Tuesday, December 05, 2023
Aptorum Group Limited (Nasdaq: APM) (“Aptorum Groupâ€), a biopharmaceutical company focused on the development of novel therapeutics to address global unmet medical needs, announces that it has initiated investigational new drug (IND)-enabling studies for ALS-4, a small drug molecule candidate indicated for the treatment of infections caused by Staphylococcus aureus (or “S. aureusâ€) including methicillin-resistant Staphylococcus aureus (MRSA, i.e., one of the commonly known “super-bugsâ€) based on a novel anti-virulence approach.
The ALS-4 candidate has been progressing well and the first series of GLP toxicology studies have been completed through an appointed North American based contract research organization (CRO). In particular, ALS-4 candidate did not show any mutagenicity in the in vitro Ames tests. ALS-4 development is on track and the company targets to submit the related IND in the first half year of 2020 and a hybrid Phase 1 clinical study is currently planned in North America with both healthy volunteers and patients to obtain preliminary efficacy readout.
S. aureus is a bacteria which is a leading cause of blood, lung, skin, bone and device-related infections, as well as toxin-related diseases1. It is estimated that patients with S. aureus bacteremia have an average mortality rate of 30%2 and that it is responsible for causing more deaths than AIDS, tuberculosis and viral hepatitis combined3. MRSA and vancomycin-intermediate and resistant S. aureus have also been classified by the World Health Organization (WHO) as high priority pathogens for research and development4.
