Dose-ranging study initiated for glaucoma candidate

A Phase II dose-ranging study has been initiated for Amakem Therapeutics' glaucoma drug candidate AMA0076.

AMA0076 is a highly potent, locally acting Rho Kinase (ROCK) inhibitor. Based on Amakem's 'localized drug platform', it is designed to reduce intraocular pressure (IOP) while minimizing common ROCK inhibitor side effects such as hyperaemia.

The Phase II dose-ranging study is a multicentre, randomized, double-masked, placebo-controlled study with an optimized formulation of AMA0076 applied topically as eye drops. The study aims to enroll approximately 80 patients in the US (click here for more information).

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 assessments. Amakem expects to report top line results in the fourth quarter.

AMA0076 previously demonstrated IOP reduction without significant hyperaemia in a first-in-human study in patients with glaucoma and ocular hypertension. In a subsequent Phase Ib study, an optimized formulation led to substantial IOP reduction with no significant hyperaemia.

"Using ROCK inhibition to increase the outflow of aqueous humour from the eye represents a target for glaucoma therapy whose promise is widely recognized," says Dr Steve Pakola, chief medical officer, Amakem. "However, development has been held back by the side effect profile of ROCK inhibitors, particularly hyperaemia. 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."

For more information visit www.amakem.com.