Hemera Biosciences has announced that the FDA has granted “safe to proceed” status to the investigational new drug application for HMR59 on December 30, 2016. A phase 1 clinical trial in patients with advanced dry age-related macular degeneration will be initiated in the first quarter of 2017.
Hemera's lead product is HMR59, an AAV2-based gene therapy, which blocks complement overactivity by inhibiting membrane attack complex (MAC). HMR59 will be initially evaluated as a single intravitreal injection in dry age related macular degeneration (AMD). Hemera anticipates testing HMR59’s efficacy in other chronic complement mediated diseases as well.
The FDA’s “safe to proceed” status is a critical step forward in testing and evaluating Hemera’s gene therapy for safety and evaluating its ability in reducing progression of dry AMD.