Aptorum Group Limited announced 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. As 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, single and multiple ascending dose studies (“SAD” and “MAD” respectively) designed to evaluate safety, tolerability, and pharmacokinetics of orally administered ALS-4 in a total of 72 healthy male and female adult volunteers. No Serious Adverse Events were observed on ALS-4 and no relevant clinical changes in respect of vital signs; ECG, clinical laboratory test results and physical examinations were observed compared to the relevant baseline in both SAD (25-200mg) and MAD (50-100mg).