– 30 mg and 45 mg Daily Doses of Vidofludimus
Calcium Suppressed Development of Gadolinium-Enhancing Lesions by
78% and 74% Compared to Pooled Placebo at 24 Weeks –
– 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 –
NEW
YORK, April 30, 2024 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a biotechnology company developing a
clinical pipeline of orally administered, small molecule therapies
for chronic inflammatory and autoimmune diseases, today announced
that data from its phase 2 EMPhASIS trial of lead asset,
vidofludimus calcium (IMU-838), in patients with
relapsing-remitting multiple sclerosis (RRMS) has been published
online on April 25, 2024 in
Neurology® Neuroimmunology & Neuroinflammation, an
official journal of the American Academy of Neurology.
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, Cleveland, Ohio, is entitled, "Safety and
Dose-Response of Vidofludimus Calcium in Relapsing Multiple
Sclerosis: Extended Results of a Placebo-Controlled Phase 2
Trial." Dr. Fox receives consulting fees for serving as an
advisor to Immunic. The paper can be accessed through the
following link:
https://www.neurology.org/doi/full/10.1212/NXI.0000000000200208.
"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 76% and 71%,
respectively. In addition, compared to placebo, vidofludimus
calcium suppressed the development of Gd+ lesions with daily doses
of 30 mg and 45 mg up to week 24 by 78% and 74%, respectively. Such
robust anti-inflammatory effects were not seen with 10 mg,
establishing 30 mg as the lowest effective dose. Serum
neurofilament light chain (NfL), which is thought to correlate with
neuronal destruction, decreased in a dose-dependent manner up to
the highest tested dose of vidofludimus calcium by 9% (10 mg),
18% (30 mg) and 26% (45mg) compared to
placebo, respectively, suggesting that the effect on NfL has a
different dose-response pattern which contrasts with that observed
with new CUA or Gd+ by MRI lesions.
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 3.7% for patients
receiving placebo and only 1.6% for patients receiving any dose of
vidofludimus calcium.
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
Ukraine – Russia conflict and the conflict in the
Middle East on planned and ongoing
clinical trials, risks and uncertainties associated with the
ability to project future cash utilization and reserves needed for
contingent future liabilities and business operations, the
availability of sufficient financial and other resources to meet
business objectives and operational requirements, the fact that the
results of earlier preclinical studies and clinical trials may not
be predictive of future clinical trial results, the protection and
market exclusivity provided by Immunic's intellectual property,
risks related to the drug development and the regulatory approval
process and the impact of competitive products and technological
changes. A further list and descriptions of these risks,
uncertainties and other factors can be found in the section
captioned "Risk Factors," in the company's Annual Report on Form
10-K for the fiscal year ended December 31,
2023, filed with the SEC on February
22, 2024, and in the company's subsequent filings with the
Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov or ir.imux.com/sec-filings. Any
forward-looking statement made in this release speaks only as of
the date of this release. Immunic disclaims any intent or
obligation to update these forward-looking statements to reflect
events or circumstances that exist after the date on which they
were made. Immunic expressly disclaims all liability in respect to
actions taken or not taken based on any or all the contents of this
press release.
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com
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