Rezolute's ersodetug Phase 3 sunRIZE misses primary endpoint in congenital hyperinsulinism; FDA review continues
核心洞察
Rezolute said the FDA is continuing to review additional Phase 3 sunRIZE data for ersodetug in congenital hyperinsulinism (搜索) after the trial missed its primary endpoint.
The 63-patient study tested two ersodetug doses against placebo, and the company reported consistent CGM improvements including 50% or greater reductions in hypoglycemia metrics.
No timeline for FDA feedback has been set, while topline results from the Phase 3 upLIFT study in tumor hyperinsulinism (搜索) are expected before the end of 2026.
Rezolute (NASDAQ:RZLT) said the FDA is continuing its review of additional Phase 3 sunRIZE data for ersodetug in congenital hyperinsulinism (搜索) after the study failed to meet its primary endpoint, leaving the potential regulatory path unresolved and without a specific timeline for agency feedback.
The 63-patient sunRIZE study evaluated two doses of ersodetug against placebo. Hypoglycemia events declined from baseline, but the primary endpoint did not show a statistically significant improvement versus placebo, and key secondary endpoints were also missed. After a Type B meeting in March 2026, the FDA requested additional study information for an independent review; Rezolute submitted source and analysis datasets in June along with pre-specified, post-hoc and sensitivity analyses focused particularly on continuous glucose monitoring (CGM). According to the company, both dose groups showed consistent glycemic improvements versus placebo across multiple CGM measures, including reductions of at least 50% in average daily percentage of time spent in hypoglycemia and average weekly hypoglycemia events.
The FDA has reiterated that its review is continuing as it considers a potential regulatory path forward, but Rezolute said there is no specific timetable for feedback or agreement on next steps, since the review is occurring outside the customary formal meeting process. The company retains the option of requesting a formal FDA meeting under an established regulatory timeline. An ongoing open-label extension has accumulated approximately nine months to more than two years of ersodetug treatment, with high retention, continued glycemic monitoring and reduced use of background standard-of-care therapies. Separately, the Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism (搜索) continues to recruit patients, with topline results targeted before the end of 2026.
Source: Yahoo Finance