Rezolute decimated on Phase III miss for ersodetug

US late-stage rare disease focused pharma Rezolute (Nasdaq: RZLT) announced disappointing top-line results from its Phase III sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI), with news sending its shares crashing 87% to $1.40 by close of trading yesterday.

The study did not meet its primary endpoint, which assessed change in the average weekly hypoglycemia events by self-monitored blood glucose. There was an approximate 45% reduction in hypoglycemia events observed at the top ersodetug dose (10mg/kg), which was not statistically significant compared to the placebo group, which experienced a 40% improvement. Furthermore, the study did not meet its key secondary endpoint, which assessed change in average daily percent time in hypoglycemia by continuous glucose monitoring (CGM). At the 10mg/kg dose of ersodetug, an approximate 25% reduction in time in hypoglycemia was observed, which was not statistically significant compared to the placebo, which increased by approximately 5%.

At the study dose regimens of 5 and 10mg/kg administered every other week for 3 doses, followed by every 4 weeks over the remainder of the 24-week treatment duration, ersodetug target drug concentrations were achieved, across all age groups studied.