By Kamal Choudhury Dec 11 (Reuters) – Rezolute said on Thursday its therapy aimed at controlling excessive insulin activity in patients with a rare genetic disorder did not show significant benefit in a late-stage trial. Shares of the Redwood City-based company fell 89% to $1.15 in morning trading. The therapy, called ersodetug, was tested in […]
Health
Rezolute’s rare disease drug fails to reduce low-blood sugar episodes in trial
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By Kamal Choudhury
Dec 11 (Reuters) – Rezolute said on Thursday its therapy aimed at controlling excessive insulin activity in patients with a rare genetic disorder did not show significant benefit in a late-stage trial.
Shares of the Redwood City-based company fell 89% to $1.15 in morning trading.
The therapy, called ersodetug, was tested in patients with congenital hyperinsulinism, a condition where the body produces too much insulin and causes severe episodes of low blood sugar. The disease primarily affects children and could lead to brain damage.
The trial had enrolled 63 patients, aged between 3 months and 45 years.
Patients on the highest dose of the drug saw a 45% reduction in the weekly episodes of low blood sugar, but that was not statistically better than the placebo group, which recorded a 40% improvement.
CEO Nevan Elam blamed the large placebo response on “an inherent problem” in conducting trials in ultra-rare pediatric populations where families closely monitored glucose levels.
The study also failed to show a significant benefit in a key secondary measure that tracked the change in the average time of low blood sugar events in patients.
“Ersodetug’s efficacy fell short, and the placebo effect was also higher than expected,” Wedbush analyst Yun Zhong said.
Despite the setback, more than 50 children from the trial continue taking the drug in an extension study, with some weaned off other background therapies, the company said.
The antibody therapy is designed to block excessive insulin activity by targeting insulin receptors to stabilize blood sugar levels.
The Redwood City-based company plans to meet with the U.S. Food and Drug Administration to discuss the next steps.
Rezolute’s other late-stage trial, testing the drug in patients with tumor-related hyperinsulinism, is underway, with results expected in the second half of 2026.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Sriraj Kalluvila and Shinjini Ganguli)