CALLIPER Trial for Progressive MS Enrolls First Patient

Immunic Therapeutics has enrolled the first patient in a Phase 2 clinical trial testing its oral therapy candidate IMU-838 for the treatment of progressive multiple sclerosis (MS).

The trial, CALLIPER (NCT05054140), is expected to run in parallel to the company’s two identically-designed Phase 3 trials, dubbed ENSURE-1 and ENSURE-2, to assess the therapeutic potential of IMU-838 in patients with relapsing-remitting MS (RRMS).

According to Immunic, the ENSURE trials are expected to start by year’s end.

“Enrollment of the first [progressive] MS patient in our phase 2 CALLIPER trial, on schedule, is another important clinical milestone for our lead asset, IMU-838, and we continue to anticipate initiating our phase 3 ENSURE program in RRMS patients in the fourth quarter of this year,” Daniel Vitt, PhD, CEO and president of Immunic, said in a press release.

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The results of both CALLIPER and the ENSURE trials are expected to confirm the neuroprotective benefits of IMU-838.

“We believe that if the CALLIPER trial is successful in showing a beneficial neuroprotective effect of IMU-838, this data, along with that of the ENSURE program and IMU-838’s already proven, strong safety and tolerability profile, may allow us to draw a clear clinical differentiation for IMU-838 versus other oral MS medications, resulting in an attractive commercial positioning as a transformative therapeutic treatment,” Vitt said.

The Phase 2 CALLIPER will be conducted at more than 70 centers in North America and Europe. Approximately 450 adults (ages 18–65) with progressive types of MS, which includes primary progressive MS (PPMS) and secondary progressive MS (SPMS), are expected to participate. More information about enrollment is available here.

Patients will be assigned randomly to receive oral IMU-838 (45 mg) or a placebo once daily.

The trial’s main goal is to assess the effect of treatment on brain volume up to 120 weeks (over two years). Disability-related measures also will be assessed.

An interim analysis will be done after approximately half of the patients have completed 24 weeks of treatment, during which researchers will measure the levels of a marker of nerve cell damage called neurofilament light chain (NfL).

“The interim analysis to assess NfL is key, as it has been shown to consistently correlate with disease activity in neurological disorders and has become one of the most important serum biomarkers for axonal [nerve fibers] damage over the past few years,” said Andreas Muehler, MD, chief medical officer of Immunic. “If the CALLIPER trial is successful in showing beneficial data, we believe this could be an essential differentiator for IMU-838 in the MS market.”

IMU-838 is a next-generation selective modulator of the immune system. It was designed to block the metabolism of active immune T- and B-cells, and modulate their function. Both cell types are known to take part in the mistaken autoimmune attack on myelin — the coating that protects the nerve fibers — causing a variety of MS symptoms.