Immunic Announces Positive Outcome From Interim Futility Analysis Of Phase 3 ENSURE Program

(RTTNews) - Immunic, Inc. (IMUX) Tuesday announced positive outcome from the interim futility analysis of its Phase 3 ENSURE program evaluating the company's lead asset, IMU-838 for the treatment of relapsing multiple sclerosis.

Futility analysis is a statistical process that assesses if a clinical trial should be stopped early because it is unlikely to achieve its objectives.

Based on the data from the interim futility analysis an Independent Data Monitoring Committee (IDMC) has recommended that the ENSURE program comprising ENSURE-1 and ENSURE-2 studies are not futile and should continue as planned. The analysis was performed after about half of the planned first relapse events occurred in the treatment periods of each of the ENSURE-1 and ENSURE-2 trials.

The company said its ENSURE studies remain on track to be completed in 2026.