Aptorum Group Limited (NASDAQ: APM) receives clearance from the Public Health Agency of Canada in regards to its Clinical Trial Application to begin Phase 1 study of ALS-4, its orally taken small molecule drug that is intended to treat infections that are caused by Staphylococcus aureus that includes 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 clinical trial is planned in Canada and will target 24-48 healthy volunteers for single ascending dose and multiple ascending dose. The primary goal of the trial is to evaluate the safety and tolerance of SAD and MAD of ALS-4 administered orally to healthy individuals.