Benzinga | Oct 8, 2021 01:19PM EDT

Fortress-Backed Cyprium's Formulated Copper Histidinate Shows Efficacy In Rare Pediatric Disease

* Fortress Biotech Inc's (NASDAQ:FBIO) partner company, Cyprium Therapeutics Inc announced results from an efficacy and safety analysis of data integrated from two CUTX-101 studies in 129 Menkes disease patients.

* In both pre-specified primary and secondary efficacy analyses, treatment with CUTX-101 demonstrated a significantly greater median overall survival (OS) than untreated historical control patients.

* The data will be presented at the 2021 American Academy of Pediatrics National Conference & Exhibition.

* CUTX-101 is a subcutaneous injectable formulation of Copper Histidinate (CuHis).

* In the early treatment cohort, a 79% reduction in risk of death was observed in CuHis-ET patients compared with historical control HC-ET patients. The median OS was 177.1 and 16.1 months, respectively, with a hazard ratio (HR).

* A 75% reduction in the risk of death was also observed in CuHis-LT (late treatment) patients compared with HC-LT subjects, and median OS was 62.4 and 17.6 months, respectively.

* CUTX-101 was shown to be well tolerated. In CuHis-ET and CuHis-LT cohorts, the most common treatment-emergent adverse events were pneumonia (30.3%), seizures (21.2%), dehydration (18.2%), failure to thrive (16.7%), and respiratory distress (15.2%).

* No patient discontinued due to an adverse event considered related to treatment.

* Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of copper transporter ATP7A.

* Price Action: FBIO shares are up 0.34% at $2.95 during the market session on the last check Friday.