Handok Partner Rezolute to Seek FDA Pre-BLA Meeting for Ersodetug in Congenital Hyperinsulinism

[Financial News] Handok’s open-innovation partner Rezolute is preparing the U.S. approval process for ersodetug (RZ358), which is being developed as a treatment for congenital hyperinsulinism.
Rezolute said on the 5th (local time) that the U.S. Food and Drug Administration (FDA) recommended that it request a pre-biologics license application (pre-BLA) meeting for ersodetug. The FDA made the recommendation after reviewing additional analyses from the global Phase 3 sunRIZE study in congenital hyperinsulinism.
The sunRIZE study evaluated the efficacy and safety of ersodetug in patients with congenital hyperinsulinism. Although an overall improvement in blood glucose was observed, the primary endpoint was not met because the reduction in hypoglycemia, based on self-monitored blood glucose (SMBG), was not statistically significant compared with placebo. The key secondary endpoint using continuous glucose monitoring (CGM) also failed to meet the threshold at week 24.
However, improvements with treatment were observed across several hypoglycemia-related measures using CGM. At a meeting this past March, the FDA requested that CGM data be submitted separately for review, taking into account the characteristics of the congenital hyperinsulinism patient population and the limitations of existing methods for assessing hypoglycemia.
In response, Rezolute submitted clinical raw data and analyzed data, as well as the results of prespecified and post hoc analyses and sensitivity analyses, to the FDA this past June. After reviewing the materials, the FDA recommended a pre-BLA meeting.
The recommendation does not mean that ersodetug is likely to be approved. The FDA said that its decision on approval would be made after a comprehensive review of all the data during the future BLA review process.
Rezolute is also conducting another Phase 3 trial, upLIFT, in patients whose insulin is excessively secreted due to tumors. The company said that, among the eight patients enrolled to date, seven met the prespecified treatment response criteria. Rezolute plans to announce key upLIFT results in the fourth quarter of this year and then consider a BLA submission strategy covering both indications.
Congenital hyperinsulinism is a rare disease in which excessive insulin secretion causes recurrent episodes of severe hypoglycemia. Ersodetug is a fully human monoclonal antibody that selectively binds to the insulin receptor. It is being developed to reduce hypoglycemia by modulating excessive insulin activity.
Meanwhile, Handok has invested in Rezolute and holds an equity stake in the company, and has secured the domestic commercialization rights to ersodetug.
[email protected] Jung Sang-hee Reporter