Zydus Lifesciences and Fortress Biotech subsidiaries announce positive data on CUTX-101in patients with Menkes disease

22 Mar 2022 , 02:15 PM

Cyprium Therapeutics, Inc., a Fortress Biotech, Inc., subsidiary, with support from its licensing partner Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), on Monday 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.

“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 Officer of Cyprium. “We welcome the opportunity to present the positive efficacy and safety data of CUTX-101 to medical geneticists who are often involved in the diagnosis and treatment of Menkes disease, a rare, fatal pediatric disease.”

In 2021, Cyprium partnered with Sentynl Therapeutics, Inc., a U.S.-based specialty pharmaceutical company owned by the Zydus Group, to bring CUTX-101 to market. Cyprium will retain development responsibility of CUTX-101 through approval of the NDA by the FDA, and Sentynl will be responsible for commercialization of CUTX-101 as well as progressing newborn screening activities.

Zydus’ wholly-owned subsidiary Sentynl Therapeutics is focused on empowering patients suffering from rare diseases. The positive data on CUTX-101, copper histidinate (CuHis) is a positive step in this direction. The group company recently entered into an asset purchase agreement for the purchase of BridgeBio’s NULIBRYâ„¢ (Fosdenopterin) for Injection to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultrarare, life-threatening pediatric genetic disorder.

At around 2.19 pm, Zydus Lifesciences Ltd was trading at Rs361 per piece down by Rs5.6 or 1.53% from its previous closing of Rs366.60 per piece on the BSE.