Immunic

Immunic's IDMC advises continuation of phase 3 ENSURE program for vidofludimus calcium in RMS; CHMP recommends approval for Ionis and AstraZeneca's eplontersen for ATTRv-PN; first patient dosed in ARTHEx's phase 1/2 trial for ATX-01 in DM1.

Immunic's IDMC reviewed interim data from the phase 3 ENSURE program assessing vidofludimus calcium in relapsing multiple sclerosis (RMS), advising trials continue as planned. ENSURE includes two identical trials (ENSURE-1, ENSURE-2) with time to first relapse up to 72 weeks as the primary endpoint. The IDMC found no futility, suggesting the planned sample size is appropriate for the primary endpoint. Both trials are expected to complete in 2026.

IDMC confirms ENSURE program's phase 3 trials of vidofludimus calcium for RMS are not futile, recommending continuation without changes. Trials remain on track for completion in 2026.

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Immunic, Inc. announced a positive interim futility analysis for its phase 3 ENSURE program, investigating vidofludimus calcium for relapsing multiple sclerosis. The Independent Data Monitoring Committee recommended continuing the trials unchanged, with completion expected in 2026. Vidofludimus calcium shows potential as a first-in-class oral treatment for multiple sclerosis.

Immunic, Inc. announced a positive interim futility analysis for its phase 3 ENSURE program, investigating vidofludimus calcium for relapsing multiple sclerosis. The Independent Data Monitoring Committee recommended continuing the trials unchanged, with completion expected in 2026. The program remains on track, with a webcast scheduled for October 22, 2024.