The study will investigate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with neovascular age-related macular degeneration.
AffaMed Therapeutics announced this week that the first patient has been dosed in its U.S. Phase 1 study of AM712 (ASKG712), a novel proprietary bispecific biologic molecule blocking both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) for the treatment of retinal diseases.
According to the company, the study will investigate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with neovascular age-related macular degeneration (nAMD).
Dayao Zhao, MD, PhD, CEO of AffaMed, pointed out that the dosing of the first patient with AM712 demonstrates the company’s effective execution and global clinical development expertise.
“Initiating treatment in retinal disease patients marks an important milestone for AffaMed, and we look forward to advancing AM712 as an innovative and differentiated therapy for the patient population with nAMD and other retinal diseases,” Zhao said in a statement.
Age-related macular degeneration (AMD) is an acquired degeneration of the retina that results in significant central vision loss due to neovascular (choroidal neovascular membrane formation) and non-neovascular (drusen and retinal pigment epithelium abnormalities) damages. Neovascular AMD is an advanced form of macular degeneration that has historically been the leading cause of AMD-related vision loss. Simultaneous neutralization of VEGF and Ang-2 represents a novel therapeutic approach to treat nAMD with better efficacy.
The company noted that in late 2021, it entered into a licensing agreement with AskGene Pharma Inc. for the exclusive rights to develop, manufacture, and commercialize AM712 globally in ex-Asia plus Japan territories.
Soon after, the Investigational New Drug (IND) application, filed by AffaMed for the clinical development of AM712 was cleared by the FDA in January.
AM712 is a novel bispecific biologic molecule specifically designed for ocular use. It provides dual inhibition of two important disease-relevant pathways in retinal diseases, VEGF and Ang-2. In pre-clinical studies, AM712 demonstrated robust efficacy, good ocular pharmacokinetics, and the desired safety profile supporting clinical exploration. AskGene received China CTA clearance for AM712 from NMPA in January.