AffaMed Therapeutics has announced the dosing of the first subject in the Phase I clinical trial of AM712 (ASKG712) to treat retinal diseases in the US.
A new bispecific biologic molecule, AM712 hinders both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2).
Intended specially for ocular usage, the molecule showed good ocular pharmacokinetics and an anticipated safety profile that backs further clinical exploration, in pre-clinical studies.
The trial will assess AM712’s safety, tolerability, pharmacokinetics and efficacy in participants with neovascular age-related macular degeneration (nAMD).
AffaMed Therapeutics CEO Dr Dayao Zhao said: “Dosing the first patient with AM712 is another example of the AffaMed team’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.”
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Last year, the company signed a licencing agreement with AskGene Pharma to obtain exclusive global rights for the development, production and marketing of AM712 in territories outside Asia but including Japan.
In January this year, the US Food and Drug Administration (FDA) granted clearance to the Investigational New Drug (IND) application submitted by AffaMed to clinically advance AM712.
An advanced type of macular degeneration, nAMD is a key cause of vision loss associated with AMD.
Neutralisation of VEGF and Ang-2 at the same time represents a new therapeutic approach for treating nAMD with enhanced efficacy.
A clinical-stage biopharmaceutical company, AffaMed focuses on the development and marketing of transformative pharmaceutical, digital and surgical products.