Immunic Therapeutics Enrolls First Patient in Phase 2 Trial of IMU-838 for RRMS

Immunic Therapeutics has enrolled the first patient in its Phase 2 clinical trial testing IMU-838, a potential oral therapy for relapsing-remitting multiple sclerosis (RRMS).

IMU-838 (vidofludimus calcium) is a next-generation selective modulator of the immune system. It works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which plays a role in the metabolism of activated immune T- and B-cells. The inhibition of DHODH leads to a reduction of pro-inflammatory factors.

The approved MS disease-modifying therapy Aubagio (teriflunomide, marketed by Sanofi Genzyme) also works by inhibiting DHODH.

“The mode of action of IMU-838, DHODH inhibition, is already commercially proven in RRMS, and the safety and tolerability profiles of IMU-838 are well understood,” Andreas Muehler, MD, chief medical officer of Immunic, said in a press release.

“We look forward to carrying out this trial in support of further clinical data showing IMU-838 as a potentially best-in-class, once-daily oral therapy to treat RRMS,” Muehler said.

The Phase 2 study (NCT03846219) evaluating IMU-838 in RRMS patients will be conducted at more than 40 centers across Europe, including Romania, Bulgaria, Ukraine, and Poland. Approximately 200 RRMS patients with evidence of active disease are expected to be enrolled.

The primary goal of the trial is to evaluate the effects of a daily dose of 30 mg/day or 45 mg/day of IMU-838 on RRMS disease progression based on magnetic resonance imaging (MRI) assessments. A placebo group will be included in the trial.

Patients will be treated for 24 weeks, at which time the effects of the treatment will be assessed. The treatment period then can be optionally extended (open-label extended treatment period) to assess the long-term safety and tolerability of IMU-838.

“Enrollment of the first patient in this trial as planned and on schedule represents another key milestone for Immunic, and demonstrates the ability of our company to effectively execute our drug development strategy,” said Daniel Vitt, PhD, chief executive officer of Immunic.

“We had already advanced IMU-838 into a phase 2 trial for ulcerative colitis, so we are excited about its clinical testing in this additional patient population. This development further advances our goal of expanding the indications for which IMU-838 shows great promise for patients with chronic inflammatory and autoimmune diseases,” Vitt said.