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 90% to $1.06 in premarket 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 can lead to brain damage if not properly managed.
The trial, which enrolled 63 patients, failed to meet its main goal of a reduction in weekly low-blood-sugar events.
Patients on the highest dose 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.
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 episodes in patients, using continuous monitoring devices.
Ersodetug is an antibody therapy designed to block excessive insulin activity by targeting insulin receptors to stabilize blood sugar levels.
Rezolute said the drug was generally safe, though two patients had serious allergic reactions during the trial and stopped treatment.
“We are disappointed that the study did not demonstrate significant improvements,” said Chief Medical Officer Brian Roberts.
The company has 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 ongoing, with results expected in the second half of 2026.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Sriraj Kalluvila and Shinjini Ganguli)
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