Rezolute's rare disease drug fails to meet main goal in late-stage trial
Rezolute's experimental drug for congenital hyperinsulinism failed to show statistically significant improvement over placebo in a late-stage trial, with two patients experiencing serious allergic reactions.
Insights:
Rezolute said on Thursday its experimental drug for a rare genetic condition that causes dangerously low blood sugar failed to meet the main goal in a late-stage study. The drug, ersodetug, was being tested in patients with congenital hyperinsulinism.
The trial showed a 45% drop in weekly hypoglycemia events at the highest dose, but that was not statistically better than the placebo group, which saw a 40% improvement. The lack of statistical significance means the drug failed to demonstrate a clear therapeutic benefit over placebo despite the numerical difference.
