Full Press Release Details
Immunic, Inc. to Present Preclinical Data
for Vidofludimus Calcium at the 17th Congress of European Crohn's and Colitis Organization and Announces Blinded Baseline Characteristics
of its Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Ulcerative Colitis
Top-Line Data of the CALDOSE-1 Trial Expected to be Available in June of 2022 -
February 18, 2022 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline
of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced that Evelyn Peelen,
Ph.D., Senior Manager Translational Pharmacology at Immunic, will present preclinical data on the potent anti-inflammatory activity of
vidofludimus calcium (IMU-838), the company's selective oral DHODH inhibitor, at the 17th Congress of European Crohn's and
Colitis Organization (ECCO).
The poster, entitled, "Vidofludimus Calcium
(IMU-838), a Small Molecule DHODH Inhibitor in Phase 2 Clinical Trial for Ulcerative Colitis, Shows Potent Anti-inflammatory Activity
in Cell-Culture-Based Systems" (Abstract Number: EC22-1109, Poster Number: P064), will be presented during the Virtual Poster
Exhibition - Basic Science / ePosters being held today. The poster presentation will also be accessible on the "Events and
Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.
Additionally, Immunic announces the blinded baseline
characteristics of its phase 2 CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe UC. In
October 2021, Immunic announced the completion of enrollment of the trial. At completion of patient recruitment, the trial had randomized
a total of 263 patients into four arms: three active dosing arms of 10 mg, 30 mg and 45 mg, as well as placebo. Top-line data for the
induction phase is expected to be available in June of 2022.
The main blinded baseline characteristics of
the CALDOSE-1 trial include:
believes that these blinded baseline characteristics of randomized patients and the methodology regarding endoscopic assessments contributes
to ensuring an optimized study read-out.
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 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. Vidofludimus calcium was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in
a phase 2 trial in patients with ulcerative colitis. In the third quarter of 2020, the company reported positive
results from its phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting multiple
sclerosis, achieving both primary and key secondary endpoints with high statistical significance. In the first quarter of 2021,
Immunic announced that vidofludimus calcium showed evidence of clinical activity in its phase 2 CALVID-1 trial in hospitalized patients
with moderate COVID-19. Also, in the first quarter of 2021, the company reported positive top-line data from an investigator-sponsored
phase 2 proof-of-concept clinical trial of vidofludimus calcium in primary sclerosing cholangitis which was conducted in collaboration
with Mayo Clinic. To date, vidofludimus calcium has been tested in more than 800 individuals and has shown an attractive pharmacokinetic,
safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country.
(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, ulcerative
colitis, Crohn's disease, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor ROR /ROR t,
is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barr syndrome. 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.
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, 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, including multiple sclerosis,
ulcerative colitis, Crohn's disease and primary sclerosing cholangitis; preclinical and clinical data for vidofludimus calcium;
the timing of current and future clinical trials; the availability, safety or efficacy of potential treatment options for patients with
ulcerative colitis or other conditions, if any; the potential availability and frequency of administration of vidofludimus calcium as
a potential treatment for patients with ulcerative colitis or for patients with other conditions; 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, 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, 2020, filed with the SEC on February 26, 2021, 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.
Head of Investor Relations and Communications
Rx Communications Group