Rezolute Updates on Phase 3 Study Progress of ersodetug
Rezolute provided an interim update on its ongoing open-label Phase 3 study of ersodetug in tumor HI. With eight participants enrolled in upLIFT to date, comprising both insulinoma and non-islet cell tumor hypoglycemia, the company is midway through enrollment of the planned study sample size of 16 participants. Of the 8 participants enrolled, 6 have already met the responder criterion for the study's primary endpoint, which is the number of participants achieving at least a 50% reduction from baseline in intravenous glucose requirements within the 8-week pivotal treatment phase. Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug. One of the 8 enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status. The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint. The 8th participant was recently enrolled and is still dosing in the pivotal phase of the study. All participants that have completed the 8-week pivotal treatment period have elected to continue into the open-label extension, with a cumulative treatment duration of up to 6 months. Ersodetug has been well-tolerated in the pivotal and extension phases of the study, with no drug-related adverse events or other safety findings reported to date.
