Phase III COMFORT study data for CF 101 in psoriasis presented at European Academy of Dermatology and Venerology (EADV) Congress

Can-Fite previously reported the COMFORT study met its primary endpoint with CF 101 (piclidenoson) showing a statistically significant improvement over placebo in psoriasis patients. Piclidenoson is advancing into a pivotal Phase III psoriasis registration trial. The protocol, which is being designed by Dr. Papp, will be submitted to the FDA and the EMA for market clearance of piclidenoson in the treatment of moderate to severe psoriasis.

The COMFORT Phase III study met its primary endpoint of superiority vs. placebo at 16 weeks, p=0.037. Patients treated with piclidenoson showed an improving progressive response over time, and as psoriasis is a chronic disease that may require long-term treatment, this is an important finding. Piclidenoson demonstrated an excellent safety profile, overlapping that of the placebo-treated group. Piclidenoson had a significantly better tolerability profile than Otezla, as GI-related adverse events were 1% for piclidenoson vs. 6% for Otezla, nervous system disorders were 0.7% for piclidenoson, 9.9% for Otezla and 3.3% for the placebo. The discontinuation rate was significantly higher for Otezla vs. piclidenoson. In the secondary endpoint of achieving a PASI 75 response (representing a 75% reduction in psoriasis severity) at week 32, in the whole patient population, Piclidenoson was inferior to Otezla; however, in a sub-group analysis of patients who had PASI greater than 25 (more severe psoriasis) at baseline, piclidenoson had a comparable response to Otezla. In the secondary endpoint of achieving psoriasis disability index (PDI) response at week 32, piclidenoson was comparable to Otezla.