Immunic, Inc. (Nasdaq: IMUX) has announced significant progress in the clinical development of its lead asset, vidofludimus calcium (IMU-838), for the treatment of multiple sclerosis (MS). The biotechnology company is advancing both its phase 2 CALLIPER trial in progressive MS (PMS) and its twin phase 3 ENSURE trials in relapsing MS (RMS).
CALLIPER Trial: Anticipated Top-Line Data
Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS is expected in April. Interim results from the CALLIPER trial have indicated a reduction in neurofilament light chain (NfL) levels compared to placebo, suggesting potential neuroprotective effects of the drug. NfL is a biomarker of nerve cell damage, and its reduction hints at the drug's ability to slow down neurodegeneration in PMS patients.
ENSURE Trials: Positive Interim Results
The twin phase 3 ENSURE trials, ENSURE-1 (NCT05134441) and ENSURE-2 (NCT05201638), are investigating vidofludimus calcium for the treatment of RMS. An unblinded Independent Data Monitoring Committee (IDMC) conducted an interim analysis and concluded that the trials are not futile, recommending they continue as planned without any sample size increase. Completion of ENSURE-1 is anticipated in the second quarter of 2026, with ENSURE-2 expected to follow in the second half of 2026.
Vidofludimus Calcium: A Novel Approach
Vidofludimus calcium is an orally available small molecule that acts as a nuclear receptor related 1 (Nurr1) activator, providing neuroprotective effects. It also selectively inhibits the enzyme dihydroorotate dehydrogenase (DHODH), which has anti-inflammatory and antiviral effects. This dual mechanism of action could potentially address both the neuroinflammatory and neurodegenerative aspects of MS.
Jason Tardio, President and Chief Operating Officer of Immunic, stated, "There continues to be a large unmet medical need for new therapeutic advancements in the treatment of MS that address both the neuroinflammatory and neurodegenerative aspects of the disease to better slow disability worsening."
IMU-856: Targeting Gastrointestinal Disorders
Immunic also highlighted the publication of data from the phase 1/1b clinical trial of IMU-856 in The Lancet Gastroenterology & Hepatology. IMU-856 is an orally available small molecule modulator targeting Sirtuin 6 (SIRT6), a protein involved in intestinal barrier function and bowel epithelium regeneration. The data showed positive effects in patients with celiac disease, including protection of gut architecture, improvement of symptoms, biomarker response, and enhanced nutrient absorption.
Corporate Developments
In January 2024, Immunic announced a three-tranche private placement totaling up to $240 million, extending the company's cash runway into the third quarter of 2025. The company also strengthened its management team and Board of Directors with key hires.
