Fourth and final module of the PMA submitted in June
Supportive analyses included in final module of the PMA meet both of the pre-specified co-primary endpoints in the AUDACITY Study
Allurion Technologies, Inc. (NYSE: ALUR), a pioneer in metabolically healthy weight loss, today announced submission of the fourth and final module of the Pre-Market Approval (PMA) application to the Food & Drug Administration (FDA) and additional, supportive analyses from the AUDACITY Study that meet both of the pre-specified co-primary endpoints.
Topline results announced previously showed that the AUDACITY Study met its first co-primary endpoint related to responder rate at 48 weeks. Allurion Balloon subjects also exhibited substantially greater weight loss compared to control subjects at 48 weeks, with a mean difference in total body weight loss of 3.77%, resulting in a 2.69% super-superiority margin. This margin was less than the pre-specified 3% super-superiority margin needed to meet the comparative co-primary endpoint and was impacted, in part, by higher-than-expected weight loss in control subjects.
Additional analyses submitted in the PMA application were conducted to account for the results seen in the control group. Using imputation methods that account for the variations observed in the control subjects, the mean difference in weight loss between the treatment and control groups at 48 weeks was 4.34% with a super-superiority margin of 3.14%, exceeding the pre-specified 3% super-superiority margin in the second co-primary endpoint (p = .0142).
At 40 weeks, using these imputation methods, the mean difference in weight loss between the treatment and control groups was 4.90% with a super-superiority margin of 3.75%, considerably exceeding the pre-specified margin in the second co-primary endpoint (p = .0006).
“We are thrilled to submit our PMA on schedule with additional analyses that support the effectiveness of the Allurion Balloon,” said Dr. Shantanu Gaur, Founder and CEO of Allurion. “We believe that these analyses are more suitable for the trends observed in both groups in the AUDACITY Study and further strengthen our positive topline data. With the PMA now submitted, we are looking forward to working with the FDA toward an approval.”
The AUDACITY Study is an open-label, multicenter, randomized, controlled study and is the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. 550 subjects were randomized 1:1 to either two cycles of the Allurion Balloon1 or a control group that received moderate intensity lifestyle therapy. Subjects in the treatment group received their first Allurion Balloon at Week 0, which passes at approximately Week 16, and a second Allurion Balloon at Week 24, which passes at approximately Week 40. Co-primary endpoints based on Allurion Balloon subject responders and a comparison of percent total body weight loss between groups were measured at Week 48, approximately eight weeks after the second Allurion Balloon passes at Week 40.
