Rezolute completes enrollment in phase 3 tumor study

Rezolute Inc., a company listed on NASDAQ under the ticker RZLT, has reported that its Phase 3 study of ersodetug for tumor hyperinsulinism has reached full enrollment. The anticipated release of preliminary results is expected in mid-December 2026, according to the company's press release. The clinical trial, known as the upLIFT study, included 16 patients with insulinoma or non-islet cell tumors experiencing uncontrolled hypoglycemia due to tumor hyperinsulinism.

The primary objective of the study is to determine the percentage of participants who, during the treatment phase, experience at least a 50% reduction in glucose infusion rate from baseline, as measured by intravenous glucose. To reach statistical significance, the lower bound of the 95% confidence interval for the responder rate must be at least 30%, which equates to a response rate of at least 56% for the 16 participants.

As of earlier this year, seven of the first eight enrolled patients met the responder criterion. Each of these seven patients discontinued the use of intravenous glucose following ersodetug administration. The eighth participant opted for hospice care shortly after enrollment and unfortunately passed away a week later due to cancer progression; this individual is considered a non-responder for the primary endpoint.

The company noted that ersodetug has been well-tolerated in the study, with no reported drug-related safety issues thus far. The company plans to maintain an expanded access program to provide ersodetug through compassionate use to individuals suffering from serious and refractory hypoglycemia caused by tumor hyperinsulinism. Tumor hyperinsulinism occurs as a result of islet cell tumors or non-islet cell tumors, both of which lead to hypoglycemia through the over-activation of the insulin receptor.

Insulinomas produce hypoglycemia by stimulating excessive insulin production, while non-islet cell tumors can generate insulin-like paraneoplastic substances. Ersodetug, a fully human monoclonal antibody, targets the insulin receptor to mitigate receptor over-activation in hyperinsulinism conditions. It is essential to note that ersodetug remains an investigational treatment and has not received approval from any health authority.