NEW YORK, Sept. 30, 2021 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a clinical-stage
biopharmaceutical company developing a pipeline of selective oral
immunology therapies focused on treating chronic inflammatory and
autoimmune diseases, today announced enrollment of the first
patient in its phase 2 CALLIPER trial of lead asset IMU-838, the
company's selective oral DHODH inhibitor, in patients with
progressive multiple sclerosis (PMS). The trial, which is
intended to run concurrently with and as a complement to the
company's twin phase 3 ENSURE trials in relapsing-remitting
multiple sclerosis (RRMS), is focused on progressive forms of
multiple sclerosis (MS) and designed to corroborate IMU-838's
neuroprotective potential in this patient population.
CALLIPER is an international, multicenter, randomized,
double-blind, placebo-controlled phase 2 trial expected to enroll
approximately 450 patients at more than 70 sites in North America, Western, Central and
Eastern Europe, with patients
randomized to either 45 mg daily doses of IMU-838 or placebo. The
trial's primary endpoint is the annualized rate of percent brain
volume change up to 120 weeks. Key secondary endpoints include the
annualized rate of change in whole brain atrophy and time to
24-week confirmed disability progression based on the expanded
disability status scale (EDSS). An interim analysis comprising an
unblinded analysis of serum neurofilament light chain (NfL) is
planned to occur once approximately half of the enrolled patients
have completed 24 weeks of treatment.
"Enrollment of the first PMS patient in our phase 2 CALLIPER
trial, on schedule, is another important clinical milestone for our
lead asset, IMU-838, and we continue to anticipate initiating our
phase 3 ENSURE program in RRMS patients in the fourth quarter of
this year," stated Daniel Vitt,
Ph.D., Chief Executive Officer and President of Immunic. "We
believe that if the CALLIPER trial is successful in showing a
beneficial neuroprotective effect of IMU-838, this data, along with
that of the ENSURE program and IMU-838's already proven, strong
safety and tolerability profile, may allow us to draw a clear
clinical differentiation for IMU-838 versus other oral MS
medications, resulting in an attractive commercial positioning as a
transformative therapeutic treatment."
"The CALLIPER trial is designed to further explore IMU-838's
neuroprotective potential, as exemplified by a slowing of brain
atrophy and delay in disability worsening, which is often caused by
axonal and neural damage," added Andreas
Muehler, M.D., Chief Medical Officer of Immunic. "The
interim analysis to assess NfL is key, as it has been shown to
consistently correlate with disease activity in neurological
disorders and has become one of the most important serum biomarkers
for axonal damage over the past few years. If the CALLIPER trial is
successful in showing beneficial data, we believe this could be an
essential differentiator for IMU-838 in the MS market."
For more information on this clinical trial, please visit:
www.clinicaltrials.gov, NCT05054140.
About Progressive Multiple Sclerosis
Multiple
sclerosis (MS) is an autoimmune disease that affects the brain,
spinal cord and optic nerve. In MS, myelin, the coating that
protects the nerves, is attacked and damaged by the immune system.
Thus, MS is considered an immune-mediated demyelinating disease of
the central nervous system. Progressive multiple sclerosis (PMS)
includes both primary progressive MS (PPMS) and secondary
progressive MS (SPMS). PPMS is characterized by steadily worsening
neurologic function from the onset of symptoms without initial
relapse or remissions. SPMS is identified following an initial
relapsing remitting course, after which the disease becomes more
steadily progressive, with or without other disease activity
present.
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
host-based antiviral effect, which is independent with respect to
specific virus proteins and their structure. Therefore, DHODH
inhibition may be broadly applicable against multiple viruses.
IMU-838 was successfully tested in two phase 1 clinical trials in
2017 and is currently being tested in a phase 2 trial in patients
with ulcerative colitis. In the third quarter of 2020, the company
reported positive results from its phase 2 EMPhASIS trial of
IMU-838 in relapsing-remitting multiple sclerosis, achieving both
primary and key secondary endpoints with high statistical
significance. In the first quarter of 2021, Immunic announced that
IMU-838 showed evidence of clinical activity in its phase 2
CALVID-1 trial in hospitalized patients with moderate COVID-19.
Also, in the first quarter of 2021, the company reported positive
top-line data from an investigator-sponsored phase 2
proof-of-concept clinical trial of IMU-838 in primary sclerosing
cholangitis which was conducted in collaboration with Mayo Clinic.
To date, IMU-838 has been tested in more than 800 individuals and
has shown an attractive pharmacokinetic, safety and tolerability
profile. IMU-838 is not yet licensed or approved in any
country.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a
clinical-stage biopharmaceutical company with a pipeline of
selective oral immunology therapies focused on treating chronic
inflammatory and autoimmune diseases. The company is developing
three small molecule products: its lead development program,
IMU-838, a selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme DHODH and exhibits a host-based antiviral effect, is
currently being developed as a treatment option for multiple
sclerosis, ulcerative colitis, Crohn's disease, and primary
sclerosing cholangitis. IMU-935, a selective inverse agonist of the
transcription factor RORγt, is targeted for development in
psoriasis, castration-resistant prostate cancer and Guillain-Barré
syndrome. IMU-856, which targets the restoration of the intestinal
barrier function, is targeted for development in diseases involving
bowel barrier dysfunction. For further information, please visit:
www.imux.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,
including progressive multiple sclerosis; preclinical and clinical
data for IMU-838; the timing of current and future clinical trials;
the availability, safety or efficacy of potential treatment options
for patients with progressive multiple sclerosis or other
conditions, if any; the nature, strategy and focus of the company
and further updates with respect thereto; 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, the
COVID-19 pandemic, 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 "Risk Factors," in the company's
Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on
February 26, 2021, 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.imux.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
Head of Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1-917-322-2216
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
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SOURCE Immunic, Inc.