– Based on a Review of Unblinded Data, an
Independent Data Monitoring Committee (IDMC) Confirmed that
Predetermined Futility Criteria Have Not Been Met –
– IDMC Also Recommended Continuing Trial
without Changes, Including no Need for a
Potential Upsizing –
– ENSURE Program Remains on Track to be
Completed in 2026 –
– Webcast to be Held Today, October 22, at 8:00 am
ET –
NEW
YORK, Oct. 22, 2024 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a biotechnology company
developing a clinical pipeline of orally administered, small
molecule therapies for chronic inflammatory and autoimmune
diseases, today announced a positive outcome of the non-binding,
interim futility analysis of its phase 3 ENSURE program,
investigating lead asset, nuclear receptor related 1 (Nurr1)
activator, vidofludimus calcium (IMU-838), for the treatment of
relapsing multiple sclerosis (RMS). Based on the outcome of the
interim futility analysis, an unblinded Independent Data Monitoring
Committee (IDMC) has recommended that the trials are not futile and
should continue as planned.
"While Immunic remains blinded to all data, the IDMC's favorable
recommendations in this interim analysis corroborate our initial
assumptions for the design, powering and relapse rate of the twin
phase 3 trials of vidofludimus calcium in RMS, and suggest that
they are in line with the data observed so far," stated
Andreas Muehler, M.D., M.B.A., Chief
Medical Officer of Immunic. "In particular, the planned sample size
seems appropriate to address the primary endpoint of time to first
relapse. As the IDMC recommends, we are continuing the ENSURE
trials unchanged, with completion expected in 2026."
"I am particularly excited about the positive outcome of the
interim analysis of our phase 3 ENSURE trials, marking the
successful achievement of a critical milestone for the program,"
added Daniel Vitt, Ph.D., Chief
Executive Officer of Immunic. "We are confident in
vidofludimus calcium's potential to transform the oral MS market
and continue to believe that the phase 3 program provides a clear
and straightforward path towards seeking potential regulatory
approval in RMS. Our next clinical milestone for vidofludimus
calcium is the top-line readout of our phase 2 CALLIPER trial in
patients with progressive multiple sclerosis (PMS), which we expect
to release in April of next year. If this data set continues to
show a neuroprotective effect for vidofludimus calcium, we believe
our drug may be positioned as first-in-class oral treatment option
for PMS, a form of MS with highest unmet medical needs."
The interim futility analysis of the phase 3 ENSURE program was
performed by an unblinded IDMC and based on a pre-specified
assessment after approximately half of the planned first relapse
events occurred in the double-blind treatment periods of each of
the twin ENSURE-1 and ENSURE-2 trials. The analysis was intended to
inform potential sample size adjustment and help prevent the
final study readout from occurring before sufficient events have
been achieved. The unblinded IDMC was asked to make two decisions:
The first question, as to whether the trials are futile, was
answered by the IDMC with "futility criteria have not been met."
The second question, as to whether the sample size in each trial
should be increased, was answered by the IDMC with "continue as
planned." Both decisions were based on the conditional power of the
trials at the time of the interim analysis. Immunic has remained
blinded during the interim analysis and has not seen any of the
data available to the IDMC to make their recommendations.
The ongoing ENSURE program comprises two identical multicenter,
randomized, double-blind phase 3 trials designed to evaluate the
efficacy, safety and tolerability of vidofludimus calcium versus
placebo in RMS patients. Each of the 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 more than 15 countries,
including the United States,
India and countries in
Latin America, Central and
Eastern Europe. Patients are being
randomized in a double-blinded fashion to either 30 mg daily doses
of vidofludimus calcium or placebo and the primary endpoint for
both trials is time to first relapse up to 72 weeks. Key secondary
endpoints include time to confirmed disability worsening based on
Expanded Disability Status Scale (EDSS) disability progression,
volume of new T2-lesions, time to sustained clinically relevant
changes in cognition, and percentage of whole brain volume change,
grey matter volume and white matter volume. As previously reported,
completion of ENSURE-1 is anticipated in the second quarter of
2026, with completion of ENSURE-2 expected in the second half of
2026.
Webcast Information
Immunic will host a webcast today
at 8:00 am ET. To participate in the
webcast, please register in advance at:
https://imux.zoom.us/webinar/register/WN_fSJNHWuxRMGRPaMl3hUlqg or
on the "Events and Presentations" section of Immunic's website at:
ir.imux.com/events-and-presentations. Registrants will receive a
confirmation email containing a link for online participation or a
telephone number for dial-in access.
An archived replay of the webcast will be available
approximately one hour after completion on Immunic's website at:
ir.imux.com/events-and-presentations.
About Vidofludimus Calcium (IMU-838)
Vidofludimus
calcium is a small molecule investigational drug in development as
an oral next-generation treatment option for patients with multiple
sclerosis and other chronic inflammatory and autoimmune diseases.
The selective immune modulator activates the neuroprotective
transcription factor nuclear receptor related 1 (Nurr1), which is
associated with direct neuroprotective properties. Additionally,
vidofludimus calcium is a highly selective inhibitor of the enzyme
dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the
metabolism of overactive immune cells and virus-infected cells.
This mechanism is associated with the anti-inflammatory and
anti-viral effects of vidofludimus calcium. Vidofludimus calcium
has been observed to selectively act on hyperactive T and B cells
while leaving other immune cells largely unaffected and enabling
normal immune system function, e.g., in fighting infections. To
date, vidofludimus calcium has been tested in more than 1,800
individuals and has shown an attractive pharmacokinetic, safety and
tolerability profile. Vidofludimus calcium is not yet licensed or
approved in any country.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing
a clinical pipeline of orally administered, small molecule
therapies for chronic inflammatory and autoimmune diseases. The
company's lead development program, vidofludimus calcium (IMU-838),
is currently in phase 3 and phase 2 clinical trials for the
treatment of relapsing and progressive multiple sclerosis,
respectively, and has shown therapeutic activity in phase 2
clinical trials in patients suffering from relapsing-remitting
multiple sclerosis, progressive multiple sclerosis and
moderate-to-severe ulcerative colitis. Vidofludimus calcium
combines neuroprotective effects, through its mechanism as a
first-in-class nuclear receptor related 1 (Nurr1) activator, with
additional anti-inflammatory and anti-viral effects, by selectively
inhibiting the enzyme dihydroorotate dehydrogenase (DHODH).
IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended
to restore intestinal barrier function and regenerate bowel
epithelium, which could potentially be applicable in numerous
gastrointestinal diseases, such as celiac disease, for which it is
currently in preparations for a phase 2 clinical trial. IMU-381,
which currently is in preclinical testing, is a next generation
molecule being developed to specifically address the needs of
gastrointestinal diseases. 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, sufficiency of cash and cash
runway, expected timing, development and results of clinical
trials, 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
development programs and the targeted diseases; announcements
regarding the positive outcomes of the interim analysis of the
phase 3 ENSURE trials; the potential for vidofludimus calcium to
safely and effectively target diseases; preclinical and clinical
data for vidofludimus calcium; the timing of current and future
clinical trials and anticipated clinical milestones; 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 substantial 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,
increasing inflation, impacts of
the Ukraine – Russia conflict and the conflict
in the Middle East on planned and ongoing clinical
trials, 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 financial and other resources to meet business
objectives and operational requirements, including the ability to
satisfy the minimum average price and trading volume conditions
required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the
results of earlier preclinical studies and clinical 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, 2023, filed with
the SEC on February 22, 2024, 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
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@ksca.com
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SOURCE Immunic, Inc.