Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company, is pleased to announce the finalized data from the Phase 1 clinical trial of SACT-1, a repurposed small molecule drug targeting Neuroblastoma and potentially other cancer types.
Following the announcement of the Phase 1 clinical trial of SACT-1 in January 2022, Aptorum is pleased to announce further data updates from the trial conducted by an independent clinical contract research organization. The Phase 1 clinical trial of SACT-1 was an open-label, randomized, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study of SACT-1 (oral suspension) in healthy adult volunteers. The primary objective of this study was to assess the relative bioavailability of 150 mg of SACT-1 (oral suspension) under fasted and fed conditions. The secondary objectives were to evaluate the safety, tolerability and any potential QT prolongation after a single oral administration of 150mg of the studied drug under fasted and fed conditions in healthy adult subjects. The study treatments were well tolerated and no subjects were discontinued from study participation because of adverse events. No serious adverse events were reported during the study. The phase 1 clinical data also suggested that any QT interval after oral administration of SACT-1 at 150mg was well within clinically acceptable limits. Regarding the relative bioavailability under the Fed vs Fasted condition, the AUC0-tlast, AUC0-∞ and Cmax ratio of SACT-1 were determined to be 189.87%, 189.43%, and 205.25% respectively.
Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: “Further to our previous announcements, we are very encouraged by the impressive safety data even at a relatively high dosage. The relative bioavailability data also enabled us to estimate the starting dose for pediatric neuroblastoma patients via PK modeling. We are planning to meet with the US FDA for an end of Phase 1 meeting as soon as possible and are targeting for submission for a Phase 1b/2a clinical trial in neuroblastoma patients.”
SACT-1 is an orally administered repurposed small molecule drug to target neuroblastoma. SACT-1’s mechanism has been investigated in our preclinical studies to enhance tumor cell death and suppress MYCN expression (a common clinical diagnosis in high-risk or relapsed neuroblastoma patients where an amplification of MYCN is usually observed). SACT-1 is designed to be used especially in combination with standard-of-care chemotherapy.
About Aptorum Group
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic assets to treat diseases with unmet medical needs, particularly in oncology (including orphan oncology indications) and infectious diseases. The pipeline of Aptorum is also enriched through (i) the establishment of drug discovery platforms that enable the discovery of new therapeutics assets through, e.g. systematic screening of existing approved drug molecules, and microbiome-based research platform for treatments of metabolic diseases; and (ii) the co-development of a novel molecular-based rapid pathogen identification and detection diagnostics technology with Accelerate Technologies Pte Ltd, commercialization arm of the Singapore’s Agency for Science, Technology and Research.
For more information about the Company, please visit www.aptorumgroup.com.
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