– Improvement in Serum Neurofilament Light
Chain (NfL) Observed in Both Treatment Arms of Vidofludimus Calcium
Over Placebo –
– NfL Effect Consistent With Recently Released
Data from Separate, Phase 2 CALLIPER Trial of Vidofludimus Calcium
in Progressive Multiple Sclerosis –
NEW
YORK, Oct. 11, 2023 /PRNewswire/
-- Immunic, Inc. (Nasdaq: IMUX), a
biotechnology company developing a clinical pipeline of orally
administered, small molecule therapies for chronic inflammatory and
autoimmune diseases, announced that Robert
J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple
Sclerosis, Vice-Chair for Research, Neurological Institute,
Cleveland Clinic, Cleveland, Ohio,
today presented data from the company's phase 2 EMPhASIS trial of
nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium
(IMU-838), in relapsing-remitting multiple sclerosis (RRMS) at
MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting, taking place
October 11-13 in Milan, Italy.
"The neurologic biomarker NfL has been consistently found to
correlate with both clinical relapses as well as magnetic resonance
imaging (MRI) disease activity in MS patients," stated Dr. Fox. "In
the EMPhASIS trial, treatment with vidofludimus calcium was
associated with a decrease in serum NfL compared to placebo in the
overall study population, and even among subjects with no MS
activity during the study." Dr. Fox has served as Coordinating
Investigator in Immunic's multiple sclerosis (MS) programs and
receives consulting fees for serving as an advisor to Immunic.
Daniel Vitt, Ph.D., Chief
Executive Officer and President of Immunic, added, "The observation
in our EMPhASIS trial that vidofludimus calcium shows a meaningful
improvement in serum NfL even in a non-active MS patient population
is very encouraging, as it suggests that the drug may even be
active in the absence of inflammation, further supporting a
potential role in neuroprotection. We believe that these effects
may be related to vidofludimus calcium's potent Nurr1
activation."
Poster Details:
- Title: Reduction in Neurofilament Light Chain by
Vidofludimus Calcium: The EMPhASIS Study
- Abstract Number: 1290
- ePoster Number: P1390
- Poster Session: Imaging and non-imaging biomarkers -
Fluid Biomarkers
- The poster presentation is accessible on the "Events and
Presentations" section of Immunic's website at:
https://ir.imux.com/events-and-presentations.
EMPhASIS was an international, multicenter, double-blind,
placebo-controlled, randomized, parallel-group trial, designed to
assess the efficacy and safety of vidofludimus calcium in patients
with RRMS. The trial randomized 268 RRMS patients and included a
24-week blinded main treatment period testing 10, 30 and 45 mg of
vidofludimus calcium and placebo. The trial achieved both primary
and key secondary endpoints with high statistical significance, and
a safety and tolerability profile similar to placebo. The trial is
currently continuing in the open-label extension phase running up
to 9.5 years.
On October 9, 2023, Immunic
announced positive interim data from its phase 2 CALLIPER trial of
vidofludimus calcium in patients with progressive multiple
sclerosis (PMS). The 24-week data from the first half of patients
showed improvements in NfL, consistent throughout the overall PMS
population as well as all sub-analyses.
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 1,400
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 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,
where 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 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,
2022, filed with the SEC on February
23, 2023, 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
Head of 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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SOURCE Immunic, Inc.