Amakem Begins Dose-Ranging Study For Glaucoma Drug
Clinical stage ophthalmology company Amakem Therapeutics announced the initiation of the Phase II dose-ranging study of its lead drug candidate AMA0076 for glaucoma.
AMA0076 is a locally acting Rho Kinase (ROCK) inhibitor designed to reduce intraocular pressure (IOP) by targeting the main outflow system of the eye while working to minimize side effects, such as hyperemia. Also known as red eye, hyperemia is a troubling side effect that often leads to patient non-compliance. Hyperemia has been observed in all other ROCK inhibitors developed for glaucoma.
Dr. Jack Elands, CEO of Amakem, said, “AMA0076 has demonstrated IOP reduction without significant hyperemia, the first ROCK inhibitor to achieve this goal in the clinic. The experience we gained in our first-in-human study and the subsequent clinical evaluation of our new formulation gives us great confidence as we begin this dose-ranging study.”
Glaucoma is a leading cause of blindness around the world, claiming the vision of more than 120,000 people in the U.S. alone. There is no cure for the disease, and vision lost cannot be regained. About 10 percent of patients with glaucoma who receive proper treatment are still afflicted with vision loss.
The Phase II dose-ranging study is a double-masked, multicenter, randomized, placebo-controlled study assessing an optimized formulation of AMA0076 administrated topically as eye-drops. The study expects to involve about 80 patients in the U.S. Primary efficacy endpoint will be change in IOP from baseline while secondary endpoints will include IOP assessment as well as safety and tolerability evaluations.
The drug has previously demonstrated IOP reduction without significant hyperemia in previous study with glaucoma and ocular hypertension. An optimized formulation of AMA0076 with improved corneal absorption led to similar results in a subsequent Phase IB study.
Dr. Steve Pakola, CMO of Amakem, said, “Using ROCK inhibition to increase the outflow of aqueous humor from the eye represents a target for glaucoma therapy whose promise is widely recognized. However, development has been held back by the side effect profile of ROCK inhibitors, particularly hyperemia. In AMA0076 we believe we have a candidate that can fully harness the potential of this mechanism of action and thereby provide a potential treatment alternative for this prevalent and serious condition where current treatments do not address the needs of many patients."
The company said that it expects to report top-line results from the trial in the last quarter of 2014.