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Aptorum Group Announces Further Positive Interim Results of the Phase 1 Clinical Trial of ALS-4 Targeting Staphylococcus aureus

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company, announces further positive results of its ongoing Phase 1 clinical trial for ALS-4 (a first in-class anti-virulence approach based small molecule targeting Staphylococcus aureus, including, but not limited to Methicillin Resistant Staphylococcus Aureus (“MRSA”)). Specifically, two additional cohorts (Cohort C & D) of the single ascending dose (SAD) portion of the Phase 1 trial in healthy male and female adult subjects have been completed with no serious adverse events observed.[1]

ALS-4’s first-in-human Phase 1 trial is a randomized, double-blinded, placebo-controlled, single (SAD) and multiple ascending dose (MAD) study designed to evaluate safety, tolerability, and pharmacokinetics of orally administered ALS-4 in healthy male and female adult volunteers. Dosing and safety reviews of Cohort C (100mg) and Cohort D (200mg) have been completed, with 8 subjects (6 received ALS-4 and 2 received placebo) were dosed in each cohort. We are pleased to announce that no human subjects were dropped out of the studies and no Serious Adverse Events (SAE) were observed. In addition, no clinically relevant changes in respect of vital signs, electrocardiogram (ECG), clinical laboratory test results and physical examinations were observed compared to baselines. Our SAD is still ongoing to gain additional insights as to the effect of food on bioavailability as well as pharmacokinetics. On this basis, we plan to proceed to MAD in Q3, 2021.[2]

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[1] Dosing and safety reviews of Cohort A (25mg) and Cohort B (50mg) have been completed in May 2021 (see
[2] We plan to conduct 5 total cohorts (plus one optional cohort) for SAD and, thereafter, 3 cohorts for MAD (multiple ascending dose) in Phase 1. As of today, we have completed 4 of the 5 mandatory cohorts for SAD.