– Vidofludimus Calcium's Activation of Nurr1
Reduces Neuronal Loss and Injury Directly and Indirectly By
Decreasing Microglial Activations in Preclinical Models
–
– Top-Line Data from Phase 2 CALLIPER Trial of
Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in
April –
NEW
YORK, Feb. 26, 2025 /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 the presentation of data
on its lead asset, nuclear receptor-related 1 (Nurr1) activator,
vidofludimus calcium (IMU-838), in two poster presentations at the
Americas Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS) Forum 2025, taking place from February 27 to March 1, in West Palm Beach, Florida.
"Having two poster presentations on vidofludimus calcium at
the prestigious ACTRIMS Forum highlights the unique importance of
our drug candidate and its promise as a potential new treatment
option for multiple sclerosis (MS)," stated Daniel Vitt, Ph.D., Chief Executive Officer of
Immunic. "For the first time, we analyzed the baseline
characteristics of patients in subpopulations from our phase 2
CALLIPER trial in progressive multiple sclerosis (PMS), and
compared to those from four major PMS trials. The goal of this
analysis was to identify how the differences may impact
comparability of trial outcomes, including our top-line data
readout of the phase 2 CALLIPER trial, expected in April. The
CALLIPER data is expected to provide valuable insights into the
effects of vidofludimus calcium in a non-active PMS population. We
believe any impact of vidofludimus calcium on 24-week confirmed
disability worsening in this group would likely primarily reflect
its influence on compartmentalized pathology within the central
nervous system, expressed clinically as progression independent of
relapse activity (PIRA)."
Presentation Details:
- Poster Title: Baseline Characteristics Across Major
Clinical Trials in Progressive Multiple Sclerosis: Insights from
ORATORIO, EXPAND, MS-STAT2, HERCULES, and CALLIPER
- Presenting Author: Robert J.
Fox, M.D., Staff Neurologist, Mellon Center for Multiple
Sclerosis, Vice-Chair for Research, Neurological Institute,
Cleveland Clinic, Cleveland,
Ohio
- Abstract Number: 452
- Poster Number: P102
- Poster Session: 1
- Session Date: Thursday, February
27, 2025
- Session Time: 6:00 pm –
7:30 pm ET (even-numbered posters
present from 6:00-6:45 pm)
Hella Kohlhof, PhD., Chief
Scientific Officer of Immunic, continued, "Our second poster
highlights, via a series of both in vitro and in vivo
experiments, evidence of the neuroprotective potential of
vidofludimus calcium through its activation of the transcription
factor Nurr1. Overall, the data from these preclinical studies
underlines that vidofludimus calcium reduces neuronal loss and
injury directly and indirectly by decreasing microglial activation
and that its potential neuroprotective effects are most likely
mediated by Nurr1."
Presentation Details:
- Poster Title: Vidofludimus Calcium Shows a Potential
Neuroprotective Function in Multiple Sclerosis through its Activity
on Nurr1 in Preclinical Models
- Presenting Author: Evelyn
Peelen, Ph.D., Head of Research, Immunic
- Abstract Number: 427
- Poster Number: P317
- Poster Session: 2
- Session Date: Friday, February
28, 2025
- Session Time: 6:00 pm –
7:30 pm ET (odd-numbered posters
present from 6:45-7:30 pm)
Both poster presentations will be accessible on the "Events and
Presentations" section of Immunic's website at:
https://ir.imux.com/events-and-presentations.
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 effects. Additionally,
vidofludimus calcium is a highly selective 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 as well as
inflammatory bowel disease, Graft-versus-Host-Disease and weight
management. 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 and cash
runway, 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, including the
ability to satisfy the minimum average price and trading volume
conditions required to receive funding in tranche 2 and 3 of the
January 2024 private placement, the
fact that the results of earlier preclinical studies and clinical
trials may not be predictive of future clinical trial results, any
changes to the size of the target markets for the Company's
products or product candidates, 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 of 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
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com
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SOURCE Immunic, Inc.
