Rezolute announced on January 23 (U.S. time) that the independent Data Monitoring Committee (DMC) has recommended continuing the Phase 3 sunRIZE study of RZ358 (ersodetug) for patients with congenital hyperinsulinism (HI) as planned, without increasing the number of participants.

The interim analysis of the Phase 3 sunRIZE study was conducted by the DMC in an unblinded state. The analysis evaluated pre-specified primary endpoints (hypoglycemia events) in approximately half of the enrolled patients who had completed key assessments. The purpose of the interim analysis was to assess study futility and confirm the sample size to ensure statistical robustness of the final analysis. The process was conducted independently by the DMC, and the company had no involvement until the results were announced.

Brian Roberts, M.D., Chief Medical Officer of Rezolute, stated: “We are very pleased with the positive recommendation from the Data Monitoring Committee. This validates our initial assumptions regarding the design and scale of the Phase 3 sunRIZE study. While the company remains blinded to partial study data and cannot access the statistical outcomes, we view this recommendation very positively in light of the Phase 2 RIZE study results.”

He added: “The sunRIZE study is progressing smoothly, with patient enrollment ongoing in the U.S. as part of the global trial. We expect enrollment to be completed next month and anticipate announcing topline data for the sunRIZE study in December. Ersodetug has the potential to become a best-in-class therapy for patients living with hyperinsulinism.”

The Phase 3 sunRIZE study is a global trial conducted in more than 12 countries to evaluate the efficacy and safety of ersodetug in patients with congenital hyperinsulinism.

Rezolute is a U.S.-based biotech company developing targeted therapies for rare metabolic diseases, including RZ358 for hyperinsulinism and RZ402, an oral therapy for diabetic macular edema. RZ358 is currently in Phase 3 trials for two indications: congenital hyperinsulinism and tumor-mediated hyperinsulinism. Handok holds commercialization rights for RZ358 and RZ402 in Korea and continues to collaborate with Rezolute throughout the development process.