The P-II (Mini-COMET) trial evaluates the safety & efficacy of Nexviazyme (20/40mg/kg, Q2W) in patients (n=22; under 18yrs. old) with IOPD previously treated for ≥6mos. showing a clinical decline (Cohorts 1 & 2) or suboptimal response (Cohort 3)
Sanofi also presented safety results from the P-III (Baby-COMET) trial evaluating the safety & efficacy of Nexviazyme in IOPD treatment-naïve patients & the 8yrs. follow up data from the P-II/III (NEO-EXT) study evaluating safety, tolerability, PK, PD & exploratory efficacy of Nexviazyme in LOPD patients
The results depicted the clinical safety, benefit & durability of Nexviazyme across a wide-range of Pompe disease patient groups. Results expected to be presented at the WORLDSymposium 2024
Ref: Globe Newswire | Image: Medcity News
Related Post:- Sanofi’s Nexviazyme (avalglucosidase alfa-ngpt) Receives the US FDA’s Approval for the Treatment of Late-Onset Pompe Disease
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