This article is more than 5 years old. Information may no longer be current.
FDA grants Hemera's dry AMD gene therapy safe to proceed status
Hemera Biosciences’ investigative new drug application for HMR59 has been granted safe to proceed status from the FDA, the company announced in a press release.
HMR59, an AAV2 gene therapy, blocks complement overactivity by inhibiting membrane attack complex, the release said.
A phase 1 clinical trial evaluating a single intravitreal injection in patients with advanced dry age-related macular degeneration is planned to begin in the first quarter of 2017, according to the release.
“HMR59 has the potential to slow down or stop the progression of dry AMD with a single intravitreal injection. If shown to be safe and effective, this therapy would prove to be a huge advance for a disease that has no FDA-approved therapy,” company co-founder Jay S. Duker, MD, told Healio.com.
The company also intends to test the gene therapy in other chronic complement-mediated diseases.
Disclosure: Duker reports he is a founder of and major shareholder in Hemera Biosciences.