Copper Histidinate data to be presented at 2022 American College of Medical Genetics Annual Clinical Genetics Meeting  

Cyprium Therapeutics, a Fortress Biotech subsidiary, with support from its licensing partner Sentynl Therapeutics, a wholly-owned subsidiary of Zydus Lifesciences, yesterday 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 from 22nd to 26th March, 2022, virtually. 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 companies said in a joint statement.

“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 US 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, MD, PhD, President and Chief Executive Officer, Cyprium, in the statement.

In 2021, Cyprium partnered with Sentynl Therapeutics 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 commercialisation of CUTX-101 as well as progressing new-born screening activities, the statement noted.