Rezolute Hits 52-Week High On Ersodetug Progress In UpLIFT And SunRIZE Trials For Hyperinsulinism

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(RTTNews) - Shares of Rezolute Inc. (RZLT) touched a new 52-week high of $8.06 last week amid FDA alignment on a significantly streamlined clinical development path for its lead asset, Ersodetug, in tumor-induced hyperinsulinism, as well as growing anticipation ahead of an upcoming trial catalyst in congenital hyperinsulinism.

Ersodetug is a fully human monoclonal antibody designed to help control blood sugar levels. It works in a unique way by attaching to insulin receptors in the body to reduce the effects of too much insulin or related hormones. It is administered by IV infusion every 2 to 4 weeks.

Last month, the FDA agreed to the changes in the design of the company's ongoing phase III registrational study evaluating Ersodetug for the treatment of hypoglycemia in patients with tumor-associated hyperinsulinism, dubbed upLIFT.

Hypoglycemia is a condition in which blood sugar drops below normal levels. Certain cancers can overstimulate the insulin pathway, producing insulin or substances similar to insulin, called hyperinsulinism, causing blood glucose to fall to dangerously low levels.

Tumor hyperinsulinism may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia. Insulinomas are the most common type of functional ICT and cause hypoglycemia because of the overproduction of insulin. NICTs can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as IGF-2 or related variants that bind to and activate the insulin receptor. This form of hypoglycemia can occur in multiple tumor types, including hepatocellular carcinoma, fibrosarcomas, and mesotheliomas, among others.

The upLIFT study was initially designed as a double-blind, placebo-controlled trial to enroll 48 patients with insulinoma or non-islet cell tumors who have uncontrolled hypoglycemia caused by tumor hyperinsulinism.

However, with the newly approved changes, the study no longer requires a double-blind, randomized, placebo-controlled design. Instead, it will be shortened and limited to a single-arm, open-label format, involving as few as 16 participants.

The company expects to report topline data from the upLIFT study in the second half of 2026.

Ersodetug is also being explored as a treatment for hypoglycemia in patients with congenital hyperinsulinism.

Congenital hyperinsulinism (cHI) is a rare pediatric genetic disorder marked by excessive production of insulin by the pancreas. If left untreated, elevated insulin levels can cause extreme hypoglycemic (low blood sugar) events, increasing the risk of neurologic and developmental complications, including persistent feeding problems, learning disabilities, recurrent seizures, brain damage, or even death.

A global, phase III double-blind, randomized, placebo-controlled, parallel arm study evaluating the efficacy and safety of Ersodetug for the treatment of hypoglycemia in patients with congenital hyperinsulinism, dubbed sunRIZE, is ongoing. The trial is now fully enrolled, with 62 patients taking part - more than the original goal of 56 participants.

The company expects to report topline data from the sunRIZE trial in December of 2025.

Also in the pipeline is RZ402, a selective and potent oral plasma kallikrein inhibitor for the treatment of diabetic macular edema.

Diabetic macular edema (DME) is a severe, systemic, vision-threatening complication of diabetic retinopathy. It is characterized by swelling of the retina and thickening of the macula, the part of the eye that is responsible for high-resolution vision.

A phase II proof-of-concept study of RZ402 in patients with DME was successfully completed last May, and the company is actively seeking a partner to continue development of this program.

When we alerted readers to RZLT on April 1, 2024, it was trading at $2.68. The stock touched a 52-week high of $8.06 during intraday trading on Friday (Sep.5, 2025), before closing at $8.00, up 8.40%.