– Top-Line Data from Phase 2
CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple
Sclerosis Expected in April –
– Reported Positive Outcome from Interim
Analysis of Ongoing, Twin Phase 3 ENSURE Trials of Vidofludimus
Calcium in Relapsing Multiple Sclerosis; Both Trials on Track to Be
Completed in 2026 –
– Strengthened Management Team and Board of
Directors with Key Hires –
– Announced a Three-Tranche Private Placement
Totaling Up to $240 Million,
Extending Cash Runway Into the Third Quarter of 2025, Based on
Initial $80 Million Tranche –
NEW
YORK, Jan. 7, 2025 /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 highlighted its 2024 accomplishments and
upcoming milestones.
"The past year was marked by substantial progress for our orally
available lead asset, nuclear receptor related 1 (Nurr1) activator,
vidofludimus calcium (IMU-838), as we continued to advance both our
phase 2 CALLIPER trial in patients with progressive multiple
sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing
multiple sclerosis (RMS)," stated Daniel
Vitt, Ph.D., Chief Executive Officer of Immunic. "Looking
ahead, we eagerly anticipate reporting top-line data from the
CALLIPER trial in April. The previously reported interim results
showed a clear reduction versus placebo in neurofilament light
chain (NfL) levels across the PMS patient population, hinting to
potential neuroprotective effects of the drug."
"We also achieved a significant milestone for our phase 3 ENSURE
program, having received a positive interim result from an
unblinded Independent Data Monitoring Committee (IDMC), which
concluded that the trials are not futile and recommended they
should continue as planned, without any sample size increase. These
favorable recommendations corroborated our initial assumptions
about the design, powering and relapse rate of the trials and
illustrate that they remain on track. The result makes us immensely
confident and excited as we await the completion of the twin phase
3 trials: ENSURE-1 remains on track for completion in the second
quarter of 2026, with ENSURE-2 expected to follow in the second
half of 2026."
Jason Tardio, President and Chief
Operating Officer of Immunic, added, "Since joining Immunic in
July 2024, we have ramped up our
efforts preparing for the potential commercial launch of
vidofludimus calcium. There continues to be a large unmet medical
need for new therapeutic advancements in the treatment of MS that
address both the neuroinflammatory and neurodegenerative aspects of
the disease to better slow disability worsening. Vidofludimus
calcium is the only medicine in development that targets activation
of Nurr1 for neuroprotection and combines that with selective
inhibition of DHODH for anti-inflammatory and antiviral effects. We
believe our drug has the potential to become the first oral
disease-modifying therapy approved to treat both relapsing and
progressive MS to address the full spectrum of the disease."
Dr. Vitt concluded, "In 2024, we were also honored to have had
our previously reported results from the phase 1/1b clinical trial of IMU-856, our orally
available and systemically acting small molecule modulator
targeting Sirtuin 6 (SIRT6), a protein which serves as a
transcriptional regulator of intestinal barrier function and
physiological regeneration of bowel epithelium, published in the
peer reviewed journal, The Lancet Gastroenterology &
Hepatology. Data from this study showed that, in patients with
celiac disease during periods of gluten-free diet and gluten
challenge, IMU-856 demonstrated positive effects over placebo in
four key dimensions of celiac disease, including protection of the
gut architecture, improvement of patients' symptoms, biomarker
response, and enhancement of nutrient absorption. We continue to
believe that IMU-856 could offer a new therapeutic approach for
various gastrointestinal disorders, also beyond celiac
disease."
2024 Corporate Highlights
- Strengthened the Board of Directors in July, with the
appointment of Simona Skerjanec, M.Pharm, MBA, a
thought-leader in brain health with decades of experience.
- In July, appointed seasoned biopharmaceutical executive,
Jason Tardio, as President and Chief
Operating Officer, to lead internal efforts in positioning the
company for the potential launch of vidofludimus calcium and to
work closely with Patrick Walsh,
Chief Business Officer, to prepare the company for a range of
potential partnership outcomes. Additionally, reported that Werner
Gladdines, former Vice President, Program Management & Clinical
Development Operations, was promoted to Chief Development
Officer.
- Announced a three-tranche private placement totaling up to
$240 million, with participation from
select new and existing investors, in January. The initial tranche
successfully closed on January 8,
2024, with Immunic securing $80
million in gross proceeds.
Vidofludimus Calcium 2024 Highlights and Upcoming
Milestones
- Completion of the ENSURE-1 trial of vidofludimus calcium in RMS
is anticipated in the second quarter of 2026, with completion of
ENSURE-2 expected in the second half of 2026.
- Top-line data for the phase 2 CALLIPER trial of vidofludimus
calcium in PMS is expected in April of this year.
- Announced a positive outcome of the interim analysis of the
phase 3 ENSURE program, investigating vidofludimus calcium for the
treatment of RMS, in October. An unblinded IDMC confirmed that
the trials are not futile and recommended they should continue
without changes, including no need for a potential increase of the
sample size.
- Presented key data on vidofludimus calcium in four
presentations at the 40th Congress of the European
Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) in September. The data included the NfL interim data from
the phase 2 CALLIPER trial, antiviral data suggesting an effect on
reducing fatigue, Nurr1 target data supporting a neuroprotective
profile, and pathogenic T cell data further supporting the drug's
anti-inflammatory effects.
- Announced enrollment of the first patient in the
investigator-sponsored phase 2 RAPID_REVIVE trial of
vidofludimus calcium in patients with post COVID syndrome in
September.
- Hosted an MS R&D Day in New York
City in September, focused on vidofludimus calcium's
potential to become the treatment of choice for both RMS and PMS
patients. Presenting MS industry experts included Francesca
Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi
(NICO) and University of Turin,
Italy and Amit Bar-Or, M.D., FRCPC, Department of Neurology,
Perelman School of Medicine, University of
Pennsylvania.
- Published extended data from the phase 2 EMPhASIS trial of
vidofludimus calcium in relapsing-remitting MS in the peer reviewed
journal, Neurology® Neuroimmunology &
Neuroinflammation, an official journal of the American Academy
of Neurology, in April.
- Hosted an MS R&D Day in San
Francisco in April, during which management discussed the
latest developments in the MS landscape, along with recent
preclinical and clinical data supporting the neuroprotective
potential of vidofludimus calcium.
- Received a Notice of Allowance from the United States Patent
and Trademark Office (USPTO) in March, for a patent covering the
composition-of-matter of a specific polymorph of vidofludimus
calcium and a related method of production of the material. The
company's multilayered intellectual property strategy now provides
protection into 2041 in the United
States, unless extended further.
- Presented data from the company's phase 2 CALLIPER and CALVID-1
trials of vidofludimus calcium, in two poster presentations at the
Americas Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS) Forum 2024 in February.
IMU-856 2024 Highlights and Upcoming Milestones
- Announced the publication of data from the phase 1/1b clinical trial of IMU-856 in the peer reviewed
journal, The Lancet Gastroenterology & Hepatology
in November.
- Based on the positive data from the phase 1b clinical trial, the company continues
preparing for clinical phase 2 testing of IMU-856, contingent on
financing, licensing or partnering.
Immunic's management, business development and investor
relations teams will be hosting one-on-one meetings in connection
with the 43rd Annual J.P. Morgan Healthcare Conference taking place
January 13-16, 2025, in San Francisco. To schedule a meeting, please
contact: Jessica Breu at
jessica.breu@imux.com.
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; the potential for
Immunic's development programs to safely and effectively target
diseases; preclinical and clinical data for Immunic's development
programs; 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; the
development and commercial potential of any product candidates of
the company; expectations regarding the capitalization, resources
and ownership structure of the company; the executive and board
structure of the company; and the company's expected cash runway.
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 of 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@kcsa.com
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SOURCE Immunic, Inc.