Sanofi Report Results of Avalglucosidase alfa in P-III COMET Study for Late Onset Pompe Disease
Sanofi Terminates its Four Years Alliance with Lexicon for Zynquista (sotagliflozin)
Shots:
- The P-III COMET study involves assessing avalglucosidase alfa (20 mg/kg) vs alglucosidase alfa (SOC, 20 mg/kg) IV infusion q2w for 49 wks. After 49 wks., patients previously receiving SOC switched to avalglucosidase alfa for the ongoing open-label treatment portion of the study
- Results: met its 1EPs i.e. demonstrating non-inferiority in improving respiratory function, FVC (% predicted) (2.89 vs 0.46); 2EPs is measured mobility with the 6-minute walk test (6MWT) (32.21 vs 2.19 mts.); pre-specified preliminary analysis evaluating percent-predicted FVC and 6MWT in those patients who switched (switch patients)@49 wks. for the OLE period of the trial showed 0.15-point improvement in FVC and 23.32-meter improvement in 6MWT
- Avalglucosidase alfa is an investigational ERT for Pompe disease designed to improve the delivery of enzyme to the cells in the muscles and is evaluated in ongoing P-II NEO-EXT study in patients with LOPD for a duration of up to ~ 8 yrs. in patients from the P-I /II NEO1 study. The regulatory submissions to be anticipated in H2’20
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