Hemera Biosciences is a Boston-based gene therapy company targeting retinal diseases. HMR59, Hemera’s patented complement blocking AAV2 gene therapy platform, is developed to prevent progression of dry age-related macular degeneration (AMD) and its more advanced form, geographic atrophy (GA). AMD is the leading cause of blindness and affects 8 million people in the U.S. and over to 24 million people worldwide. No FDA approved treatment exists to halt the progression of dry AMD with scientific and clinical evidence implicating the complement system as the etiology. HMR59 through its protein product, soluble CD59 (sCD59), blocks the terminal step of the complement cascade at the level of the membrane attack complex (MAC). HMR59 is dosed as a single intraocular injection administered in an office setting whose benefit will last the life of the patient. Additional ocular targets under pre clinical testing include diabetic eye disease and uveitis.
On December 30, 2016 the FDA granted “safe to proceed” status to Hemera's Investigational New Drug (IND) application for HMR59. A phase 1 clinical trial in patients with advanced dry age-related macular degeneration will be initiated in Q1 2017. The FDA’s “Safe to Proceed” status is a critical step forward in testing and evaluating Hemera’s gene therapy for safety and its ability in reducing progression of dry AMD.
For more information please contact Hemera Biosciences at: firstname.lastname@example.org