Immunic Inc (NASDAQ:IMUX) said it has completed the enrollment of its phase 2 CALLIPER trial of lead asset vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS).
A total of 467 patients with primary MS or active or non-active secondary MS have been randomized to either 45mg of vidofludimus calcium or placebo. The trial focuses on progressive forms of MS and is designed to corroborate vidofludimus calcium's neuroprotective potential in this patient population.
The company said one anticipated milestone for the trial includes an interim analysis comprising unblinded biomarker data, including serum neurofilament light chain which is expected to be available in the fall of 2023 for approximately half of the enrolled patients who have completed a follow-up period of at least 24 weeks of study treatment.
Another milestone expected is a top-line data readout of the full 467 patients which is expected in April of 2025.
"Our phase 2 CALLIPER trial is designed to corroborate the neuroprotective potential of vidofludimus calcium in a progressive patient population. Enrollment of the final PMS patient, according to plan, is another important milestone in the clinical development of our lead asset in MS," stated Daniel Vitt, Ph.D., chief executive officer and president of Tmmunic.
"We believe that the data from the CALLIPER trial, along with that from our ENSURE program, in conjunction with vidofludimus calcium's postulated neuroprotective effects as a first-in-class nuclear receptor related 1 (Nurr1) activator as well as its strong safety and tolerability profile shown, to date, may further strengthen the uniqueness of this treatment approach compared to other oral MS medications and result in a highly attractive commercial positioning."
CALLIPER is an international, multicenter, randomized, double-blind, placebo-controlled phase 2 trial which enrolled patients at over 70 sites throughout North America as well as Western, Central and Eastern Europe. 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. Vidofludimus calcium has been tested in more than 1,400 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. It has yet to be licensed in any country.