Monday, the FDA removed partial clinical holds on Rezolute, Inc.’s RZ358 (ersodetug), a potential treatment for hypoglycemia (low blood sugar) caused by congenital hyperinsulinism (HI).

Congenital HI is a genetic disorder in which the insulin cells of the pancreas, called beta cells, secrete too much insulin.

Also Read: Why Is Small-Cap Metabolic-Focused Rezolute Stock Trading Higher On Wednesday?

Ersodetug is currently being studied in sunRIZE, a global Phase 3, multi-center, double-blind, randomized, placebo-controlled, safety and efficacy registrational study in participants with congenital HI.

The company will now commence study start-up activities in the U.S. with the goal of including U.S. participants in the global sunRIZE study.

The company anticipates potential U.S. enrollment to begin in early 2025, which will enable announcement of topline data from the study in the second half of 2025.

“We are delighted that FDA has completely removed the partial clinical holds and are allowing us to proceed in the U.S. at all doses and in participants as young as three months of age as part of our ongoing global study. Of note, FDA specifically concluded that the liver toxicity observed in Sprague Dawley rats is likely strain-specific and not otherwise relevant to humans,” said Nevan Charles Elam, CEO and Founder of Rezolute ( RZLT ).

“Coming on the heels of our recent announcement of FDA clearance of a separate Phase 3 study in tumor-associated HI, we are in the unique and fortunate position to be advancing ersodetug in two Phase 3 rare disease programs in the U.S. and globally,” Charles Elam added.

Price Action: RZLT stock is up 14.5% at $4.98 at last check Monday.

Image via Shutterstock

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