Immunic, Inc. (IMUX) is a clinical-stage biotechnology company, headquartered in New York City. However, most of the company’s research and development activities are conducted at its subsidiary in Munich, Germany. Immunic is developing small-molecule oral therapies for treating chronic inflammatory and autoimmune diseases.
In our last article, we took a deep dive into Immunic’s lead program IMU-838, with an emphasis on its ongoing Twin Phase 3 ENSURE Trials in Relapsing MS (RMS). The program focuses on developing a treatment for multiple sclerosis (MS) and its subtypes, including RMS and Progressive MS (PMS).
Today, we will explore the developments of the Phase 2 Calliper Trial in treating PMS. Importantly, we will learn about the expectations of the readout of the Phase 2 CALLIPER trial of vidofludimus calcium in progressive MS, which is expected in April 2025.
First, Let’s Learn About the CALLIPER Trial
The CALLIPER trial is aimed at finding the efficacy, safety, and tolerability of vidofludimus calcium in treating progressive MS. It is an international, multicenter, randomized, double-blind, placebo-controlled Phase 2 trial. Immunic has enrolled 467 patients at more than 70 sites in North America, Western, Central, and Eastern Europe. These patients exhibit primary PMS or active or non-active secondary PMS.
The Phase 2 CALLIPER trial is designed to run simultaneously with and complement the Twin Phase 3 ENSURE trials in RMS. Moreover, the CALLIPER trial is intended to validate vidofludimus calcium’s neuroprotective potential, mainly its ability to slow brain atrophy and delay disability worsening.
In this trial, patients were administered either 45 mg daily doses of vidofludimus calcium or placebo in a double-blind fashion (neither the participants nor the researchers know which group got the placebo and which one received the experimental treatment).
The Trial’s Key Focus Points
The primary endpoint of the phase 2 CALLIPER trial is to study the annualized rate of percent brain volume change up to 120 weeks. Further, the key secondary endpoints are to study 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).
Immunic Boasted Positive Interim Data from CALLIPER Trial
On October 9, 2023, Immunic reported positive interim data from its Phase 2 CALLIPER trial of nuclear receptor-related 1 (Nurr1) activator vidofludimus calcium (IMU-838) in treating patients with PMS. The study was based on the initial 24-week data from the first half of patients (203) undergoing the trial. The patient cohort was as follows: PMS (29%), non-active secondary PMS (61%), and active secondary PMS (10%).
The data revealed biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential. Importantly, the data was consistent across the overall PMS population and all subtypes. The data showed improvements in serum neurofilament light chain (NfL) and glial fibrillar acidic protein (GFAP).
At 24 weeks, the drug showed a 6.7% reduction from baseline in serum NfL as against an increase of 15.8% over baseline in placebo. At the same time, GFAP increased by 3.7% for vidofludimus calcium but by 4.4% for placebo.
Expectations from the Readout in April 2025
Immunic is expecting the brain volume data of the full 467 CALLIPER patient population in April 2025. The company hopes that the top-line data will continue to show the treatment’s neuroprotective effect.
Immunic noted that interim data showed strong improvements in serum NfL, which is higher than those observed in other therapeutic approaches for PMS and is a reason to believe that the company will be able to position the drug as a first oral treatment option for non-active SPMS (secondary progressive multiple sclerosis).
Importantly, the interim data showed clear separation from placebo in serum NfL levels in patients with PMS, including all subtypes. The differences in NfL levels were of particular importance in the non-active SPMS population, as this category of MS represents the most unmet medical need. Immunic looks forward to positive top-line data in order to commercialize the drug.
Should I Buy Immunic Stock?
On TipRanks, IMUX stock has a Moderate Buy consensus rating based on one Buy versus one Hold rating. The average Immunic price target of $16.50 implies 1,104.4% upside potential from current levels. IMUX shares have declined 6% so far this year.
This article was written in partnership with Immunic. TipRanks may be compensated for its publication.
