Can-Fite Reports Positive Results Of Phase II Trial For CF101

Can-Fite BioPharma (Can-Fite) has reported that its 75-patient phase II clinical study with CF101 to treat patients with moderate to severe Psoriasis has successfully met its primary objectives.

Reportedly, the patients in the double-blind study were randomly assigned to1, 2 or 4mg of CF101 or placebo twice daily. The drug was taken orally as a monotherapy for 12 weeks.

By several analyses, the patient group receiving 2mg CF101 has demonstrated significant improvement in Psoriasis Activity and Severity Index (PASI) scores and the primary efficacy endpoint in the trial.

Moreover, the group receiving 2mg twice daily has showed positive improvement in mean PASI score, relative to baseline, after 12 weeks of treatment.

Furthermore, the group’s improvement was significantly superior to the placebo group results. 83% of the 2mg group patients has demonstrated improvement in disease parameters upon CF101 treatment and 35% demonstrated an improvement of over 50% (PASI 50).

CF101 was safe and well tolerated during the study period. The important safety result adds to the drug’s remarkable safety record from past studies in more than 700 patients.

The company said that the success in the study adds up to the success in a recently announced clinical study in dry eye patients. In both these studies the patients were treated with CF101 as a stand-alone treatment. The success in both these studies points to the potential general efficacy of CF101 in treatment of inflammatory diseases.

Michael David, head of the department of dermatology at Rabin Medical Center, and the study principal investigator, said: “CF101 is a unique small molecule orally bioavailable drug with an impressive safety profile based on accumulated experience in more than 700 patients. There is a market need in Psoriasis for small molecule drugs and I am confident that Can-Fite should progress with the clinical development of CF101 based on the study data.”