NEW YORK, July 1, 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 U.S. Food and Drug Administration (FDA) clearance of its
Investigational New Drug (IND) application for the phase 3
ENSURE program of lead asset IMU-838, the company's selective oral
DHODH inhibitor, in patients with relapsing-remitting multiple
sclerosis (RRMS). In addition, the FDA also cleared the company's
separate IND application for the supportive phase 2 CALLIPER
trial of IMU-838 in patients with progressive multiple sclerosis
(PMS).
The ENSURE program comprises two multicenter, randomized,
double-blind phase 3 trials designed to evaluate the efficacy,
safety, and tolerability of IMU-838 versus placebo in RRMS
patients. Based on IMU-838's robust activity in preventing lesion
formation in the company's phase 2 EMPhASIS trial in RRMS, the
strong and consistent correlation observed between lesion formation
and clinical relapse in third-party clinical trials, and the drug's
robust safety profile to date, Immunic believes that this phase 3
program provides a simple and straightforward path towards
potential regulatory approval of IMU-838 in RRMS.
The multicenter, randomized, double-blind, placebo-controlled
phase 2 CALLIPER trial is intended to run concurrently with and to
complement the phase 3 program in RRMS. In particular, CALLIPER is
focused on progressive forms of multiple sclerosis (MS) and
designed to corroborate IMU-838's neuroprotective potential, as
exemplified by slowing of brain atrophy and delay in disability
worsening. Neurodegeneration is a key concern in both PMS and RRMS,
since axonal and neural damage is responsible for the increasing
and often severe disability experienced by patients. Immunic
believes that, if the CALLIPER trial is successful in showing a
beneficial effect of IMU-838, this data, along with the ENSURE
program and IMU-838's strong safety and tolerability profile, may
allow for a meaningful clinical differentiation of IMU-838 from
other oral MS medications and an attractive commercial positioning.
Although a supportive trial, Immunic does not believe that data
from the CALLIPER trial are a pre-condition for filing a New Drug
Application in RRMS.
"IMU-838's phase 2 results in relapsing-remitting multiple
sclerosis showed an encouraging balance between efficacy, safety,
and tolerability and I look forward to the phase 3 program in this
indication," commented Robert J.
Fox, M.D., Staff Neurologist, Mellen Center for Multiple
Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland
Clinic, Cleveland, Ohio, and
Coordinating Investigator of the ENSURE and CALLIPER
programs. "Disability progression is a principal concern for
clinicians and patients of both PMS and RRMS. The ongoing
disability worsening, even in periods without relapse, not only
diminishes quality-of-life but can also ultimately lead to profound
impairments in patient mobility. There is a clear unmet need for
new therapeutic options which can help delay or arrest this process
and I look forward to seeing data on IMU-838's neuroprotective
potential." Dr. Fox receives compensation as a chair of the
steering committees for the ENSURE and CALLIPER programs.
"IND clearance for our phase 3 program in RRMS is yet another
seminal moment for Immunic as it progresses our lead asset,
IMU-838, into a pivotal program and heralds the final phase of
clinical development in MS. We believe that the phase 3 ENSURE
program meaningfully simplifies IMU-838's regulatory approval path
in MS as it applies a very clean and straightforward study design,"
stated Daniel Vitt, Ph.D., Chief
Executive Officer and President of Immunic. "In addition,
together with our MS expert panel, we designed the CALLIPER trial
to study patients who currently are not typically treated with
relapse preventing therapies. Our goal is to highlight IMU-838 as a
therapy that combines truly differentiated safety and tolerability
with neuroprotective activity such as slowing of brain atrophy and
disability worsening. In our view, success in the CALLIPER trial
could provide an important differentiator for IMU-838 in the MS
market. We look forward to hopefully providing IMU-838 as an
important new therapeutic option to MS patients within the next few
years."
Each of the identical twin phase 3 trials, titled ENSURE-1 and
ENSURE-2, is expected to enroll approximately 1,050 adult patients
with active RMS at more than 100 sites in 14 countries, including
the United States, Latin America, Central and Eastern Europe, and India. Patients will be randomized in a
double-blinded fashion to either 30 mg daily doses of IMU-838 or
placebo and the primary endpoint for both trials is time to first
relapse up to 72 weeks. Key secondary endpoints include volume of
new T2-lesions, time to confirmed disability progression, time to
sustained clinically relevant changes in cognition, and percentage
of whole brain volume change, grey matter volume, and white matter
volume. With regard to the disability progression endpoint, the
ENSURE program applies a pooled analysis of disability worsening
across both trials, which may be further supported by data from the
CALLIPER trial.
The ENSURE trials will be run concurrently, with dosing of the
first patient expected in the second half of 2021. An interim
analysis to assess event rates is planned to occur after a certain
number of relapses have occurred in the double-blind treatment
periods. This analysis is intended to inform potential sample size
adjustment and help ensure that final study readout is not planned
to occur before sufficient events have been achieved. This interim
analysis is not intended as a futility analysis.
The phase 2 CALLIPER trial is 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 in a
double-blinded fashion. 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). Dosing of the
first patient is expected in the third quarter of 2021.
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. NfL has been shown consistently to 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. As previously reported, results of the phase 2
EMPhASIS trial of IMU-838 in RRMS showed a robust decrease in serum
NfL at 24 weeks (-17.0% for 30 mg and -20.5% for 45 mg), as
compared to baseline values, while the patients on placebo
experienced a 6.5% increase in serum NfL over the same period.
"The Immunic team is very excited to see IMU-838 progressing
into a pivotal program in RRMS. Based on its very strong safety and
tolerability profile along with its robust efficacy, which we are
planning to further highlight with neuroprotective data from the
CALLIPER trial, we believe that IMU-838 has the potential to become
a well-differentiated new treatment option for MS patients," added
Andreas Muehler, M.D., Chief
Medical Officer of Immunic. "In our discussions with regulatory
authorities, including the FDA and the European Medicines Agency,
testing IMU-838 against placebo was viewed as a reasonable approach
for our phase 3 program, from both a regulatory and scientific
perspective, as placebo provides the cleanest comparator to show
proof-of-efficacy and to underline IMU-838's existing safety and
tolerability profile."
Conference Call and Webcast Information
Immunic's management team will host a public conference call and
webcast on July 1, 2021 at 8:00
a.m. Eastern Time to discuss the company's overall MS
development strategy, the phase 3 ENSURE program in RRMS, and the
phase 2 CALLIPER trial in PMS.
To participate in the conference call, dial 1-877-870-4263
(USA) or 1-412-317-0790
(International) and ask to be joined into the Immunic, Inc. call. A
live, listen-only webcast of the conference call can be accessed at
https://www.webcaster4.com/Webcast/Page/2301/39951 or on the
"Events and Presentations" section of Immunic's website at
ir.imux.com/events-and-presentations.
An archived replay of conference call and webcast will be
available approximately one hour after the completion for one year
on Immunic's website at: ir.imux.com.
About 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. MS affects approximately one
million people in the United
States, and more than 2.8 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.
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.
Progressive MS (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 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,
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 or 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 relapsing-remitting
or progressive multiple sclerosis or other conditions, if any; the
potential availability and frequency of administration of IMU-838
as a potential treatment for patients with relapsing-remitting or
progressive 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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