Shots:
- Novartis has reported data from the biomarker cohort of the P-I/II (FORTITUDE) study assessing delpacibart braxlosiran (2mg/kg, Q6W) vs PBO in 90 pts (16-70yrs.) with facioscapulohumeral muscular dystrophy (FSHD)
- Trial met its 1 & key 2EPs, showing reductions in KHDC1L (cDUX) & creatine kinase biomarker levels, which indicates potent target engagement & decrease in muscle damage in pts with FSHD
- del-brax is also being assessed in the P-III (FORTITUDE-3) trial against PBO in ~200 pts (16-70yrs.) with FSHD to evaluate quantitative muscle testing (in US) & 10-meter walk/run test (in EU) as the 1EP
Ref: Globenewswire | Image: Novartis | Press Release
Related News: Novartis Reports Topline P-III (RemIND) Trial Results on Remibrutinib in Chronic Inducible Urticaria (CIndU)
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