USFDA gives nod to this Molecule to treat retinal vascular diseases

AM712 (ASKG712) is a novel proprietary bispecific biologic molecule

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USFDA Approval
USFDA Approval

Last Updated on October 15, 2024 by The Health Master

The US Food and Drug Administration (USFDA) has cleared AffaMed Therapeutics’ Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712).

AM712 (ASKG712) is 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.

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