SAN DIEGO, Oct. 10, 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 the final patient was enrolled and randomized today
in the company's phase 2 EMPhASIS trial of IMU-838 for the
treatment of relapsing-remitting multiple sclerosis (RRMS). Patient
enrollment was completed well ahead of the original trial schedule.
As previously announced, enrollment and randomization of the last
patient had been expected during the first half of 2020.
"Achievement of this milestone for our lead program, IMU-838, in
RRMS, substantially ahead of prior expectations, reflects not only
our team's strength in executing on the company's drug development
strategy, but also the urgent need from patients for a safer oral
treatment option," stated Daniel
Vitt, Ph.D., Chief Executive Officer and President of
Immunic. "Backed by newly released preclinical data confirming the
superior profile of IMU-838 versus the currently approved DHODH
inhibitor, teriflunomide, we remain highly enthusiastic about the
potential of IMU-838 to become an important new best-in-class oral
therapeutic treatment alternative for patients with RRMS."
The phase 2 EMPhASIS trial is an international, multicenter,
double-blind, placebo-controlled, randomized, parallel-group study
that enrolled 210 patients in 36 centers across four European
countries, compared with a targeted enrollment of 195 patients. All
enrolled patients were required to have shown disease activity
based on clinical evidence of relapse and magnetic resonance
imaging (MRI) criteria. The study's primary objective is to
evaluate the dose response of 30 mg/day and 45 mg/day of IMU-838,
once daily, for the treatment of RRMS based on MRI assessments. The
primary endpoint is the cumulative number of combined unique active
(CUA) MRI lesions, up to week 24. The study also includes an
optional extended treatment period to evaluate long-term safety and
tolerability. The data will be unblinded after all patients have
completed the main treatment portion and the study database has
been locked. Management continues to anticipate top-line data
becoming available during the third quarter of 2020.
For more information on this clinical trial, please visit:
www.clinicaltrials.gov, NCT03846219.
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. 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. Immunic also intends to initiate an
additional phase 2 trial in patients with Crohn's disease.
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 RORĪ³t; 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 to safely and effectively target diseases;
preclinical and clinical data for IMU-838; the timing of current
and 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. 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
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SOURCE Immunic, Inc.