OphthaliX, an advanced clinical-stage biopharmaceutical company focused on developing therapeutic products for the treatment of ophthalmic disorders, has completed preclinical studies which shows that CF101 drug candidate is efficacious in treating anterior uveitis. The pre-clinical study data demonstrated that CF101 is efficacious in preventing the clinical manifestations of anterior uveitis in a well-established animal model.

The current study data together with the previous published results showing the efficacy of CF101 in preventing posterior uveitis, strongly support the utilization of CF101 as a drug candidate for the treatment of patients with Anterior or posterior uveitis and as such address a larger market than either alone. This market exceeds 200,000 patients and therefore CF101 does not fall in the FDA definition of an orphan drug for the uveitis clinical application.

Prof. Pnina Fishman, interim CEO and chairman of OphthaliX commented, “We are very pleased with the successful preclinical study which provides additional proof for the efficacy of CF101 in uveitis and paves the way for a larger patient population to be treated with the drug upon successful clinical development. This will also be reflected in a larger potential market for CF101. We are currently conducting all the preparatory work for a phase II study in uveitis in addition to the ongoing studies in Dry Eye Syndrome and Glaucoma. Although anterior uveitis is most often treated with topical medication, the excellent safety profile of CF101 suggests it could have a very favourable therapeutic index as a novel oral therapy in this disease.”

CF101, an A3 adenosine receptor agonist, is a novel, first in class, small molecule, orally bioavailable drug with a proven efficacy in phase II clinical studies and an excellent safety profile. CF101 is currently developed for ophthalmic indications. including dry eye syndrome (phase III), glaucoma (phase 2) and uveitis. CF101 is also developed for the treatment of autoimmune inflammatory diseases including rheumatoid arthritis (Phase 2b) and psoriasis (phase 2/3).

Uveitis is inflammation of the uvea, the middle layer of the eye that can result in blindness. Anterior uveitis refers to inflammation of the iris alone (iritis) or the iris and ciliary body. Posterior uveitis is inflammation in the retina and/or choroid. Uveitis is estimated as the fifth or sixth leading cause of blindness in the United States.