Cyprium Therapeutics, Inc. and Sentynl Therapeutics, Inc., a U.S.-based specialty pharma company owned by the Zydus Group, executed an agreement to acquire Cyprium’s rights to CUTX-101, its Copper Histidinate product candidate for the treatment of Menkes disease.

Sentynl will pay $20 million in upfront and regulatory milestones through NDA approval, as well as potential sales milestones plus royalties based on CUTX-101 sales. Cyprium will be responsible for development of CUTX-101 through approval by the FDA, and Sentynl will be responsible for commercialization of CUTX-101 as well as progressing newborn screening activities. Continued development of CUTX-101 will be overseen by a Joint Steering Committee consisting of representatives from Cyprium and Sentynl.

“We are very pleased to partner with Sentynl to potentially expedite the development and commercialization of CUTX-101. The drug has demonstrated a compelling safety and efficacy profile in topline analysis for the treatment of Menkes disease. We look forward to working with Sentynl to begin the rolling submission of the NDA to the FDA this year. If approved, CUTX-101 will provide a major breakthrough and fill a significant unmet need for children suffering from this rare, fatal pediatric disease,” said Lung S. Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium.

Matt Heck, Co-founder, President & Chief Executive Officer of Sentynl, said, “Our mission, at the Zydus Group, has been to provide healthcare professionals with access to innovative treatment solutions that enable them to meet the needs of individual patients. We are excited to collaborate with Cyprium in order to broaden our pediatric rare disease portfolio and commercialize CUTX-101, a potentially transformative product, for children with Menkes disease, an unmet healthcare need.

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of copper transporter ATP7A. The condition is characterized by distinctive clinical features, including sparse and depigmented hair, connective tissue problems, and severe neurological symptoms such as seizures, hypotonia, failure to thrive, and neurodevelopmental delays.