Fiscal 3Q26 - Phase 3 Tumor HI Data and Additional cHI Update Both Expected in Calendar 2H26

研报英文原文证据摘录

Fiscal 3Q26 - Phase 3 Tumor HI Data and Additional cHI Update Both Expected in Calendar 2H26

y of ersodetug in tumor HI is ongoing, recent study design update supports enhanced recruitment.

The study has been initiated and is currently enrolling patients in the US and Europe. Upon agreement with the FDA, mgmt.

has revised the study design to remove the double-blind placebo-controlled portion, simplifying the trial to now consist of aRESEARCH

single open-label arm. This arm is expected to enroll ~16 patients requiring continuous IV glucose to receive 9 mg/kg QW over

an 8wk pivotal treatment period. Patients will be evaluated on a primary endpoint of number of participants achieving ≥50%

reduction from baseline in IV glucose requirements. Additional efficacy endpoints in the study include discontinuation of glucose

infusion rate, time to discharge from hospital, hypoglycemia events measured by SMBG, hypoglycemia time in outpatient setting

measured by CGM, and patient-reported QoL.

sunRIZE data, in detail. 63 patients were enrolled in the clinical trial, with 55 randomized across the double-blind treatment arms.

The study did not meet the primary endpoint of change in average weekly hypoglycemia events by self-monitored blood glucose.

10mg/kg ersodetug patients showed a 45% reduction in hypoglycemia events, which was not statistically significant compared to

40% reduction in pbo. The key secondary endpoint (change in average daily % time in hypoglycemia by CGM) was not met. 10mg/

kg ersodetug patients demonstrated a 25% reduction in time in hypoglycemia vs. 5% increase in pbo, which was not a statistically

significant difference. Ersodetug target drug concentrations were achieved in the study dose regimens (5mg/kg and 10mg/kg