Amakem Therapeutics, a clinical stage ophthalmology company, today announced that first patients have commenced treatment in a Phase 2 dose-ranging study of its lead drug candidate, AMA0076 for the treatment of glaucoma.
Based on Amakem's 'Localized Drug Action' platform, AMA0076 is a highly potent locally-acting Rho Kinase (ROCK) inhibitor that has been designed to reduce intraocular pressure (IOP) by acting specifically on the main outflow system in the eye while minimizing side effects such as hyperemia ('red eye'). Hyperemia, a particularly problematic side effect leading to patient non-compliance, has been seen with all other ROCK inhibitors developed for glaucoma.
The Phase 2 dose-ranging study is a multicenter, randomized, double-masked, placebo-controlled study with an optimized formulation of AMA0076 applied topically as eye-drops. The study aims to enrol approximately 80 patients in the United States (ClinicalTrials.gov identifier NCT02136940).
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. The Company expects to report top line results in Q4 2014.
AMA0076 has previously demonstrated IOP reduction without significant hyperemia in a first-in-human study in patients with glaucoma and ocular hypertension, as presented at the Ophthalmology Innovation Summit (OIS) at the 2013 Annual Meeting of the American Academy of Ophthalmology. An optimized formulation with significantly improved corneal absorption led to substantial IOP reduction with no significant hyperemia in a subsequent Phase 1b study.
Dr. Jack Elands, Chief Executive Officer 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."
Dr. Steve Pakola, Chief Medical Officer of Amakem, said: "Glaucoma remains a significant cause of vision loss and blindness and affects many millions of people worldwide. 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."
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