Can-Fite reports positive analysis of phase 2/3 psoriasis study

Can-Fite BioPharma has announced positive data from a further analysis of its phase 2/3 study to test the efficacy of CF101 in patients with moderate-to-severe plaque psoriasis.

CF101, an A3 adenosine receptor agonist, is a novel, first-in-class, small-molecule, orally bioavailable drug currently in development for the treatment of autoimmune diseases, including psoriasis and rheumatoid arthritis, according to a company press release.

The 32-week phase 2/3 study included 362 patients at 17 clinical centers in the United States, Europe and Israel, with a primary endpoint of statistically significant improvement of Psoriasis Area and Severity Index (PASI) 75 score relative to placebo after 12 weeks treatment.

Can-Fite announced in March that the study did not meet its primary endpoint; however, the Israel-based biotechnology company intends to continue development of CF101 based on further analysis of the efficacy and safety results from the study, according to the release.

At 32 weeks of treatment, 33% of patients achieved PASI 75, with a mean percent of improvement score of 57%, displaying a statistically significant cumulative and linear improvement between weeks 16 and 32, the release stated. Additionally, 20% of patients reached PASI 90 by week 32 of treatment.

PASI subset analysis showed a CF101 response rate of 27% in patients previously untreated with systemic psoriasis therapy compared with patients pretreated with systemic drugs, according to the release.

“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 programs,” Pnina Fishman, PhD, Can-Fite CEO, said in the release.

Reference: ir.canfite.com.