- Rezolute (RZLT, Financial) will present Phase 3 sunRIZE study baseline data at ENDO 2025 on July 14, 2025.
- Topline data expected in December 2025, advancing potential treatment for congenital hyperinsulinism.
- Study enrollment complete, assessing ersodetug's efficacy and safety in treating hypoglycemia.
Rezolute, Inc. (RZLT), a leading biotechnology company specializing in rare disease treatments, announced its forthcoming presentation at the Annual Meeting of the Endocrine Society (ENDO 2025). The presentation will showcase preliminary patient demographics and baseline characteristics from the fully enrolled Phase 3 sunRIZE study of their developmental therapy, ersodetug, designed to treat congenital hyperinsulinism (HI). This event is scheduled to occur on July 14, 2025, during the Pediatric and Adolescent Endocrinology session in San Francisco, CA.
Ersodetug is a novel treatment that functions by allosterically binding to the insulin receptor, alleviating hyperinsulinism-induced hypoglycemia. The sunRIZE study (RZ358-301) is a multi-center, randomized, double-blind, placebo-controlled trial assessing the drug's efficacy in patients aged 3 months to 45 years who suffer from persistent hypoglycemia despite standard of care (SOC) treatment.
The study included approximately 56 participants across various countries, surpassing enrollment expectations. With the recruitment phase complete, the company anticipates reporting topline data in December 2025, marking a significant step toward offering a new therapeutic option for patients with limited alternatives.
Rezolute's Chief Medical Officer, Dr. Brian Roberts, will emphasize the study's alignment with the Phase 2 RIZE study population, underscoring ongoing unmet medical needs in this patient demographic.
For more information on Rezolute and its groundbreaking work in tackling congenital hyperinsulinism, visit their official website.
