Date: 2012-09-27
Type of information:
phase: 2a
Announcement: initiation of the phase 2a trial
Company: Amakem (Belgium)
Product: AMA0076
Action
mechanism: AMA0076 is a Rho Kinase (ROCK) inhibitor. It 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. Pre-clinical studies have shown that AMA0076 highly effectively lowers IOP in relevant models, with a magnitude of IOP reduction exceeding that of the current leading glaucoma treatment latanoprost.
Disease: glaucoma
ocular hypertension
Therapeutic area: Ophtalmological diseases
Country: USA
Trial
details: 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 (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.
Latest
news: Amakem , a kinase platform company focusing on ophthalmology, thas 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 FDA. The Company expects to report top line results in 2013.
