Immunic Announces Publication of Extended Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis in the Peer Reviewed Journal, Neurology® Neuroimmunology & Neuroinflammation
Rhea-AI Summary
Immunic, Inc. (IMUX) announces publication of data from its phase 2 EMPhASIS trial of vidofludimus calcium in patients with relapsing-remitting multiple sclerosis (RRMS) in Neurology® Neuroimmunology & Neuroinflammation. The study shows that vidofludimus calcium suppresses MRI lesions by 76% to 78% compared to placebo, reduces disability worsening events, and displays a dose-dependent effect in RRMS patients. Immunic continues with phase 3 ENSURE trials in relapsing MS and phase 2 CALLIPER trial in progressive MS.
Positive
Vidofludimus calcium demonstrated a significant suppression of MRI lesions, reducing gadolinium-enhancing lesions by 74% to 78% compared to placebo in the phase 2 EMPhASIS trial.
The drug showed encouraging results in reducing disability worsening events in RRMS patients during the treatment period.
The safety profile of vidofludimus calcium was similar to placebo, and the drug was well-tolerated by patients in the study.
Negative
Results showed that the 10 mg dose of vidofludimus calcium did not exhibit robust activity on multiple endpoints, indicating that 30 mg is the lowest effective dose.
The study revealed a dose-dependent effect on serum neurofilament light chain levels, with variations observed at different doses of vidofludimus calcium.
A small percentage of patients experienced confirmed disability worsening events despite treatment with vidofludimus calcium.
News Market Reaction – IMUX
On the day this news was published, IMUX gained 2.44%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
– 30 mg and 45 mg Daily Doses of Vidofludimus Calcium Suppressed Development of Gadolinium-Enhancing Lesions by
– Improvements in Serum Neurofilament Light Chain Consistent with Recently Announced Interim Phase 2 CALLIPER Data in Progressive Multiple Sclerosis –
– Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain Underway –
The paper, lead authored by coordinating investigator, Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic,
"The publication of our phase 2 EMPhASIS trial results for both study cohorts with an extended dose range in such a prestigious peer-reviewed journal represents further evidence of the strength of these findings for vidofludimus calcium in patients with RRMS," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "As reported, a dose-dependent effect of vidofludimus calcium on the suppression of new combined unique active (CUA) magnetic resonance imaging (MRI) as well as gadolinium-enhancing (Gd+) lesions was demonstrated along with an encouraging initial signal towards reducing 12-week and 24-week confirmed disability worsening events as compared to placebo during the double-blind treatment period. The findings impressively underline the drug's combined neuroprotective and anti-inflammatory effects. Meanwhile, we continue to enroll patients in our twin phase 3 ENSURE trials in relapsing multiple sclerosis, from which we expect to report an interim futility analysis in late 2024, with the top-line readout of the first of the ENSURE trials anticipated in the second quarter of 2026."
Vidofludimus calcium, an orally available first-in-class nuclear receptor related 1 (Nurr1) activator and next-generation dihydroorotate dehydrogenase (DHODH) inhibitor, was shown to have suppressed MRI disease activity compared to placebo in patients with RRMS in the first cohort of the multicenter, double-blind, randomized, placebo-controlled phase 2 EMPhASIS trial, achieving all primary and key secondary endpoints with high statistical significance. The results of study cohort 1, exploring the doses of 30 mg and 45 mg of vidofludimus calcium in RRMS patients versus placebo, were published in Annals of Clinical and Translational Neurology in 2022 (Fox RJ, et al. Ann Clin Transl Neurol. 2022;9(7):977-987).
Given that both doses of 30 mg and 45 mg of vidofludimus calcium showed comparable robust activity on multiple endpoints, the trial enrolled an additional cohort of patients to receive a lower dose of vidofludimus calcium in order to further investigate a dose-response relationship by extending the trial to a broader dose range. Study cohort 2 explored the dose of 10 mg of vidofludimus calcium versus placebo. Extended results from the pooled EMPhASIS data (cohorts 1 and 2, including comparison to the pooled placebo group from both study cohorts) were summarized in more detail in this latest peer-reviewed article.
The pooled data showed that, compared to placebo, vidofludimus calcium suppressed the development of new CUA MRI lesions with daily doses of 30 mg and 45 mg up to week 24 by
Increases in disability over a pre-defined disability change threshold (defined as trigger events and measured by Expanded Disability Status Scale, EDSS) during the double-blind treatment period were confirmed after 12 or 24 weeks, designating them confirmed disability worsening (CDW) events. The number of patients who had confirmed 12- or 24-weeks CDW events was
Finally, the pooled data set also reinforced that vidofludimus calcium was well-tolerated, in general, and that its safety profile was similar to the placebo group. Across cohorts 1 and 2, a total of 268 patients were randomized to 10 mg (n=47), 30 mg (n=71), or 45 mg (n=69) of vidofludimus calcium or placebo (n=81).
About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the
Contact Information
Immunic, Inc.
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FAQ
What is the significance of the publication of Immunic's phase 2 EMPhASIS trial data?
Where can the paper with the extended results from the phase 2 trial be accessed?
What is the status of Immunic's phase 3 ENSURE trials?
