NEW YORK, April 15, 2021 /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, today announced interim data from Cohort 2 of its phase 2
EMPhASIS trial of IMU-838 in relapsing-remitting multiple sclerosis
(RRMS). Immunic has concluded from this data, along with previously
published data from Cohort 1, that 30 mg once daily IMU-838 is
the most appropriate dose for future phase 3 trials in patients
with RRMS. In support, Immunic notes that both the 30 mg and 45 mg
dosing groups of IMU-838 in Cohort 1 performed equivalently
regarding efficacy-related endpoints and there was no safety signal
for either dosing group, as compared to placebo.
The second cohort of the EMPhASIS trial was designed to confirm
that a dose lower than the 30 mg and 45 mg daily dose groups
studied in the first cohort was unlikely to match the efficacy seen
in these higher doses, thus enabling a straightforward and simpler
phase 3 design. As anticipated, the 10 mg dose of IMU-838
proportionally showed less magnetic resonance imaging (MRI) lesion
suppression in RRMS than the previously published results of the 30
mg and 45 mg doses of IMU-838. In particular, the 10 mg dose of
IMU-838 in Cohort 2 demonstrated a placebo-adjusted reduction of
32% and 40% in combined unique active and gadolinium-enhancing MRI
lesions at week 12, respectively. This result is numerically lower
than the analogous reduction in MRI lesions observed in the 30 mg
and 45 mg IMU-838 dosing arms of Cohort 1 at week 12, which ranged
between 62% and 75%. Collectively, Immunic believes that these data
demonstrate a clear dose-response pattern for IMU-838 in RRMS. The
Cohort 2 interim analysis was performed after 59 randomized
patients, receiving either 10 mg of IMU-838 or placebo once daily,
completed week 12 MRI assessments. All Cohort 2 patients continue
to be treated and will proceed to complete their 24-week blinded
treatment.
Immunic remains in discussions with regulatory authorities,
including the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency, regarding the planned phase 3 program in
RRMS. At the FDA's request, Immunic plans to proceed directly to
submitting an Investigational New Drug (IND) application, instead
of holding an end-of-phase 2 meeting. As previously announced,
feasibility and other preparatory activities for the phase 3
program are already ongoing and initiation is expected in the
second half of 2021.
"The positive outcome of the interim analysis of our Cohort 2
sub-trial of IMU-838 in RRMS further strengthens our understanding
of the dose-response relationship of IMU-838. The 10 mg interim
data and its comparison to the already available 30 mg and 45 mg
data provides additional support to address potential regulatory
requests in the context of the design and execution of our phase 3
program," commented Andreas Muehler,
M.D., Chief Medical Officer of Immunic. "Based on all available
data, we believe that the dose of 30 mg once daily IMU-838 should
be considered the most appropriate dose for RRMS patients. While we
continue our discussions with major regulatory authorities, we will
move ahead with formal phase 3 feasibility activities."
"Reporting of this Cohort 2 sub-trial analysis, on time and with
results fully matching our expectations, is a testament to the
strength of our scientific and clinical teams," stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "We look forward to announcing details for
the design of our phase 3 program, which we intend to initiate in
the second half of this year, as soon as the final regulatory
feedback is available. Data thus far continues to convince us that
IMU-838 may become an important, new, oral therapeutic option with
an outstanding combination of safety, tolerability and robust
efficacy for the treatment of patients suffering from RRMS, and we
are eager to move ahead with its final clinical development
steps."
About Relapsing-Remitting 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. Relapsing-remitting MS (RRMS) is the
most common form of the disease. Approximately 85% of patients with
MS are expected to develop RRMS, with some of these patients later
developing more progressive forms of the disease. RRMS is
characterized by clearly defined attacks of new or increasing
neurologic symptoms. These relapses are followed by periods of
remission, or partial or complete recovery. During remissions, all
symptoms may disappear, or some symptoms may continue and become
permanent. MS is a progressive disease which, without effective
treatment, leads to severe disability. MS affects more than
700,000 people in the United
States, and more than 2.2 million people
worldwide. The disease mainly affects young adults of prime
working age, although MS can occur at any age. MS is at least two
to three times more common in women than in men.
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 aimed at 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, COVID-19, and
primary sclerosing cholangitis. IMU-935, a selective inverse
agonist of the transcription factor RORγt, is targeted for
development in psoriasis 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 relating to Immunic's three development programs and the
targeted diseases; the potential for IMU-838 to safely and
effectively target diseases, including relapsing-remitting 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
relapsing-remitting multiple sclerosis or other conditions, if any,
that may be supported by the company's phase 2 EMPhASIS trial data;
future analysis of the EMPhASIS trial data and presentations
related thereto; the potential availability and frequency of
administration of IMU-838 as a potential treatment for patients
with relapsing-remitting multiple sclerosis or for patients with
other conditions; preparations for a clinical phase 3 program for
IMU-838 in relapsing-remitting multiple sclerosis; 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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