AffaMed Therapeutics Announces First Patient Dosed in U.S. Phase 1 Clinical Trial of AM712 for Retinal Diseases

Shanghai, China, May 31, 2021 /PRNewswire/ -- AffaMed Therapeutics, a clinical-stage biopharmaceutical company dedicated to meeting the treatment needs of ophthalmic, neurological, and psychiatric diseases globally, announced today the successful dosing of the first patient in a Phase I clinical study in the United States for AM712 (ASKG712). AM712 is a novel bispecific biomolecule that can simultaneously block vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), and can be used to treat various retinal diseases. The Phase I clinical trial being conducted in the United States will investigate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age-related macular degeneration (nAMD).

Dr. Dayao Zhao, CEO of AffaMed Therapeutics, stated: "The successful completion of the first patient dosing of AM712 undoubtedly reaffirms the excellent execution capabilities and extensive global clinical development experience of the AffaMed team. The official launch of treatment for patients with retinal diseases marks another significant milestone in the development journey of AffaMed Therapeutics. As an innovative and differentiated therapeutic approach, we look forward to accelerating the delivery of AM712 to patients with nAMD and other retinal diseases."

Age-related Macular Degeneration (AMD) is an acquired retinal disease characterized by significant loss of central vision due to neovascularization (choroidal neovascularization) and non-neovascular degeneration (drusen and retinal pigment epithelium abnormalities). Clinically, nAMD represents the advanced stage of macular degeneration and is the primary cause of AMD-related vision loss. As an innovative candidate treatment, simultaneously neutralizing VEGF and Ang-2 could provide a more effective therapy for nAMD.

At the end of 2021, AffaMed Therapeutics entered into a licensing agreement with AskGene Pharma Inc. (AskGene) to obtain exclusive rights to develop, manufacture, and commercialize AM712 in regions outside of Asia and Japan. In January 2022, the Investigational New Drug (IND) application for AM712 initiated by AffaMed Therapeutics received approval from the U.S. Food and Drug Administration (FDA).