NEW YORK, Oct. 27, 2021 /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 announced enrollment of the first psoriasis patient
in Part C of its ongoing phase 1 clinical trial of IMU-935, a
highly potent and selective inverse agonist of the transcription
factor RORγt.
Part C is structured as a 28-day, double-blind,
placebo-controlled trial designed to enroll approximately 52
patients, randomized 3:1 versus placebo with two treatment cohorts.
The primary objective is to evaluate the safety and tolerability of
IMU-935 in moderate-to-severe psoriasis patients. Secondary
objectives include evaluation of trough plasma concentration levels
and effects on skin symptoms utilizing the Psoriasis Area and
Severity Index (PASI), Dermatology Life Quality Index (DLQI),
psoriasis affected body surface area (BSA), Physicians Global
Assessment (PGA), and Itch Numeric Rating Scale (NRS). The trial
also assesses pharmacodynamic marker changes, including serum
cytokines, ex vivo peripheral blood mononuclear
cell gene expression profiles and histological biomarker analysis
in skin biopsies. More than 10 sites in Australia and New
Zealand are expected to participate in Part C.
"The initiation of treatment of patients with active disease
with IMU-935 marks a significant milestone in the continued
advancement of our development pipeline," stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "We chose to target psoriasis as we strongly
believe that it provides an ideal pathophysiology to assess safety
as well as biomarkers related to IMU-935's mechanism of action. In
addition, we believe that there is an urgent medical need to
translate the significant therapeutic advances in IL17-targeted
therapies in psoriasis into a more convenient oral treatment option
for patients. We also eagerly await completion of the single and
multiple ascending dose parts of this phase 1 trial in healthy
volunteers later in 2021, which, if successful in showing a
favorable safety and pharmacokinetic profile for IMU-935, should
bolster our thesis behind this program and allow us to further
progress with our development plan."
"RORγt is a target that has generated a great deal of interest
in the scientific and medical community, given its potential to
restore the balance between pro-inflammatory and regulatory
lymphocytes, and to modulate a range of cytokines involved in
various immune-mediated diseases," added Hella Kohlhof, Ph.D., Chief Scientific Officer
of Immunic. "Based on preclinical and clinical data generated thus
far, we continue to believe that IMU-935 has the potential to be a
best-in-class, orally available, and potent IL-17 inhibitor for the
safe and efficacious treatment of the millions of patients affected
by autoimmune diseases, worldwide."
About IMU-935
IMU-935 is a highly potent and selective
inverse agonist of RORγt (retinoic acid receptor-related orphan
nuclear receptor gamma truncated) with additional activity on DHODH
(dihydroorotate dehydrogenase). The nuclear receptor RORγt
is believed to be the main driver for the differentiation of
Th17 cells and the expression of cytokines involved in various
inflammatory and autoimmune diseases. This target is believed to be
an attractive alternative to approved antibodies for targets such
as IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows strong
cytokine inhibition targeting both Th17 and Th1 responses in
preclinical testing, as well as indications of activity in animal
models for psoriasis and inflammatory bowel disease. Preclinical
experiments indicate that, while leading to a potent inhibition of
Th17 differentiation and cytokine secretion, IMU-935 did not affect
thymocyte maturation. IMU-935 is an investigational drug product
that has not been approved in any jurisdiction.
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,
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 RORγt, is targeted for development in
psoriasis, castration-resistant prostate cancer and Guillain-Barré
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.
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, 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 IMU-935 to safely and effectively target diseases;
preclinical and clinical data for IMU-935; the timing of current
and future clinical trials; 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 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 resources to meet business objectives
and operational requirements, the fact that the results of earlier
studies and 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.
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
+1 917 322 2216
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
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SOURCE Immunic, Inc.