Data monitoring committee OKs continuation of phase 3 trial for vidofludimus calcium

An independent data monitoring committee has ruled that a phase 3 clinical trial investigating vidofludimus calcium for relapsing MS may continue as originally planned, according to the therapeutic’s manufacturer.

Immunic Inc., said in a press release that review of a non-binding, interim futility analysis of its ENSURE program involving its oral immune modulator and nuclear receptor-related 1 activator found that the trials are “not futile” and can move forward.

The analysis by the independent data monitoring committee (DMC) was based on a pre-specified assessment when roughly half of pre-planned initial relapse events occurred in the double-blind treatment periods in both the ENSURE-1 and ENSURE-2 trials, Immunic said in the release. The goal of the analysis was to provide a framework to adjust the trials’ sample size while also acting as a barrier against a final readout occurring before enough of the relapse events occurred.

The DMC ultimately made its decisions based on two questions.

First, on whether the trials themselves were futile, the committee responded “futility criteria have not been met.” Second, on whether there should be an increase in sample size for both studies, the committee averred each should “continue as planned.”

“We are encouraged by the positive outcome of the interim analysis of our phase 3 ENSURE program, which validates the strength of our clinical approach and vidofludimus calcium’s potential in addressing relapsing MS,” Immunic CEO Daniel Vitt, PhD, told Healio in an email. “The independent data monitoring committee’s recommendation to continue both trials without modifications is an important step forward, bringing us closer to offering a much-needed oral treatment option for patients with MS.”

Immunic’s ENSURE program for vidofludimus calcium features concurrent, identical multicenter, randomized, double-blind studies looking at the safety, efficacy and tolerability of the investigational therapy in individuals with relapsing MS (RMS) compared with placebo.

Both studies are expected to enroll more than 1,000 adults with active RMS across more than 100 sites around the world.

According to the release, enrollees will be randomly assigned to receive either 30 mg daily doses of vidofludimus calcium or placebo, with the primary endpoint for both trials as time to first relapse up to 72 weeks.

Immunic also stated in the release that it expects ENSURE-1 to be completed within the second quarter of 2026, with ENSURE-2 expected to follow in the second half of 2026.