BioWorld Today - Mimetogen Launches Phase 2 Trial of Topical NGF in Dry Eye

Focusing on ophthalmic diseases with its portfolio of small-molecule nerve growth factor (NGF) mimetic compounds, Mimetogen Pharmaceuticals Inc. is capitalizing on a large, relatively underserved medical market that is growing at about twice the rate of the general pharmaceutical sector: ophthalmology. "Historically, eye diseases have been treated with potions," said Garth Cumberlidge, CEO and co-founder. "It is only in the past 10 years that biotech has begun concentrating on ophthalmic diseases." It is an area of research that a few biotechs and a growing number of pharmas now are entering, he added.

Recent research by Mimetogen co-founder Uri Saragovi, and others indicated that NGF, a naturally occurring protein in the eye, plays a key role in ocular disease and health. The 5-year-old venture-backed company began its first clinical trial in November with lead compound MIM-D3 in dry eye. Mimetogen jumped right into a Phase II study because of excellent safety data in animals, Cumberlidge told BioWorld Today.

The Phase II randomized, double-blind, placebo-controlled multicenter U.S. trial is enrolling 150 patients with moderate-to-severe dry eye syndrome, a condition which may be caused by a number of different conditions and produces discomfort, visual disturbance and potentially can damage the eye surface. The study will test efficacy, tolerability and safety of the drug, administered via eye drops. The study should run until midyear, Cumberlidge said. After the study concludes, the company expects to meet with the FDA, hopefully by the end of this year. Its aim is to out-license or co-develop MIM-D3 after the Phase II trial is completed. MIM-D3 is a small cyclic mimetic of NGF, which is a mucin secretagogue designed to act with specificity to quiet inflammation and restore normal lacrimal gland function. In patients with dry eye, mucin is one of the elements in tears that is deficient. The market for dry eye in the U.S. is about 25 million to 30 million, with equal numbers in Canada and Europe, Cumberlidge said.

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