Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) (“Aptorum Group”), a biopharmaceutical company focused on novel therapeutics including the development of next-generation approach therapeutics targeting antimicrobial resistance, announced two sets of positive data showing both significant in vivo activities of its lead compound ALS-4 against Methicillin-Resistant Staphylococcus aureus (MRSA, one of the “super-bugs”) in wound infected and bacteraemia mouse models, respectively when compared to prevailing antibiotics.
ALS-4 is currently undergoing final stages of IND enabling studies, which involves a 14-Day oral toxicity in rats and dogs, a functional observation battery study in rats and a cardiovascular telemetry and respiratory study in dogs. Subject to the final IND-enabling studies results, ALS-4 is on track to target the regulatory submission in Q4 2020 subject to which to commence Phase I clinical trials in Canada.
“Despite the two current mainstay treatments, vancomycin and daptomycin, being the only FDA approved antibiotics for MRSA bacteraemia thus far, patient mortality, morbidity and recurrence rates remain significant[1]. With the fragile antibiotic pipeline being at risk globally, antimicrobial resistance issues continue to gain significant attention from global bodies including the World Health Organization and the FDA, as well as the pharmaceutical industry. We believe that our oral ALS-4 drug based on a novel first-in-class anti-virulence concept can potentially tackle a variety of infections related to MRSA, including (but not limited to) bacteraemia and skin & soft tissue infections, subject to the respective clinical trials. We are greatly encouraged by the data because ALS-4 appears to be effective against MRSA superbug and could be a potential alternative and sustainable treatment for different MRSA indications including, but not limited to, MRSA bacteraemia and skin infections. ALS-4’s anti-virulent properties are a novel approach in tackling antimicrobial resistance issues as encouraged by recent global action plans. We are also pleased to report that our IND enabling studies are also at their final stages and we remain on track to target regulatory submission to commence phase 1 clinical trials,” said Mr. Darren Lui, President and Executive Director of the company. […]
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