Sanofi Report Results of Avalglucosidase alfa in P-III COMET Study for Late Onset Pompe Disease

 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

Click here to read full press release/ article | Ref: Sanofi | Image: Pharmaworld

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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