BASEL (dpa-AFX) - Novartis AG (NVS) on Thursday reported positive results from the biomarker cohort of the FORTITUDE Phase I/II study evaluating del-brax in patients with Facioscapulohumeral Muscular Dystrophy (FSHD).
The FORTITUDE Phase I/II trial is assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of del-brax in FSHD patients.
Cohort C of the study evaluated del-brax administered every six weeks versus placebo over a 12-month period in patients aged 16 to 70 years. The study met its primary and key secondary endpoints, demonstrating reductions in KHDC1L and creatine kinase levels, while maintaining a safety profile consistent with previous findings.
The Phase III FORTITUDE-3 study of del-brax is currently underway.
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