Amakem Initiates Phase 2a Proof of Concept Study with the Rho Kinase (ROCK) Inhibitor AMA0076 in Patients with Glaucoma and Ocular Hypertension under a US IND

Amakem Initiates Phase 2a Proof of Concept Study with the Rho Kinase (ROCK) Inhibitor AMA0076 in Patients with Glaucoma and Ocular Hypertension under a US IND PR Newswire DIEPENBEEK, Belgium, September 27, 2012 DIEPENBEEK, Belgium, September 27, 2012 /PRNewswire/ -- Amakem NV, a kinase platform company focusing on ophthalmology, today announces that it has initiated a Phase 2a proof of concept study of its novel Rho Kinase (ROCK) inhibitor, AMA0076, in patients with glaucoma and ocular hypertension. The start of the study follows Amakem's receipt of Investigational New Drug Application (IND) approval from the United States Food and Drug Administration (FDA). AMA0076 is a highly potent ROCK inhibitor and is based on Amakem's 'Localized Drug Action' platform, which generates novel kinase inhibitors that minimize the risk of systemic as well as local side effects such as hyperemia. The study is a multicenter, randomized, double-masked, placebo-controlled dose-escalation study with AMA0076 applied topically, as eye drops. First patients have initiated treatment in this 80 patient clinical trial with six participating centers in the United States (ClinicalTrials.gov identifier NCT01693315). The primary efficacy endpoint will be reduction in intraocular pressure (IOP), which is a major factor in the pathology of glaucoma, after two and four weeks of dosing. A number of secondary efficacy endpoints will be used to further analyze the impact of AMA0076 on IOP.