NEW YORK, Sept 10 (Bernama-BUSINESS WIRE) -- Aptorum Group Limited (Nasdaq: APM) (“Aptorum Group”), 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. aureus”) including methicillin-resistant Staphylococcus aureus (MRSA, i.e., one of the commonly known “super-bugs”) 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 diseases
1. 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 combined
3. 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 development
4.
About ALS-4ALS-4 is a small molecule drug candidate that is believed to inhibit dehydrosqualene desaturase of S. aureus (incl. MRSA) which is involved in the generation of staphyloxanthin, a commonly visible “golden pigment” covering the bacteria and is primarily responsible for the bacteria’s resistance to attack from reactive oxygen species (ROS) deployed by phagocytic cells and neutrophils
5. On this basis, ALS-4 is not bactericidal and through inhibiting the production of staphyloxanthin, S. aureus becomes highly susceptible to the host’s immune clearance. ALS-4 deploys a novel approach towards the treatment of bacterial infection which is significantly different from the bactericidal approach found in most current antibiotics that are experiencing increasing drug resistance issues.
About Aptorum Group LimitedAptorum Group Limited (Nasdaq: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs. Aptorum Group is pursuing therapeutic projects in neurology, infectious diseases, gastroenterology, oncology and other disease areas.
For more information about Aptorum Group, please visit
www.aptorumgroup.com.
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