Amakem begins phase II trial for glaucoma treatment

Diepenbeek, Belgium-Amakem Therapeutics announced that first patients have commenced treatment in a phase II dose-ranging study of its lead drug candidate-AMA0076-for the treatment of glaucoma.

The drug is a highly potent locally acting Rho Kinase (ROCK) inhibitor that has been designed to reduce IOP by acting specifically on the main outflow system in the eye while minimizing side effects such as hyperemia.

The phase II dose-ranging study is a multicenter, randomized, double-masked, placebo-controlled study with an optimized formulation of the drug applied topically as eye drops. The study aims to enroll about 80 patients in the United States.

The primary efficacy endpoint will be change in IOP from baseline at the end of 28 days of treatment. Secondary endpoints include IOP assessment at other time points as well a safety and tolerability assessment.

The company said it expects to report top line results in the fourth quarter of 2014.

AMA0076 has previously demonstrated IOP reduction without significant hyperemia in a first-in-human study in patients with glaucoma and ocular hypertension.

An optimized formulation with significantly improved corneal absorption led to substantial IOP reduction with no significant hyperemia in a subsequent phase Ib study.

"(This drug) has demonstrated IOP reduction without significant hyperemia, the first ROCK inhibitor to achieve this goal in the clinic,” said Jack Elands, PhD, chief executive officer of Amakem. “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."

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