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Aptorum Group Announces Further Positive Data For Its ALS-4 Small Molecule Anti-virulence (Non-bactericidal) Drug Candidate For The Treatment of Infections Caused By Staphylococcus Aureus and On Track Targeted For IND Submission in H2 2020
HONG KONG, Feb 11, 2020 - (ACN Newswire) - - Aptorum Group Limited (NASDAQ: APM) ("Aptorum Group"), a biopharmaceutical company focused on the development of
About this update from Aptorum Group Limited
[{"type":"text","content":"HONG KONG, Feb 11, 2020 - (ACN Newswire) - - Aptorum Group Limited (NASDAQ: APM) (\"Aptorum Group\"), a biopharmaceutical company focused on the development of novel therapeutics to address global unmet medical needs, announces further positive data from its current 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. aureus\"), including methicillin-resistant Staphylococcus aureus (MRSA, one of the \"super-bugs\"), based on a novel anti-virulence non-bactericidal approach. Subject to completion of the current studies, Aptorum Group targets to submit IND for ALS-4 in second half of 2020 and commence a phase 1 trial in North America.ALS-4 is a small molecule which inhibits dehydrosqualene desaturase of S. aureus (incl. MRSA), an enzyme that is critically involved in the biosynthesis of staphyloxanthin, a commonly visible \"golden pigment\" covering the bacteria. Staphyloxanthin is believed to be primarily responsible for the bacteria's defense mechanism against the attack from reactive oxygen species (ROS) deployed by phagocytic cells and neutrophils.1Through inhibiting the production of staphyloxanthin, we believe that ALS-4 renders S. aureus highly susceptible to the host's immune defense (see below for in vivo data and experimental outline). This novel mechanism is significantly different from the bactericidal approach found in currently marketed antibiotics used to treat S. aureus, which are experiencing increasing drug resistance issues2. Specifically, MRSA infections in humans typically exhibit high rates of morbidity and mortality and can cause metastatic or complicated infections such as infective endocarditis or sepsis, with relapse and hospital readmission after S. aureus bacteremia common and costly3.Based on our testing in a rat bacteremia survival model, a lethal (109 CFU) dose of MRSA (USA300-LAC) was introduced through the tail vein. ALS-4 was administered orally at 10mg/kg per animal 30 minutes after the infection for twice a day thereafter (N=9). A control untreated group was given a sterile vehicle solution (N=9). Survival was monitored for 7 days. 0 out of 9 animals (0%) in the control untreated group survived past day 4, in contrast, 5 out of 9 animals (56%) treated with ALS-4 survived past ...