CALLIPER is an international, multicenter, randomized, double-blind, placebo-controlled phase 2 trial expected to enroll approximately 450 patients at more than 70 sites in North America, Western, Central and Eastern Europe, with patients randomized to either 45 mg daily doses of IMU-838 or placebo. The trial’s primary endpoint is the annualized rate of percent brain volume change up to 120 weeks. Key secondary endpoints include the annualized rate of change in whole brain atrophy and time to 24-week confirmed disability progression based on the expanded disability status scale (EDSS). An interim analysis comprising an unblinded analysis of serum neurofilament light chain (NfL) is planned to occur once approximately half of the enrolled patients have completed 24 weeks of treatment.

“Enrollment of the first PMS 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,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “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.”

“The CALLIPER trial is designed to further explore IMU-838’s neuroprotective potential, as exemplified by a slowing of brain atrophy and delay in disability worsening, which is often caused by axonal and neural damage,” added Andreas Muehler, M.D., Chief Medical Officer of Immunic. “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 damage over the past few years. 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.”

About Progressive Multiple Sclerosis
Multiple sclerosis (MS) is an autoimmune disease that affects the brain, spinal cord and optic nerve. In MS, myelin, the coating that protects the nerves, is attacked and damaged by the immune system. Thus, MS is considered an immune-mediated demyelinating disease of the central nervous system. Progressive multiple sclerosis (PMS) includes both primary progressive MS (PPMS) and secondary progressive MS (SPMS). PPMS is characterized by steadily worsening neurologic function from the onset of symptoms without initial relapse or remissions. SPMS is identified following an initial relapsing remitting course, after which the disease becomes more steadily progressive, with or without other disease activity present.

About IMU-838
IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning, e.g. in fighting infections. In previous trials, IMU-838 did not show an increased rate of infections compared to placebo. In addition, DHODH inhibitors, such as IMU-838, are known to possess a host-based antiviral effect, which is independent with respect to specific virus proteins and their structure. Therefore, DHODH inhibition may be broadly applicable against multiple viruses. IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in a phase 2 trial in patients with ulcerative colitis. In the third quarter of 2020, the company reported positive results from its phase 2 EMPhASIS trial of IMU-838 in relapsing-remitting multiple sclerosis, achieving both primary and key secondary endpoints with high statistical significance. In the first quarter of 2021, Immunic announced that IMU-838 showed evidence of clinical activity in its phase 2 CALVID-1 trial in hospitalized patients with moderate COVID-19. Also, in the first quarter of 2021, the company reported positive top-line data from an investigator-sponsored phase 2 proof-of-concept clinical trial of IMU-838 in primary sclerosing cholangitis which was conducted in collaboration with Mayo Clinic. To date, IMU-838 has been tested in more than 800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. IMU-838 is not yet licensed or approved in any country.

About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, IMU-838, a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect, is currently being developed as a treatment option for multiple sclerosis, ulcerative colitis, Crohn’s disease, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor RORγt, is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barré syndrome. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction. For further information, please visit: www.imux.com.