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Denali Concrete Management (DCMG) Announces Phase 3 Dry Eye Study

Yesterday, Denali Concrete Management, Inc. announced that the company has started patient enrollment for a phase 3 study targeted towards patients with moderate-to-severe Dry Eye Syndrome. The study is being performed to determine the safety and efficiency of CF101, an orally administered drug.

Denali Concrete (as of December 21, known as OpthaliX) is a biopharmaceutical company, focused on developing products for the treatment of opthalmic disorders. Their product CF101 is an A3 adenosine receptor agonist. The drug is currently developed for ophthalmic indications, including Dry Eye Syndrome (Phase 3), 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).

Denali estimates that approximately 47 million people in several markets suffer from Dry Eye Syndrome, which causes eye irritation, blurred/fluctuating vision, as well as more severe symptoms that can cause constant discomfort and potentially culminate in a permanent loss of vision. The phase 3 study of CF101 will be conducted in the U.S., Europe and Israel. The test will be among 231 participants who will, over a course of 24 weeks, be given two doses of CF101 and a placebo; the patients who receive the drug and placebo will be randomized. The end goal of the test is a complete clearing of corneal staining.

Pnina Fishman, the Company’s interim CEO said, “We are very pleased with the initiation of enrollment to the Dry Eye Syndrome phase 3 study. The positive data from the previous phase 2 study as well as the excellent safety profile of CF101 indicates the potential of this innovative oral drug for the treatment of Dry Eye Syndrome.”

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