SAN DIEGO, Aug. 12, 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, today announced enrollment of the first patient in an
investigator-sponsored proof-of-concept clinical trial of IMU-838
for the treatment of patients with primary sclerosing cholangitis
(PSC). 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). PSC is a progressive disease of the liver
with unknown cause and a prevalence of about 4.15 per 100,000 in
the United States. Other than
liver transplantation, there are currently no approved therapies
that have been shown to improve survival in patients with PSC.
Keith Lindor, M.D., Senior
Advisor to the Provost and Professor of Medicine, College of Health
Solutions, Arizona State University,
and Principal Investigator for the trial, was awarded a grant from
the National Institutes of Health (NIH) for the study. The study
will be sponsored by Elizabeth
Carey, M.D., Professor of Medicine, Division of
Gastroenterology and Hepatology, Department of Internal Medicine,
Mayo Clinic, who has received Investigational New Drug (IND)
approval from the U.S. Food & Drug Administration (FDA) and has
been granted Institutional Review Board (IRB) approval to conduct
the study. The study will be conducted at Mayo Clinic in
Arizona (Dr. Carey) and
Minnesota (John E. Eaton, M.D.), both of which are tertiary
care centers for PSC patients.
The proof-of-concept study, for which Immunic is providing the
study medication, is a single-arm, open-label, exploratory study
planning to enroll a total of 30 patients with PSC, aged 18 to 75
years, who will receive 30mg IMU-838 once daily for a period of six
months. The trial's primary endpoint is the change in serum
alkaline phosphatase (ALP) at six months compared to baseline. In
previous trials, a biochemical endpoint such as change in serum ALP
has been an accepted biomarker of disease progression in PSC
patients.
Dr. Keith Lindor commented,
"Recent studies indicate that the proinflammatory cytokine
interleukin 17, or IL-17, may play a central role in the
pathogenesis of PSC, as well as ulcerative colitis. Significant
increases in IL-17-expressing lymphocytes are found in the livers
of PSC patients. These findings speak to the strong possibility of
an overlap in therapeutic approaches to the two diseases. Our goal
with this study is to examine the safety, tolerability, and
efficacy of daily dosing of IMU-838, an orally available, small
molecule inhibitor of DHODH, a target known for its effect on Th17
cells, in order to establish proof-of-concept that IMU-838 shows
activity for the treatment of PSC. Establishing such a baseline
should enable the design of more comprehensive clinical
studies."
"We are honored to be collaborating with such prominent
institutions and investigators, including Drs. Lindor, Carey and
Eaton on this important clinical trial," noted Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "Certainly, the available data, including the
mode of action of IMU-838, which already is commercially proven in
other indications, compels us to support their work to address the
unmet medical need of patients affected by PSC, whose current
options include only supportive care or, ultimately, liver
transplantation. With the potential for a best-in-class DHODH
inhibitor safety profile, and an IND for IMU-838 in inflammatory
bowel disease, or IBD, already established, positive data from this
investigator-sponsored trial should enable Immunic to approach the
regulatory authorities about the possibility of an accelerated
regulatory pathway in this orphan indication."
For more information on this clinical trial, please visit:
www.clinicaltrials.gov, NCT03722576.
About Primary Sclerosing Cholangitis (PSC)
PSC is a
very rare liver disease with a prevalence of about 4.15 per 100,000
in the United States, in which the
bile ducts in the liver become inflamed, narrow and prevent bile
from flowing properly. The exact cause and disease mechanism are
still unknown but an autoimmune mechanism may play a role. There is
an association with inflammatory bowel diseases, most often with
ulcerative colitis and less commonly with Crohn's disease. PSC is a
progressive disease and the estimated time from diagnosis of PSC to
death or liver transplant has been shown to be less than 15
years.
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 intends to initiate an additional phase
2 trial in patients with Crohn's disease later in 2019.
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 in Crohn's
disease planned for the second half of 2019. 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
the potential for IMU-838, IMU-935 and IMU-856 to safely and
effectively target diseases; the proof-of-concept study of IMU-838
for the treatment of patients with primary sclerosing cholangitis;
the potential accelerated regulatory pathway of IMU-838; Immunic's
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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SOURCE Immunic, Inc.