The trial will enrol congenital HI patients aged three months to 45 years who suffer from poorly controlled hypoglycaemia. Credit: PeopleImages.com – Yuri A / Shutterstock.

The US Food and Drug Administration (FDA) has lifted the partial clinical holds preventing Rezolute’s RZ358 (ersodetug) from being investigated in a Phase III trial for treating hypoglycaemia caused by congenital hyperinsulinism (HI).

This regulatory decision will help the company include US participants in the ongoing global sunRIZE study.

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The randomised, placebo-controlled parallel arm will assess ersodetug’s safety and efficacy at multiple trial sites.

The trial aims to enrol up to 56 individuals aged three months to 45 years with congenital HI who suffer from poorly controlled hypoglycaemia.

Following the FDA’s decision, Rezolute is set to begin study commencement works activities in the US before enrolling US participants in the sunRIZE study.

The company aims to begin enrolling these participants early next year, with topline data from the study expected in the second half of the year.

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Ersodetug is a fully human monoclonal antibody that targets insulin receptors to mitigate the effects of over-activation by insulin and substances such as IGF-2.

Because the drug operates downstream from the pancreas, it is thought to be able to effectively treat hypoglycaemia caused by any form of HI.

In its decision, the FDA stated that although liver toxicity was observed in Sprague Dawley rats that were given ersodetug in preclinical studies, this was likely strain-specific and not relevant to humans.

Rezolute CEO and founder Nevan Charles Elam said: “We are delighted that the FDA has completely removed the partial clinical holds and is allowing us to proceed in the US at all doses and in participants as young as three months of age as part of our ongoing global study.

“Coming on the heels of our recent announcement of FDA clearance of a separate Phase II study in tumour-associated HI, we are in the unique and fortunate position to be advancing ersodetug in two Phase III rare disease programmes in the US and globally.”