SAN DIEGO, June 24, 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 Hella Kohlhof, Ph.D.,
Chief Scientific Officer of Immunic, will present today previously
unpublished data regarding the company's lead program, IMU-838, at
the GI Inflammatory Diseases Summit (GIIDS) in Boston. The presentation, entitled, "IMU-838
in Clinical Phase 2 – New Selective Oral Treatment for IBD," will
take place at 3:30 pm ET. IMU-838,
currently in phase 2 clinical development for the treatment of
ulcerative colitis (UC) and relapsing-remitting multiple sclerosis
(RRMS), 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).
Highlights of Dr. Kohlhof's presentation will include these
newly released findings:
- Preclinical data shows that IMU-838 appears selective towards
those T cells producing high amounts of the pro-inflammatory
cytokines, IFNγ and IL-17.
- In mixed lymphocyte reaction assays in combination with the
anti-TNFa antibody infliximab, IMU-838 was shown to act
synergistically with regard to the induction of regulatory
macrophages, important for the efficacy of such anti-TNFa
antibodies.
- In addition to previous inflammatory bowel disease animal
models, IMU-838 also demonstrated activity in a therapeutic animal
colitis model with improvement of diarrhea score and significant
TNFa reduction in the gut.
Dr. Kohlhof's presentation will also highlight the following
advantages of IMU-838:
- As a DHODH intrinsic effect, IMU-838 is, in-vitro, able to
inhibit reactivation of several viruses. Other immunosuppressive
drugs used for the treatment of inflammatory bowel disease and
multiple sclerosis are known to have virus reactivation as one of
the clinically significant adverse drug effects.
- In comparison to other DHODH inhibitors, IMU-838 does not
target any kinases and does not exhibit an increased rate of side
effects, such as diarrhea, alopecia, or neutropenia. Notably, these
attributes do not seem to be a class effect of DHODH inhibitors. No
signal for an increased rate of liver enzyme elevation has been
seen, to date, in the clinical trials. With a terminal half-life of
30 hours in blood plasma, IMU-838 is well suited for convenient,
once daily oral dosing, reaching steady state exposure after 5-7
days of treatment and washing out within 10-14 days in most
patients.
- In a phase 2a clinical study in steroid dependent UC and
Crohn's disease patients, the active moiety of IMU-838
(vidofludimus) has shown activity in the ability to wean off
steroids, with a total response rate of 88.5%.
"The data we have generated thus far for IMU-838 remains
encouraging and supports our thesis that it may represent a
potential new, best-in-class, oral treatment for patients with UC,
RRMS and other underserved immunologic diseases," stated Dr.
Kohlhof. "In particular, we are pleased to report previously
unpublished data confirming the drug's activity in key preclinical
models, as well as evidence of its potency on high producer T cells
and ability to work in a symbiotic fashion with today's
anti-TNFa antibodies such as infliximab."
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 ulcerative colitis and relapsing-remitting
multiple sclerosis. Immunic intends to initiate an additional phase
2 trial in patients with Crohn's disease later in 2019.
Furthermore, Immunic's collaboration partner, Mayo Clinic, plans to
start 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 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 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 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 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. 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
View original content to download
multimedia:http://www.prnewswire.com/news-releases/immunic-inc-to-present-previously-unpublished-data-regarding-lead-program-imu-838-at-the-gi-inflammatory-diseases-summit-in-boston-300873182.html
SOURCE Immunic, Inc.