NEWS | BEAM Alliance


Aptorum Group Receives Clearance from Health Canada to Initiate a Phase 1 Clinical Trial for ALS-4, a Small Molecule Drug for Infections Caused by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA)

NEW YORK & LONDON & PARIS–(BUSINESS WIRE)–Jan. 20, 2021– Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ) (“Aptorum Group” or “Aptorum”), a biopharmaceutical company focused on novel technologies including the targeting of infectious diseases, announced that the company, through its wholly owned subsidiary, Aptorum International Limited, has received clearance from the Public Health Agency of Canada (Health Canada) regarding the Clinical Trial Application (CTA) to commence a Phase 1 study of ALS-4, an orally administered small molecule drug intended to treat infections caused by Staphylococcus aureus including MRSA.

Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented, “The clearance of our CTA application for ALS-4 drug represents a significant milestone for the company and one of a number of targeted strategic goals for 2021. This milestone supports the transition of Aptorum Group to a clinical-stage company and reflects the potential of our scientific rigor and novel approach of our products. We are dedicated to delivering novel therapeutics in the field of growing unmet medical needs of infections starting with Staphylococcus aureus.”

The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. The primary objective of the trial is to evaluate the safety and tolerability of SAD and MAD of ALS-4 administered orally to healthy subjects. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects.

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