
Can-Fite BioPharma (NYSE American:CANF) announced that it has initiated a pivotal Phase 3 study of its oral drug Piclidenoson for the treatment of psoriasis, with FDA- and EMA-approved protocol.
According to Can-Fite, the study will enroll patients with moderate to severe plaque psoriasis. Patient enrolment will be initiated in Europe with the U.S. and Canada expected to follow. Patients will be treated with 3mg twice-daily oral Piclidenoson tablets or placebo. Upon positive conclusion, Can-Fite anticipates submitting a new drug application to the FDA and a marketing authorization plan to the EMA.
Motti Farbstein, CEO of Can-Fite, commented, “We are excited to initiate the Phase 3 study and we believe that Piclidenoson’s oral dosage and excellent safety record, together with its progressive effectiveness over time, make it an ideal drug for the chronic treatment of psoriasis.”