Amakem initiates phase 2 study of investigational glaucoma agent
Amakem Therapeutics announced its initiation of a phase 2 dose-ranging study for the investigational glaucoma agent, AMA0076, according to a press release.
The locally-acting Rho-kinase (ROCK) inhibitor has been developed to reduce IOP by targeting the main outflow system in the eye.
“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,” Jack Elands, PhD, CEO of Amakem, said in a press release.
The company plans to enroll approximately 80 patients in the United States for the phase 2 dose-ranging, multicenter, randomized, double-masked, placebo-controlled study. Researchers will investigate changes in IOP from baseline to 28 days after start of therapy and other time points, as well as safety and tolerability of the agent.
Previous research on the agent was presented at the Ophthalmology Innovation Summit during the American Academy of Ophthalmology Annual Meeting in 2013. Further data are expected to be released later this year, according to the release.
For more information:
ClinicalTrials.gov identifier: NCT02136940.