Rezolute’s Phase 3 sunRIZE Study for Ersodetug Fails to Meet Primary and Secondary Endpoints Despite Analyst Backing

Rezolute Inc. (NASDAQ:RZLT) is one of the best biotech penny stocks to buy according to analysts. On December 11, Rezolute released topline results from its Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism/HI. The study, which included 63 participants aged 3 months to 45 years across more than a dozen countries, did not meet its primary or key secondary endpoints.

The primary endpoint of the study focused on the change in average weekly hypoglycemia events measured via self-monitored blood glucose. While the top dose of 10 mg/kg led to a ~45% reduction in these events, the result was not statistically significant compared to the 40% improvement observed in the placebo group. Similarly, the key secondary endpoint, the change in average daily percent time in hypoglycemia, showed a 25% reduction at the 10 mg/kg dose compared to a ~5% increase in the placebo arm, which also failed to reach statistical significance.

Despite missing the efficacy targets, the drug reached target concentrations across all age groups using a dosing regimen of 5 and 10 mg/kg every other week for three doses, followed by monthly administration. Safety observations were described as generally favorable. Two participants experienced serious hypersensitivity reactions that led to early discontinuation, though Rezolute Inc. (NASDAQ:RZLT) noted that the incidence of such reactions remains low compared to other biologic treatments. The most common adverse event was hypertrichosis (excessive hair growth), which was mild and self-limiting.

Rezolute Inc. (NASDAQ:RZLT) is a late-stage rare disease company that improves outcomes for individuals with hypoglycemia caused by hyperinsulinism in the US.

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Disclosure: None. This article is originally published at Insider Monkey.