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Fortress Biotech and Cyprium Therapeutics Announce Positive Clinical Data for CUTX-101, Copper Histidinate, Presented at 2021 American Academy of Pediatrics National Conference & Exhibition
Cyprium Therapeutics, a partner company of Fortress Biotech, is developing CUTX-101 for the treatment of Menkes disease Overall survival significantly
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Cyprium Therapeutics, a partner company of Fortress Biotech, is developing CUTX-101 for the treatment of Menkes disease\n Overall survival significantly improved in patients treated with CUTX-101\n Rolling submission of New Drug Application to the FDA for CUTX-101 planned to begin in fourth quarter of 2021; potential to be first FDA-approved treatment for Menkes disease\n\n\nNEW YORK and SOLANA BEACH, Calif., Oct. 13, 2021 /PRNewswire/ -- Cyprium Therapeutics, Inc. (\"Cyprium\"), a Fortress Biotech, Inc. (Nasdaq: FBIO) (\"Fortress\") partner company, with support from its licensing partner Sentynl Therapeutics, Inc. (\"Sentynl\"), a wholly owned subsidiary of Cadila Healthcare Limited (\"Zydus\"), today announced positive results from an efficacy and safety analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101, copper histidinate (CuHis). In both pre-specified primary and secondary efficacy analyses, treatment with CUTX-101 demonstrated a significantly greater median overall survival (OS) compared to untreated historical control patients. These data will be presented as a virtual poster at the 2021 American Academy of Pediatrics National Conference & Exhibition. More information on the poster is listed below:\nVirtual Poster Title: Copper Histidinate Treatment for Menkes Disease (Kinky Hair Syndrome)Presentation Date: Friday, October 08, 2021Session: (VH1410) Section on Advances in Therapeutics and Technology ProgramAuthors: Stephen G. Kaler, M.D., M.P.H., Shama Munim, M.S., Michael Chen, Ph.D., Robert Niecestro, Ph.D., Lung S. Yam, M.D., Ph.D. \n\"There is a significant unmet need for an approved treatment for patients with Menkes disease. These positive data demonstrate the potential of CUTX-101 to be an effective therapy for patients with this devastating disease. We look forward to working with the U.S. Food and Drug Administration (\"FDA\") to begin our rolling submission of a new drug application (\"NDA\") for CUTX-101 in the fourth quarter of this year,\" said Lung S. Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium. \nIn two completed open-label, single-arm, single-site studies, 129 patients with Menkes disease were treated with CUTX-101 (1450 mcg CUTX-101, equivalent to 250 mcg elemental copper) administered subcutaneously twice daily until...