration of 32 weeks where the primary endpoint was after 12 weeks. On March 30, 2015, Can-Fite announced the study did not meet its primary endpoint of a statistically significant improvement in the Psoriasis Area Severity Index (PASI) 75 score relative to placebo after 12 weeks of treatment. However, based on further analysis of the efficacy and safety results from the study as described below, Can-Fite intends to continue the development of CF101 for the treatment of psoriasis and has initiated work on the design of the next advanced–stage clinical trial protocol.
Further analysis of the entire study period revealed that by 32 weeks of treatment with CF101, 33% of the patients achieved PASI 75 while the mean percent of improvement in PASI score was 57% (p<0.001) . This was a statistically significant cumulative and linear improvement during weeks 16 to 32.
Most significantly, by week 32 of the study, 20% of the study patients reached PASI 90, a result demonstrating a response rate of 90% clearing of skin lesions. PASI 90 is one of the most stringent and difficult to meet clinical endpoints for measuring responses to psoriasis treatments. Moreover, the PASI 90 subset analysis further suggests a higher and significant (p=0.026) CF101 response rate of 27% among patients previously untreated with systemic psoriasis therapy compared to patients pre-treated with systemic drugs. The Company believes this presents the opportunity that CF101 can be developed as a first-line systemic therapy for patients with moderate-severe psoriasis and for patients who do not want to be treated with the current systemic drugs due to safety issues. Currently there is no universally accepted first-line systemic therapy for patients diagnosed with psoriasis, and therefore CF101, an orally bioavailable drug with an excellent safety profile can be positioned for this unmet need.
"The cumulative and linear improvement in CF101's efficacy treating moderate to severe psoriasis over a longer period of time is a very significant finding for Can-Fite and the psoriasis treatment market. Based on the very favorable safety data on CF101 from this and other trials, coupled with its oral administration, we believe CF101 offers a valuable potential treatment solution for psoriasis and we are committed to continuing our development program," stated Can-Fite CEO Dr. Pnina Fishman. "We are particularly encouraged by the new data that show CF101 could serve as a first-line therapy for moderate-severe psoriasis based on the higher efficacy in patients who were previously not treated with systemic therapy."
Cardiovascular disease pathways associated with psoriasis, but not other immune-mediated diseases