The US Food and Drug Administration (FDA) has cleared AffaMed Therapeutics’ Investigational New Drug (IND) application for the clinical development 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 vascular diseases, AffaMed notified in a statement.
Under this IND, AffaMed will soon initiate a phase-I study in the US to investigate the safety, tolerability, pharmacokinetics and efficacy of AM712 in subjects with neovascular AMD, the statement added.
AffaMed Therapeutics recently entered into a licensing agreement with AskGene Pharma Inc for the exclusive rights to develop, manufacture and commercialize AM712 in ex-Asia plus Japan territories globally, concluded the statement.