– Unblinded Interim Biomarker
Analysis Expected in the Fall of 2023 –
– Full Data Readout Expected in
April 2025 –
NEW
YORK, Aug. 17, 2023 /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
the completion of enrollment of its phase 2 CALLIPER trial of lead
asset, vidofludimus calcium (IMU-838), in patients with progressive
multiple sclerosis (PMS). In total, 467 patients with primary
PMS, or active or non-active secondary PMS have been randomized to
either 45mg of vidofludimus calcium or placebo. The trial, running
concurrently and as a complement to the company's twin phase 3
ENSURE trials in relapsing multiple sclerosis (RMS), is focused on
progressive forms of multiple sclerosis (MS) and is designed to
corroborate vidofludimus calcium's neuroprotective potential in
this patient population.
Anticipated Milestones for the CALLIPER Trial:
- An interim analysis comprising unblinded biomarker data,
including serum neurofilament light chain (NfL), is expected to be
available in the fall of 2023 and will include data for
approximately half of the enrolled patients (225) who have
completed a follow-up period of at least 24 weeks of study
treatment.
- A top-line data readout of the full 467 patients is now
expected in April of 2025.
"Our phase 2 CALLIPER trial is designed to corroborate the
neuroprotective potential of vidofludimus calcium in a progressive
patient population. Enrollment of the final PMS patient, according
to plan, is another important milestone in the clinical development
of our lead asset in MS," stated Daniel
Vitt, Ph.D., Chief Executive Officer and President of
Immunic. "We believe that the data from the CALLIPER trial, along
with that from our ENSURE program, in conjunction with vidofludimus
calcium's postulated neuroprotective effects as a first-in-class
nuclear receptor related 1 (Nurr1) activator as well as its strong
safety and tolerability profile shown, to date, may further
strengthen the uniqueness of this treatment approach compared to
other oral MS medications and result in a highly attractive
commercial positioning."
"As reported in May of this year, in preclinical testing, we
have discovered strong Nurr1 agonism by vidofludimus calcium. The
known characteristics of Nurr1 activation suggest broad therapeutic
potential in neurodegenerative pathologies including MS," added
Andreas Muehler, M.D., Chief Medical
Officer of Immunic. "The neuroprotective properties of vidofludimus
calcium were already identified in our phase 2 EMPhASIS trial of
vidofludimus calcium in relapsing-remitting MS, by showing an
initial signal for prevention of confirmed disability worsening, as
reported in November of last year. We look forward to reporting the
interim analysis of our CALLIPER trial, expected in the fall of
this year, to assess biomarkers that have been shown in third-party
research to consistently correlate with disease activity in
neurodegenerative disorders."
CALLIPER is an international, multicenter, randomized,
double-blind, placebo-controlled phase 2 trial which enrolled 467
patients at more than 70 sites throughout North America as well as Western, Central and
Eastern Europe, with patients
randomized to either 45 mg daily doses of vidofludimus calcium 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).
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 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 known 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 1,400
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 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, where 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, 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; 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 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, 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,
2022, filed with the SEC on February
23, 2023, 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
+1 917 633 7790
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com
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SOURCE Immunic, Inc.