Israel-based biotechnology company Can-Fite BioPharma’s subsidiary OphthaliX has reported top-line results of Phase II clinical trial of CF101 to treat glaucoma.
CF101 is A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug.
The randomised, double-masked, placebo-controlled, parallel-group Phase II trial is intended to determine the safety and efficacy of CF101 when it is administered orally twice daily for up to 16 weeks in patients with elevated intraocular pressure (IOP).
The study involved 89 patients and was conducted with two cohorts.
In the first cohort, the patients were randomised in a 3:1 ratio and were treated with 1mg CF101 to placebo.
In the second cohort, the patients were randomised in a 3:1 ratio and administered with CF101 to placebo ratio, the CF101 dose was increased to 2mg.
The primary endpoint of the trial was not met as it exhibited no significant difference between the group treated with CF101 and the placebo group.
Can Fite BioPharma CEO Pnina Fishman said: “We are disappointed that CF101 failed to meet its primary endpoint, and based on these overall results we see no immediate path forward in glaucoma.”
The Phase II clinical studies have displayed a favourable therapeutic index of CF101.
CF101 is currently being developed to treat autoimmune inflammatory diseases including rheumatoid arthritis (completed Phase II) and psoriasis (completed Phase II/III).