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Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics Announce CUTX-101, Copper Histidinate, Data to be Presented at 2022 American College of Medical Genetics Annual Clinical Genetics Meeting
Cyprium Therapeutics, a subsidiry of Fortress Biotech, is developing CUTX-101 for the treatment of Menkes disease CUTX-101 has potential to be first
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Cyprium Therapeutics, a subsidiry of Fortress Biotech, is developing CUTX-101 for the treatment of Menkes disease CUTX-101 has potential to be first FDA-approved treatment for Menkes disease; rolling submission of New Drug Application to FDA is ongoing and expected to be completed in mid-year 2022 MIAMI and SOLANA BEACH, Calif., March 21, 2022 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary, with support from its licensing partner Sentynl Therapeutics, Inc. (“Sentynl”), a wholly owned subsidiary of Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), today announced positive data on CUTX-101, copper histidinate (CuHis), in patients with Menkes disease. The data will be presented as a “Top-Rated Abstract” and Poster at the 2022 American College of Medical Genetics and Genomics (“ACMG”) Annual Clinical Genetics Meeting taking place March 22-26, 2022, virtually and at Music City Center in Nashville, TN. The previously reported results are from an efficacy and safety analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101. Details of the poster are as follows: Poster Title: Safety and Efficacy of Copper Histidinate (CUTX-101) Treatment for Menkes Disease Caused by Severe Loss-of-Function Variants in ATP7APoster Number: eP195Authors: 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.Dates / Times: Posters will be available for viewing on Wednesday, March 23, 5:00 p.m. – 7:00 p.m., Thursday, March 24, 9:30 a.m. - 4:30 p.m. and Friday, March 25, 10:00 a.m. – 1:00 p.m. in the Exhibit Hall. Dr. Kaler will formally present the poster on Thursday, March 24 from 10:00 a.m. – 11:30 a.m. CT. The abstract can be viewed here. “The positive data that will be presented at the 2022 ACMG Annual Clinical Genetics Meeting demonstrate the efficacy and safety of CUTX-101 and its potential to be the first treatment approved by the U.S. Food and Drug Administration (“FDA”) for patients with Menkes disease. We continue to make progress with our rolling submission of a new drug application (“NDA”) for CUTX-101 which we anticipate to be completed in the middle of this year,” said Lung S. Yam, M.D., Ph.D., President and Chief Executive Off...