SAN DIEGO, June 4, 2019 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical
company focused on developing best-in-class, oral therapies
for the treatment of chronic inflammatory and autoimmune diseases,
announced that Hella Kohlhof, Ph.D.,
Chief Scientific Officer of Immunic, will present today newly
available preclinical data confirming IMU-935 as a highly potent
inhibitor of both, RORϒt and
dihydroorotate dehydrogenase (DHODH), which was shown to lead to a
strong synergism on the reduction of pro-inflammatory cytokine
release. The data also showed that IMU-935 does not affect
thymocyte maturation. In previous studies, it was hypothesized that
affecting thymocyte development may lead to the risk of developing
thymoma. Furthermore, in preclinical animal models of colitis and
psoriasis, IMU-935 also demonstrated efficacy after oral
administration. Dr. Kohlhof will present the data in a poster
presentation at the 2nd Conference on Molecular
Mechanisms of Inflammation in Trondheim, Norway, beginning today at 6:00 pm CEST.
An important hallmark of many autoimmune diseases is the
imbalance between Th17 cells and regulatory T cells. The key
transcription factor for Th17 cell differentiation and IL-17
secretion is the nuclear receptor RORϒt, widely believed to be a major switch
for the reduction of Th17 cells and cytokines involved in various
autoimmune diseases.
The poster, entitled, "Development of IMU-935, an orally
available small molecule inhibitor of IL-17 with a unique molecular
profile for the treatment of autoimmune diseases," outlines
Immunic's preclinical models, in which IMU-935 was characterized in
different in vitro and cellular assay systems as well as in in vivo
disease models, in order to demonstrate its inhibitory capacity on
RORϒt, DHODH, Th17 differentiation,
cytokine secretion and impact on autoimmune diseases, but allowing
normal thymocyte maturation.
Results confirm that IMU-935 is a potent inverse agonist of
RORϒt, with an IC50 (the
concentration of drug that inhibits 50 % of the activity of the
target) of 24 nM, with a maximum inhibition of approximately 80 %,
thereby maintaining a biologically important basal activity at any
concentration. As a second and synergistic acting target, IMU-935
was shown to inhibit DHODH with an IC50 of 240 nM. The
combined effects lead to a very potent inhibition of the secretion
of IL-17A, IL-17F and IFNg, with IC50 concentrations of
3-5 nM tested in human PHA stimulated PBMCs. Th17 differentiation
was inhibited with an IC50 of 150 nM. Additionally, the
data showed that maintaining a basal activity of RORϒt of approximately 20 %, and at the same
time synergistically targeting DHODH, effectively leads to
inhibition of Th17 differentiation and blocking of IL-17 secretion
at very low concentrations, while maintaining normal thymocyte
maturation. Previous publications of other research groups had
hypothesized that blocking thymocyte maturation may lead to a risk
of thymoma development.
IMU-935 also demonstrated activity in a DSS (dextran sulfate
sodium) induced colitis model and in an Imiquimod induced
psoriasis-like model after oral application of the drug.
"The data are highly encouraging and confirm our belief that
IMU-935 is a very potent orally available small molecule inhibitor
of the Th17/IL-17 axis with the advantage of not affecting
thymocyte maturation, and may, therefore, represent a potential
new, best-in-class therapy for certain inflammatory and autoimmune
diseases that currently affect millions of patients, globally,"
stated Dr. Kohlhof. "We look forward to completing preclinical,
IND-enabling studies and remain on track to move IMU-935 into phase
1 double-blind, placebo-controlled, single and multiple ascending
dose trials in healthy volunteers later this year. We also plan to
extend these studies to assess safety and mechanism-related
biomarkers in patients with psoriasis."
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX)
is a clinical-stage biopharmaceutical company developing a
pipeline of selective oral immunology therapies aimed at treating
chronic inflammatory and autoimmune diseases, including ulcerative
colitis, Crohn's disease, relapsing-remitting multiple sclerosis,
and psoriasis. The company is developing three small molecule
products: IMU-838 is a selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme DHODH; IMU-935 is an inverse agonist of RORϒt; and IMU-856 targets the restoration
of the intestinal barrier function. Immunic's lead development
program, IMU-838, is in phase 2 clinical development for ulcerative
colitis and relapsing-remitting multiple sclerosis, with an
additional phase 2 trial in Crohn's disease planned for 2019. An
investigator-sponsored proof-of-concept clinical trial for IMU-838
in primary sclerosing cholangitis is planned to start at the Mayo
Clinic. For further information, please visit:
www.immunic-therapeutics.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-838, IMU-935 and IMU-856 to safely and
effectively target diseases; preclinical data for IMU-935; the
timing of future clinical trials; the nature, strategy and focus of
the company; 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, 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. 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.
Contact Information
Immunic, Inc.
Jessica Breu
Manager IR and Communications
+49 89 250 0794 69
jessica.breu@immunic.de
Or
Rx Communications Group
Melody Carey
+1-917-322-2571
immunic@rxir.com
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