Rezolute provided insights from the Phase 3 sunRIZE study in patients with congenital HI and detailed the treatment of tumor HI patients with ersodetug under the Company's EAP.
Results exhibited evidence of pharmacologic activity and reductions in events and time in hypoglycemia.
The study highlighted challenges in monitoring glucose levels in an ambulatory setting, attributed to factors like intensive monitoring.
Evidence of Pharmacologic Activity
Target therapeutic drug concentrations were achieved in treatment groups, with biomarker responses indicating reduced insulin activity.
Challenges in Hypoglycemia Study
The study noted a pronounced placebo effect and encountered difficulties in assessing hypoglycemia reduction.
Importance of Ongoing Extension Study
The open-label extension revealed potential benefits of ersodetug, with some patients transitioning to monotherapy.
Upcoming FDA Interaction
Rezolute plans to collaborate with the FDA in Q1 2026 under Breakthrough Therapy Designation to review clinical outcomes.
- Rezolute believes data from sunRIZE and the EAP offer evidence of ersodetug's efficacy in treating congenital and tumor hyperinsulinism.
- Challenges in the study underscore the intricacies of evaluating hypoglycemia reduction in clinical trials.
- Insights gained from the study will shape future strategies in comprehending the clinical efficacy of ersodetug.
Rezolute's Phase 3 sunRIZE study and EAP findings provide valuable insights into hyperinsulinism treatment. The company's ongoing research and FDA engagement signify its dedication to advancing therapies for rare diseases.