Zydus Group’s Sentynl Therapeutics gains full control of Menkes Disease candidate CUTX-101

Sentynl Therapeutics, Inc., a U.S.-based biopharmaceutical company under Zydus Lifesciences, Ltd., has finalized an agreement with Cyprium Therapeutics, Inc., a subsidiary of Fortress Biotech, Inc. The deal involves the transfer of worldwide proprietary rights and U.S. FDA documents for CUTX-101, a promising product candidate for Menkes disease treatment. With this agreement, Sentynl assumes full responsibility for the development and commercialization of CUTX-101.

Promising Clinical Developments of CUTX-101

Sentynl’s acquisition of CUTX-101, a copper histidinate product candidate, follows positive results from safety and efficacy analyses of two pivotal studies. The ongoing rolling submission of the New Drug Application (NDA) to the FDA is expected to complete in 2024. CUTX-101 has shown significant potential in early treatment, leading to improvements in neurodevelopmental outcomes and survival in patients with Menkes disease.

Impact and Hope for Menkes Disease Patients and Families

Menkes disease, a rare genetic disorder, profoundly impacts patients and caregivers, with most patients succumbing to the disease between 6 months and 3 years of age. The development of CUTX-101 represents a beacon of hope for affected families. Drew and Jamie Eckman, founders of the Menkes Foundation, have expressed optimism about the future treatment prospects for this condition.

Future Prospects of CUTX-101 Under Sentynl’s Stewardship

Under Sentynl’s leadership, CUTX-101 is poised to become the first FDA-approved treatment for Menkes disease. The drug has been granted FDA Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug Designations. Additionally, the European Medicines Agency has granted Orphan Designation to CUTX-101. Sentynl’s management of an expanded access protocol for Menkes disease at multiple U.S. medical centers signifies its commitment to addressing this rare pediatric condition.