- Aptorum Group Limited APM has completed two initial cohorts of the single-dose ascending dose (SAD) portion of the Phase 1 trial evaluating ALS-4 small molecule targeting Staphylococcus aureus.
- Total 6 cohorts for SAD and three cohorts for multiple ascending doses (MAD) have been planned.
- Dosing and safety reviews of Cohort A (25mg) and Cohort B (50mg) have been completed. No human subjects were dropped out of the studies, and there were no Serious Adverse Events observed.
- In addition, no relevant clinical changes regarding vital signs, ECG, clinical laboratory test results, and physical examinations were observed compared to the relevant baseline.
- Cohort C (100mg) studies have been initiated.
- The company also completed the Pre-IND meeting with the FDA related to SACT-1, a repurposed small molecule targeting neuroblastoma.
- SACT-1 is on track to start clinical studies in Q3 of 2021.
- Price Action: APM shares are up 32.4% at $3.15 on the last check Monday.
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