NEW YORK & LONDON & PARIS–(BUSINESS WIRE)–Mar. 31, 2021– Regulatory News: 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 dosing the first human subject in its Phase I clinical trial evaluating ALS-4, an orally-administered small molecule drug for the treatment of infections caused by Staphylococcus aureus including MRSA.
The first-in-human Phase I trial is a randomized, double-blinded, placebo-controlled, single and multiple ascending dose study designed to evaluate safety, tolerability, and pharmacokinetics of orally administered ALS-4 in healthy male and female adult volunteers. The study plans to enroll up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple-ascending dose (MAD) cohorts, respectively. Enrollment for the first cohort of SAD has been completed and we continue to enroll individuals for other cohorts of the trial.
Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: “The first human subject dosed in the ALS-4 clinical trial marks a significant milestone toward delivering a new mechanism of action for the potential treatment of infections caused by Staphylococcus aureus including MRSA. Since 1958, when vancomycin was first approved, only one additional agent, daptomycin (of which both antibiotics are primarily IV based treatment requiring patients to remain in in-patient settings during treatment) has gained regulatory approval for the treatment of MRSA bacteremia and despite this, clinical failure and mortality rates for this major infectious disease remain critically high. Subject to the upcoming clinical trial, we believe ALS-4 could be a potential new anti-infective agent adopting a unique anti-virulence approach to achieve effective outcomes for these patients. We are excited to embark on our Phase I trial and are looking forward to completing the trial as swiftly as possible.”
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