1 April 2021 - - The first human subject has been dosed in biopharmaceutical company Aptorum Group Ltd's (NASDAQ: APM) (Euronext Paris: APM) 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 company said.

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 and multiple-ascending dose cohorts, respectively.

Enrollment for the first cohort of SAD has been completed and the company continues to enroll individuals for other cohorts of the trial.

As part of Aptorum Group's Acticule infectious disease platform, ALS-4 is a novel first-in-class orally administered small molecule drug based on an anti-virulence approach targeting staphylococcus aureus including MRSA.

ALS-4 targets the antimicrobial resistant properties of the bacteria and is believed to render the bacteria highly susceptible to the host's immune clearance. ALS-4 is targeted for potential administration both on a standalone or a combined basis with other existing antibiotics such as vancomycin.

Aptorum is a biopharmaceutical company dedicated to the discovery, development and commercializing of therapeutic assets to treat diseases with unmet medical needs, particularly infectious diseases and cancers (including orphan oncology indications).