Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a biopharmaceutical company focused on novel technologies for the treatment of a variety of medical conditions including infectious diseases, announced that the company, through its wholly owned subsidiary Aptorum International Limited, has submitted a Clinical Trial Application (CTA) with the Public Health Agency of Canada (Health Canada) to conduct a Phase 1 clinical trial of ALS-4, an orally administered small molecule drug for the treatment of infections caused by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA). Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers.
Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: “Further to our previous update in September 2020, we are pleased to announce this CTA submission which represents a major development milestone for our ALS-4 antimicrobial program. ALS-4 is a novel small molecule adopting an anti-virulence (non-antibiotic) approach to address the growing unmet medical needs of infections caused by Staphylococcus aureus. ALS-4 is an orally administered drug and thereby aligning with global healthcare policy to actively promote the switch from an IV to oral based antimicrobial treatment ,,. As shown in our internal preclinical data and subject to further clinical trials, ALS-4 can be potentially used on a standalone basis or in combination with existing antibiotics (for example, vancomycin) with the aim to reduce mortality and morbidity of the infected patients especially in severe cases. We believe that our orally administered ALS-4 drug can potentially also tackle a variety of infections caused by Staphylococcus aureus, including (but not limited to) MRSA bacteremia and skin & soft tissue infections, subject to the respective clinical trials.”
The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 32 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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