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AffaMed Digital Announces Enrollment of First Patient in China Clinical Trial Investigating its Experimental Digital Therapeutic AMD201 for the Treatment of Post-stroke Cognitive Impairment

April 06, 2023

AffaMed Digital, a wholly owned subsidiary of AffaMed Therapeutics dedicated to developing and commercializing evidence-based, clinically validated digital medicines to treat, diagnose, prevent, and/or manage medical disorders or diseases, today announced the first patient enrollment in its China study of AMD201, a prescription-only digital therapeutic (DTx) intended for the treatment of Post-Stroke Cognitive Impairment (PSCI) in adults, at Beijing Tiantan Hospital. This study, which is a randomized, controlled, single-blinded and multicenter clinical trial, will assess the safety and efficacy of AMD201 in restoring cognitive function in patients with PSCI.

Dr. Dayao Zhao, CEO of AffaMed commented: “Treating the first patient with AMD201 marks an important milestone for AffaMed in demonstrating our team’s unique expertise in the clinical development of digital therapies as a novel evidence-based therapeutic approach offering exciting new disease treatment options, including encouraging clinical performance in the field of cognitive behavior. AffaMed focuses on neurological and psychiatric disorders and is committed to continuing to discover and develop innovative therapies in our targeted therapeutic areas.”

PSCI encompasses cognitive impairments manifesting in the 3 to 6 months after stroke. These impairments persist in many individuals for years with substantial impact on day-to-day functioning, and are associated with higher disability, and a greater institutionalization rate. However, currently there is no pharmacological treatment approved specifically for PSCI. AMD201, a computerized cognitive training product that consists of a series of training games adapted from classic scientific paradigms, provides a novel, non-pharmacological approach to address several key cognitive deficiencies found in PSCI patients.

In late 2021, AffaMed announced a strategic partnership with the Beijing Tiantan Hospital of Capital Medical University and Beijing Infinite Brain Technologies (“IBT”) to collaborate on the clinical development of digital therapies in neurological diseases, followed by an agreement with IBT to in-license global rights to develop and commercialize novel DTx programs for the treatment of PSCI and other indications. A first Investigator Initiated Trial (IIT) of the treatment candidate in PSCI led by Dr. Yongjun WANG, President of Beijing Tiantan Hospital, was completed in early 2022.

About AffaMed Therapeutics

AffaMed Therapeutics is a clinical stage therapeutic company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmic, neurological and psychiatric disorders for patients in Greater China and around the world.