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Aptorum Group Announces Completion of End of Phase 1 (EOP1) Meeting with US FDA on its SACT-1, a Repurposed Small Molecule Drug Targeting Neuroblastoma
NEW YORK & LONDON & PARIS--(BUSINESS WIRE)-- Regulatory News: Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a
About this update from Aptorum Group Limited
[{"type":"text","content":" NEW YORK & LONDON & PARIS--(BUSINESS WIRE)--\nRegulatory News:\n\nAptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company, announces the completion of an end of Phase 1 (EOP1) meeting with the US Food and Drug Administration (“US FDA”). SACT-1 is a repurposed small molecule drug formulated in oral suspension targeting neuroblastoma in pediatric patients and has also received orphan drug designation previously from the US FDA.\n\nThe EOP1 meeting was focused on gaining alignment with the US FDA regarding the clinical and regulatory pathway for SACT-1 for the treatment of neuroblastoma in pediatric patients aged 2-18. The FDA generally agreed with the chemistry-manufacturing-control (CMC) strategy and our proposed clinical development plan for Phase 1/2 trials.\n\nDr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: “We are pleased to announce the completion of End of Phase 1 Meeting with US FDA and this represents another key milestone for the company and one of the targeted strategic goals for the year of 2023. With additional supportive information from US FDA on the clinical development of SACT-1, this supports the continued focus of Aptorum Group to embark on the exciting Phase 1/2 clinical trials for SACT-1, subject to further FDA’s clearance of the final clinical protocol.”\n\nAbout SACT-1\n\nSACT-1 is an oral suspension based repurposed small molecule drug formulated in oral suspension 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. SACT-1 has been observed to be potentially applicable to neuroblastoma and other cancers in the preclinical studies.\n\nAbout Aptorum Group\n\nAptorum 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), autoimmune and infectious di...