SAN DIEGO, Sept. 11, 2019 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical
company focused on developing potentially best-in-class, oral
therapies for the treatment of chronic inflammatory and autoimmune
diseases, announced that Andreas
Muehler, M.D., Chief Medical Officer of Immunic, will
present today selected available and previously unpublished
preclinical data summarizing the profile of its lead oral compound,
IMU-838, as compared to the dihydroorotate dehydrogenase
(DHODH) inhibitor, teriflunomide, at the Congress of the
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) 2019 in Stockholm,
Sweden. The poster will be presented during Poster Session 1
being held today, from 5:15 pm to 7:15 pm
CEST. IMU-838, in phase 2 development for
relapsing-remitting multiple sclerosis (RRMS) and ulcerative
colitis, is a novel, orally available, next-generation selective
immune modulator that inhibits the intracellular metabolism of
activated immune cells by blocking DHODH.
The poster, entitled, "The DHODH Inhibitor
IMU-838/Vidofludimus Calcium Shows a Superior Compound
Profile as Compared to the Approved DHODH Inhibitor,
Teriflunomide," co-authored by Dr. Muehler, Hella Kohlof, Ph.D., Chief Scientific Officer of
Immunic, Manfred Gröppel, Ph.D., Chief Operating Officer of Immunic
and Daniel Vitt, Ph.D., Chief
Executive Officer and President of Immunic, highlights the
favorable profile of IMU-838 regarding safety, biological
selectivity, pharmacokinetics and potency, as compared to
teriflunomide. Highlights of Dr. Muehler's presentation will
include these selected and previously unpublished findings:
- Selectivity for DHODH, and IMU-838's lack of off-target effects
on kinases were confirmed;
- IMU-838 showed a strong cytokine inhibition on stimulated human
peripheral blood lymphocytes;
- IMU-838's short blood half-life of approximately 30 hours
should make it favorable for once-daily dosing, as well as rapid
wash-out, if needed;
- Treatment with IMU-838 results in fast onset, reaching steady
state concentrations within 5 to 7 days;
- Dosing in humans did not result in increased rates of diarrhea,
alopecia or neutropenia, as compared to placebo;
- Due to biological selectivity, the molecule has no general
antiproliferative effect on immune cells.
"These previously unpublished data, which we believe
illustrate a superior profile compared to teriflunomide, serve to
bolster our dossier on IMU-838, and offer further support for our
belief in its potential to become an important new, best-in-class,
oral therapeutic option for patients with RRMS and other
immunologic diseases," stated Dr. Muehler. "We are honored to
present this additional compelling data at the ECTRIMS 2019
Congress, giving us an important opportunity to talk directly to
the scientific community about our lead, phase 2 pipeline
program."
About IMU-838
IMU-838 is an orally available,
next-generation selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts 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, IMU-838 did not show an
increased rate of infections compared to placebo. In addition,
DHODH inhibitors such as IMU-838 are known to possess a direct
antiviral effect. IMU-838 was successfully tested in two phase 1
clinical trials in 2017 and is currently being tested in phase 2
trials in patients with relapsing-remitting multiple sclerosis and
ulcerative colitis. Immunic also intends to initiate an additional
phase 2 trial in patients with Crohn's disease. Furthermore,
Immunic's collaboration partner, Mayo Clinic, has started an
investigator-sponsored proof-of-concept clinical trial testing
IMU-838 activity in patients with primary sclerosing
cholangitis.
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 relapsing-remitting
multiple sclerosis, ulcerative colitis, Crohn's disease, 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 RORγt; 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 relapsing-remitting multiple sclerosis and
ulcerative colitis, with an additional phase 2 trial planned in
Crohn's disease. An investigator-sponsored proof-of-concept
clinical trial for IMU-838 in primary sclerosing cholangitis is
ongoing 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 and clinical data for
IMU-838; 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. A further list and descriptions of these risks,
uncertainties and other factors can be found in the section
captioned "Item 1A. Risk Factors," in the company's Current Report
on Form 8-K filed on July 17, 2019,
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.immunic-therapeutics.com/sec-filings and on
request from Immunic. 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
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
View original content to download
multimedia:http://www.prnewswire.com/news-releases/immunic-inc-to-present-selected-available-and-previously-unpublished-data-regarding-lead-program-imu-838-at-the-congress-of-the-european-committee-for-treatment-and-research-in-multiple-sclerosis-2019-300915842.html
SOURCE Immunic, Inc.