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Aptorum Group Announces Completion of Pre-IND Discussions with US FDA on its ALS-4, a First-in-Class Small Molecule Drug Targeting Methicillin Resistant Staphylococcus Aureus
NEW YORK & LONDON & PARIS--(BUSINESS WIRE)-- Regulatory News: Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a
About this update from Aptorum Group Limited
[{"type":"text","content":" NEW YORK & LONDON & PARIS--(BUSINESS WIRE)--\nRegulatory News:\n\nAptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company, announces the completion of the Pre-IND discussions with the US Food and Drug Administration (“US FDA”). ALS-4 is a first-in-class small molecule anti-virulence drug targeting infections caused by Staphylococcus aureus, including but not limited to Methicillin Resistant Staphylococcus Aureus (“MRSA”).\n\nUpon the completion of ALS-4’s respective Phase I clinical trials in Canada, ALS-4 has been targeting to obtain the necessary IND clearance for Phase II clinical trials in the United States. The Pre-IND discussions with US FDA focused on overall development plan in preparation for the IND application of ALS-4 targeting Acute Bacterial Skin and Skin Structure Infections (ABSSSI) initially. With the positive feedback on the overall development strategy from the US FDA, Aptorum is now proceeding towards the IND submission of ALS-4.\n\nDr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: “We are pleased to announce the completion of Pre-IND discussions with the US FDA which represents another key milestone the company’s strategic goals for the year of 2023 and for the eventual objective to deliver an exciting novel potential therapeutic solution for the unmet needs of MRSA related infections in human. With additional supportive information from US FDA on the Phase 2 clinical development of ALS-4, it is also the continued focus of Aptorum Group to embark on the exciting Phase 2 clinical trials for ALS-4, subject to further US FDA’s clearance of the IND application”.\n\nAbout ALS-4\n\nAs part of Aptorum Group’s infectious disease platform, ALS-4 is a novel first-in-class orally administered small molecule drug based on an anti-virulence approach targeting staphylococcus aureus including MRSA. ALS-4 targets the antimicrobial resistant properties of the bacteria and is believed to render the bacteria highly susceptible to the host’s immune clearance. ALS-4 is targeted for potential administration on a standalone or on a combination basis with other existing antibiotics such as vancomycin. ALS-4 has completed its first-in-human Phase I trial which was a randomized, double-blinded, placebo-controlled, sin...