HanDoc announced on June 4 that its partner, Resolute, presented interim results from the Phase 3 clinical trial of ErsoDetug (RZ358) for patients with tumor-induced hyperinsulinemia (HI) on June 2 (U.S. time).
ErsoDetug is a fully human monoclonal antibody that binds to the insulin receptor in an allosteric manner, reducing receptor hyperactivity caused by insulin and related substances, thereby improving hypoglycemia in HI conditions.
The upLIFT study is a single-arm, open-label Phase 3 trial targeting patients with hypoglycemia due to insulinomas and non-beta cell tumors. So far, 8 out of the planned 16 participants have been enrolled.
Among the 8 enrolled patients, 6 met the primary endpoint of a 50% or greater reduction in the glucose infusion rate (GIR) compared to baseline. Some patients were able to discontinue intravenous glucose administration after treatment.
One patient withdrew consent before completing the core treatment period and stopped ErsoDetug and other non-curative treatments. The remaining patient is still receiving treatment. Those who completed the 8-week treatment period are participating in a long-term extension study, with cumulative treatment ongoing for up to 6 months.
ErsoDetug demonstrated overall good tolerability throughout both the core treatment and extension study phases. No drug-related adverse events or other safety concerns have been reported to date.
Resolute is a late-stage rare disease biotech company focused on treating various forms of hyperinsulinemia that cause hypoglycemia. HanDoc holds the rights for the domestic commercialization of ErsoDetug and continues its development collaboration with Resolute. Resolute plans to complete patient enrollment for the Phase 3 upLIFT study for tumor-induced hyperinsulinemia and announce topline results in the second half of this year.
* This article has been translated by AI.
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