CoMentis Begins Trial of Wet AMD Drug

CoMentis has announced the initiation of a Phase II clinical study of ATG3, the company's topical therapy for wet age-related macular degeneration (AMD).

A proprietary ophthalmic formulation of mecamylamine, ATG3 is an antagonist of the nicotinic acetylcholine receptor pathway that mediates angiogenesis. The drug was developed to effectively penetrate into the retina and choroid following topical eye drop administration, the company said.

This Phase II study is a double-blind, randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of ATG3 in patients with wet AMD. Approximately 330 patients will be randomized to one of three treatment groups: two different doses of ATG3 or placebo administered by eyedrop twice daily. One eye per patient will receive the study treatment. All patients will be treated for up to 48 weeks, during which time they will be monitored for safety, tolerability and efficacy assessments. Patients will be assessed for change in visual acuity and macular thickness using ocular coherence tomography.

Inhibition of the nicotinic acetylcholine receptor pathway also down-regulates vascular endothelial-derived growth factor dependent angiogenesis, according to CoMentis. Studies in animal models have demonstrated excellent penetration of the proprietary ATG3 formulation to the retina and choroid following eyedrop application as well as a reduction in new blood vessel growth.