A leader in lipidomics-based therapeutics, Lpath, Inc. announced today that it has completed the enrollment and dosing of 15 wet AMD patients in a multi-center, open label, single-arm Phase 1 study of iSONEP. The iSONEP was administered as a single intravitreal injection to the study eye. The company is expected to release a complete analysis of efficacy when all data becomes available.
All 15 patients tolerated the drug well, and there were no drug-related serious events reported at any of the five dose levels. Additionally, several patients showed a reduction in retinal thickness and regression of lesion size, two primary efficacy-related endpoints in a Phase 1 trial. Previously, all of these patients had failed to respond to LucentisÂ® and/or AvastinÂ®, the two leading treatment options for wet AMD patients, inferring that their lesions were already difficult to treat.
Scott Pancoast, Lpath’s President and Chief Executive Officer, stated, “The excellent safety record from our Phase 1 study, combined with the efficacy signal from several of the patients, warrants further investigation of the safety and efficacy of iSONEP in one or more Phase 2 trials.”