KUALA LUMPUR, Dec 22 — Biopharmaceutical company, Aptorum Group Limited (Aptorum Group or Aptorum) has announced the company, through its wholly owned subsidiary Aptorum International Limited, 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.
According to a statement, ALS-4 is 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.
Aptorum Group Chief Medical Officer and Executive Director, Dr Clark Cheng said: “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 programme.
“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.”
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.
For details, visit www.aptorumgroup.com. – BERNAMA