– Data Show Encouraging Signals for
Vidofludimus Calcium for Preventing or Delaying Confirmed
Disability Worsening –
– Virtual Multiple Sclerosis R&D Day to be
Held Today, November 17, 2022 at
11:00 am ET –
NEW
YORK, Nov. 17, 2022 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company
developing a pipeline of selective oral immunology therapies
focused on treating chronic inflammatory and autoimmune diseases,
today reported newly available data from its phase 2 EMPhASIS trial
of lead asset, vidofludimus calcium (IMU-838), in
relapsing-remitting multiple sclerosis (RRMS). Long-term open-label
treatment with vidofludimus calcium was associated with a low rate
of confirmed disability worsening over time, and compares favorably
to historical trial data for currently available multiple sclerosis
(MS) medications.
EMPhASIS is 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 included a 24-week blinded main treatment
period testing 10, 30 and 45 mg of vidofludimus calcium and
placebo. In the third quarter of 2020, Immunic reported that the
trial achieved both primary and key secondary endpoints with high
statistical significance, with a safety and tolerability profile
similar to placebo.
The trial also includes an optional long-term open-label
extension (OLE) phase running up to 9.5 years. An interim analysis
was performed with data extraction in October 2022, when 209 patients remained on
treatment in the OLE phase, some of whom have already received more
than 180 continuous weeks (approximately four years) of active
treatment with vidofludimus calcium.
During the 24-week double-blind main treatment period, 12-week
and 24-week Confirmed Disability Worsening (12w/24wCDW) events
occurred in 1.6% of subjects in the combined vidofludimus calcium
treatment arms as compared to 3.7% in the placebo group. In the OLE
phase, the proportion of patients free from 12wCDW was 97.6% after
48 weeks and 94.5% after 96 weeks of vidofludimus calcium treatment
as compared to the start of the OLE phase. Similar results were
observed for 24wCDW and sustained CDW. The OLE phase also showed
low relapse activity.
"The newly obtained data from our phase 2 EMPhASIS trial of
vidofludimus calcium in RRMS patients demonstrate an encouraging
signal in preventing 12-week and 24-week confirmed disability
worsening events as compared to placebo during the double-blind
treatment phase. In addition, only a few patients on continuous
open-label treatment with vidofludimus calcium developed confirmed
disability worsening events over a 2-year time frame, and those
rates observed with vidofludimus calcium are on the lower end of
those observed in historical trials with currently approved MS
medications," stated Daniel Vitt,
Ph.D., Chief Executive Officer and President of Immunic. "We look
forward to receiving further, confirmatory data from our phase 3
ENSURE program in relapsing MS as well as our phase 2 CALLIPER
trial in progressive MS. Our next MS-related data inflection point
is an interim analysis for CALLIPER at the end of 2023 which will
provide selected biomarker and functional data to guide study
progress. If approved, we believe that vidofludimus calcium has the
potential to be a unique treatment option targeted to the biology
of MS with combined anti-inflammatory, antiviral, and
neuroprotective effects."
Multiple Sclerosis R&D Webcast
Immunic will host a Multiple Sclerosis R&D Webcast today,
November 17, 2022 at 11:00 am ET. During the event, Immunic will
provide an update on the scientific, preclinical and clinical
progress of vidofludimus calcium in MS. In addition to the
above-mentioned new data from the EMPhASIS trial, the presentation
will include an update the ongoing phase 3 ENSURE program in
relapsing MS and the ongoing phase 2 CALLIPER trial in progressive
MS, as well as the drug's potential strategic and commercial
positioning in the MS landscape.
Moreover, three invited key opinion leaders will discuss recent
scientific findings and their effect on the MS treatment landscape.
The featured experts will be:
- Fred D. Lublin, M.D., Saunders Family Professor of Neurology,
Director, The Corinne Goldsmith Dickinson Center for Multiple
Sclerosis, Icahn School of Medicine, Mount Sinai Hospital,
New York, NY, USA
-
- Dr. Lublin will discuss new data published in 2022
illustrating that relapse-independent worsening is responsible for
approximately 50% of disability worsening in the relapsing phase of
MS, and 100% in the progressive phase of MS (Lublin
FD, et al. How patients with multiple sclerosis
acquire disability. Brain. 2022 Sep
14;145(9):3147-3161).
- Lawrence Steinman, M.D.,
Professor of Neurology and Neurological Sciences, Pediatrics, and
Genetics, Stanford University School of
Medicine, Department of Neurology & Neurological Sciences,
Stanford, CA, USA
-
- Dr. Steinman will present new data published in 2022 confirming
the presence of cross-reactive antibodies between the Epstein-Barr
virus (EBV) antigen EBNA1 and the central nervous system (CNS)
protein GlialCAM found in the cerebrospinal fluid of MS patients
(Robinson WH, Steinman L. Epstein-Barr virus and multiple
sclerosis. Science. 2022 Jan 21;375(6578):264-265).
- Heinz Wiendl, M.D., Ph.D.,
Director Department of Neurology with Institute of
Translational Neurology, University of Münster, Münster,
Germany
-
- Dr. Wiendl will elaborate on new data published in 2022 showing
that T cells in MS patients continuously recognize known EBV
antigens not seen in a control group, consistent with an ongoing
anti-EBV immune reaction in MS patients (Schneider-Hohendorf T, et
al. Broader Epstein-Barr virus-specific T cell receptor repertoire
in patients with multiple sclerosis. J Exp Med. 2022 Nov 7;219(11):e20220650).
Speakers from Immunic will be:
- Daniel Vitt, Ph.D., Chief
Executive Officer and President
- Andreas Muehler, M.D., M.B.A.,
Chief Medical Officer
- Hella Kohlhof, Ph.D., Chief
Scientific Officer
"We look forward to discussing the preclinical and clinical
development progress of vidofludimus calcium at our MS R&D Day
and would like to extend our thanks to Dr. Fred Lublin, Dr.
Larry Steinman and Dr. Heinz Wiendl for joining the event," said
Andreas Muehler, M.D., Chief Medical
Officer of Immunic. "We are very excited that these three experts,
the main authors of three major publications changing our
pathophysiological understanding of MS, are part of this R&D
Day. Dr. Lublin's analysis showed that there is a major component
of disability worsening, even in early MS disease, that is
independent of relapse and supports the notion that a smoldering,
slowly progressing disease is an essential part of this disease.
The publications by Dr. Steinman and Dr. Wiendl provide strong new
evidence that EBV and related immune reactions may play a role
during the course of the disease and may be hypothesized to
contribute to a smoldering chronic infection. We believe that
vidofludimus calcium, with its signal in preventing or delaying
confirmed disability worsening seen in our phase 2 EMPhASIS trial
and its well documented antiviral activity, including on EBV, is
well positioned to address the newly highlighted mechanisms of
disease progression."
Webcast Information
The MS R&D webcast will be held virtually via Zoom. To
participate, please register in advance at:
https://imux.zoom.us/webinar/register/WN_vVIraQmQTpG2dmAb8c9Qng.
Registrants will receive a confirmation email containing a link
for online participation or a telephone number for dial in
access.
An archived replay of the webcast will be available
approximately one hour after completion on the "Events and
Presentations" section of Immunic's website at:
ir.imux.com/events-and-presentations.
About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is an investigational drug in development
as an orally available, next-generation selective immune modulator
that is designed to inhibit the intracellular metabolism of
activated immune cells by blocking the enzyme dihydroorotate
dehydrogenase (DHODH). Vidofludimus calcium has been observed in
preclinical studies to act on activated T and B cells while leaving
other immune cells largely unaffected and allows the immune system
to stay functioning, e.g., in fighting infections. In previous
trials, vidofludimus calcium did not show an increased rate of
infections compared to placebo. In addition, DHODH inhibitors, such
as vidofludimus calcium, are known to possess a host-based
antiviral effect, which is independent with respect to specific
virus proteins and their structure. Therefore, DHODH inhibition may
be broadly applicable against multiple viruses. To date,
vidofludimus calcium has been tested in more than 1,100 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 clinical-stage
biopharmaceutical company with a pipeline of selective oral
immunology therapies focused on treating chronic inflammatory and
autoimmune diseases. The company is developing three small molecule
products: its lead development program, vidofludimus calcium
(IMU-838), a selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme DHODH and exhibits a host-based antiviral effect, is
currently being developed as a treatment option for multiple
sclerosis. IMU-935, a selective inverse agonist of the
transcription factor RORγ/RORγt, is targeted for development in
psoriasis, and castration-resistant prostate cancer. IMU-856, which
targets the restoration of the intestinal barrier function, is
targeted for development in diseases involving bowel barrier
dysfunction. 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 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 three
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 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, 2021, filed with the SEC
on February 24, 2022, 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.