Aptorum ends pre-IND talks with FDA on therapy for Methicillin Resistant Staphylococcus Aureus

 Aptorum 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”).

Upon 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.

Dr. 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”.

https://www.biospace.com/article/releases/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/