Can-Fite BioPharma (CANF) said Monday it has initiated a phase 3 study of its Piclidenoson drug candidate in patients with moderate to severe plaque psoriasis, with enrollment starting in Europe and in the US with Canada to follow.
The co-primary objectives of the study are the proportion of patients whose psoriasis is reduced in size and severity by 75% or more and the proportion who achieve a Static Physician's Global Assessment score of either 0 or 1 after 16 weeks, the company said.
The US Food and Drug Administration encouraged the company to enroll adolescent patients due to the strong safety profile of the drug demonstrated during development and earlier trials, Can-Fite said.
Can-Fite is expecting to file a new drug application for Piclidenoson with the FDA and a marketing authorization plan with the European Medicines Agency on the successful conclusion of the trial, the company said.
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