Zydus Lifesciences US arm concludes asset transfer of CUTX-101 for Menkes disease from Cyprium Therapeutics

Ahmedabad: Sentynl Therapeutics, Inc., a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (Zydus Group), today announced the execution of an Assignment and Assumption Agreement with Cyprium Therapeutics, Inc., a Fortress Biotech, Inc. subsidiary company.

Under the agreement, Cyprium completed the transfer of its worldwide proprietary rights and U.S. FDA documents pertaining to CUTX-101, the copper histidinate product candidate for the treatment of Menkes disease, to Sentynl.

Sentynl now assumes full responsibility for the development and commercialization of CUTX-101.

In 2021, Sentynl and Cyprium reported positive results from a safety and efficacy analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101. A rolling submission of the CUTX-101 New Drug Application (NDA) to the FDA is ongoing, with expected completion in 2024.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences said, “We have been committed to providing access to path-breaking discoveries that can bridge unmet healthcare needs, globally. The rights for CUTX-101 is a significant milestone towards our vision to transform lives and meaningfully impact patients, healthcare providers and the rare disease community at large. This novel, breakthrough therapy could unlock possibilities for the treatment of the life threatening Menkes disease.”

“Menkes disease has a devastating impact on patients and their caregivers. With no current approved treatments, death usually occurs between 6 months and 3 years old,” said Matt Heck, President & Chief Executive Officer of Sentynl. “We are committed to advancing CUTX-101, which has the potential to not only become the first FDA-approved treatment for Menkes disease, but also positively impact the lives of the patients and their caregivers affected by this rare, fatal condition.”

“We know first-hand the difficult journey that patients and families of Menkes disease face,” commented Drew and Jamie Eckman, Founders of the Menkes Foundation and parents of Wesley, who was diagnosed with Menkes disease at 8.5 months old and passed away three months later. “The development of CUTX101 represents incredible progress in the fight against Menkes disease. We hold a strong amount of hope for a time when there is an option available to treat this condition, providing a path forward for caregivers and their children.”

Read also: Zydus Lifesciences gets USFDA nod for heart failure drug Ivabradine