Sanofi presents new Phase 3 data on Nexviazyme at WORLDSymposium

Sanofi announces data from the Phase 3 COMET study long-term extension showed sustained treatment effect of Nexviazyme over nearly three years in late-onset Pompe disease patients who were treatment-naive as well as those who switched from long-time standard of care, alglucosidase alfa, during the 96-week extension period. Additionally, a separate analysis of respiratory function showed clinical benefit over two years for patients who switched to Nexviazyme regardless of prior response to alglucosidase alfa. This was presented at the WORLDSymposium. Nexviazyme is a monotherapy approved in the US and other markets for the treatment of LOPD. It is also approved for infantile-onset Pompe disease in certain markets outside of the US. Nexviazyme maintained treatment effect at 145 weeks: The Phase 3 COMET trial enrolled 100 previously untreated LOPD patients who were randomized to receive either Nexviazyme or alglucosidase alfa every two weeks for 49 weeks. After nearly three years, changes from baseline showed: Patients who received continuous Nexviazyme treatment for 145 weeks experienced sustained improvements in respiratory and motor function, showing a 1.40 point improvement in forced vital capacity percent-predicted and an average increase of 20.65 meters in walking distance as measured by the six-minute walk test, respectively, compared to baseline. Patients who switched from alglucosidase alfa to Nexviazyme treatment during the extension period experienced stabilization of treatment effect, showing a 1.18 point improvement in FVC percent-predicted and an average increase of 0.29 meters in walking distance, compared to baseline. The safety profile during treatment with Nexviazyme was comparable between both study groups. No new safety signals were observed in patients who switched from alglucosidase alfa to Nexviazyme during the extension period. Clinical benefits seen over two years for patients who switched to Nexviazyme: Findings showed clinical benefits over two years following switch to Nexviazyme regardless of prior response to alglucosidase alfa: Patients who responded to alglucosidase alfa treatment in the primary analysis period had increased respiratory function, which was maintained throughout the extension period with Nexviazyme treatment. Patients who did not respond to alglucosidase alfa treatment in the primary analysis period had reduced respiratory function while taking alglucosidase alfa; however, switching to Nexviazyme halted this decline in the extension period.