Can-Fite gains on EU nod to start pivotal trial for psoriasis therapy
Hailshadow
- Israel-based biotech Can-Fite BioPharma (NYSE:CANF) added ~5% in early trading on Monday in reaction to the EU regulatory clearance over the company’s plans to conduct a pivotal study for experimental psoriasis therapy Piclidenoson.
- The double-blind, placebo-controlled trial is designed to evaluate the candidate as a potential treatment for moderate to severe psoriasis in support of a marketing application.
- Can-Fite (CANF) said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive view on the safety of a 3 mg twice daily regimen of Piclidenoson and its plans for a Phase 3 trial.
- “Should this market registration study produce positive results similar to our COMFORT study, we believe Piclidenoson will be well positioned in a very large market which needs more safe and effective oral drug options,” Chief Executive Pnina Fishman remarked.
- In June, Can-Fite (CANF) said its late-stage COMFORT study met the primary endpoint in patients with moderate-to-severe plaque psoriasis.