Aptorum Group Ltd. (NASDAQ: APM) stock declined by 4% at last close whereas the APM-stock price gains by 6.44% in the pre-market trading session. Aptorum Group Limited is a clinical-stage pharmaceutical business focused on discovering, developing, and commercializing therapeutic assets for illnesses with unmet medical needs, notably in cancer (including orphan oncology indications) and infectious diseases.
Recent Past Development
Aptorum Group Limited has released further good results from its ongoing ALS-4 Phase 1 clinical study. Two further cohorts (Cohort C & D) of the single ascending dosage portion of the Phase 1 study in healthy male and female adult volunteers were finished with no severe side events.
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The first-in-human Phase 1 study for ALS-4 is a randomized, double-blind, placebo-controlled, single, and multiple ascending dosage research in normal male and female participants to assess the safety, acceptability, and pharmacokinetics of orally given ALS-4. Cohort C (100mg) and Cohort D (200mg) dosing and safety evaluations have been conducted, with 8 individuals (6 having ALS-4 and 2 receiving placebo) dosed in each cohort.
ALS-4 is a new first-in-class orally given small molecule medication focused on an anti-virulence strategy targeting staphylococcus aureus, including MRSA, and is part of Aptorum Group’s Acticule infectious disease platform. The antimicrobial resistance characteristics of the bacteria are targeted by ALS-4, which is thought to make the bacterium extremely vulnerable to the host’s immunological clearance. ALS-4 is being developed for use as a stand-alone antibiotic or in combination with other antibiotics like as vancomycin.
They are happy to report that no human volunteers were withdrawn from the trials and that no Serious Adverse Events were reported. In addition, there were no clinically significant differences in vital signs, electrocardiograms, clinical laboratory test findings, or physical exams when compared to baselines. The SAD is still continuing in order to learn more about the impact of diet on bioavailability and pharmacokinetics. On this basis, we anticipate moving to MAD in Q3 of 2021.