– Evidence for Neuroprotective Activity of
Vidofludimus Calcium from Phase 2 CALLIPER Interim
Analysis, Consistent Across the Entire Progressive
Multiple Sclerosis Population and All Subtypes –
– Phase 3 ENSURE Program in Relapsing Multiple
Sclerosis Ongoing –
– Improvements in Gut Health Demonstrated in
Phase 1b Clinical Trial of IMU-856 in
Celiac Disease –
– Expanded Vidofludimus Calcium Patent
Portfolio with Additional New Patents Granted;
Exclusivity Protection Expected Into 2041 in the United States, Unless Extended
Further –
– Significantly Strengthened Balance Sheet;
Cash Runway Extended Into the Third Quarter of 2025 Based on First
Tranch of January 2024 Financing
–
NEW
YORK, Jan. 5,
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 highlighted its 2023
accomplishments and upcoming milestones.
"The past year has been an extra-ordinarily productive and
successful one for Immunic, with key clinical data releases
highlighting the uniqueness and enormous value potential of each of
our two latest-stage clinical assets," stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "With vidofludimus calcium (IMU-838) and
IMU-856, we have two development programs beyond clinical
proof-of-concept which is an outstanding achievement of our entire
team. Regarding our lead asset, nuclear receptor related 1 (Nurr1)
activator, vidofludimus calcium, the interim biomarker analysis
from the phase 2 CALLIPER trial demonstrated clear separation from
placebo in serum neurofilament light chain (NfL) levels in patients
with progressive multiple sclerosis (PMS). This effect was observed
across all subpopulations, including non-active secondary
progressive multiple sclerosis, which we believe represents the
segment of greatest unmet need in multiple sclerosis (MS). We look
forward to continuing development of this potentially
groundbreaking asset. Enrollment in CALLIPER is complete, with
top-line data expected in April 2025.
Meanwhile, enrollment in our phase 3 ENSURE program remains active,
with an interim futility analysis expected in late 2024 and the
read-out of the first of the ENSURE trials anticipated in the
second quarter of 2026."
Dr. Vitt continued, "Regarding IMU-856, our orally available and
systemically acting small molecule modulator targeting Sirtuin 6
(SIRT6), results from our phase 1b trial demonstrated meaningful improvements
over placebo in four key dimensions of celiac disease
pathophysiology: histology, disease symptoms, biomarkers and
nutrient absorption. We believe this data provides initial clinical
proof-of-concept for a potentially new therapeutic approach to a
multitude of gastrointestinal disorders through the regeneration of
bowel architecture rather than the traditional immunomodulatory
approaches in many gastrointestinal indications. We are currently
preparing for phase 2 testing in ongoing active celiac disease
(OACD), with further clinical applications in other
gastrointestinal disorders also being considered."
"On a scientific level, we announced preclinical evidence
showing that vidofludimus calcium acts as a potent Nurr1 activator,
which may be associated with both its hypothesized neuroprotective
effects and the reduced disability-worsening events observed in our
phase 2 EMPhASIS trial in relapsing-remitting MS patients. We have
also continued to strengthen our patent portfolio for vidofludimus
and its salt and free acid forms, with additional new layers of
patents granted, now providing protection into 2041 in the United States and into 2038
internationally. We expect to continue to expand the patent
protection around vidofludimus calcium in the future," Dr. Vitt
continued.
"Financially, we announced a three-tranche private placement of
up to $240 million earlier today. We
expect the first $80 million tranche
to extend our cash runway into the third quarter of 2025, which
well covers the top-line data readout of our CALLIPER trial in
Aprill 2025. The second tranche, assuming it is excersied, would
even finance us into the first quarter of 2027. Despite challenging
capital markets, we are proud to see enormous support from new and
existing investors, including lead investor BVF Partners, as well
as Avidity Partners, Janus Henderson Investors, Soleus Capital, RTW
Investments and Adage Capital Partners. Finally, I want to share my
pride in our broader team, who were honored to win multiple,
prestigious international awards in 2023 recognizing Immunic's
excellence in a number of clinical, corporate and communications
categories. I am very excited to see what our team can achieve in
2024 and beyond," concluded Dr. Vitt.
A more thorough review of recent events and upcoming milestones
follows:
Corporate Highlights
- Announced a three-tranche private placement of up to
$240 million with participation from
select new and existing investors today.
- Strengthened Board of Directors in April
2023 with the addition of Richard
Rudick, M.D., a thought-leader in MS with decades of
experience in the clinic, academia and industry.
Vidofludimus Calcium 2023 Highlights and Upcoming
Milestones
- Reported positive interim data from the phase 2 CALLIPER trial
of vidofludimus calcium in PMS in October. Serum NfL improvements
were consistently observed for vidofludimus calcium across PMS and
all disease subtypes, as well as in patients who showed or did not
show disease and/or magnetic resonance imaging (MRI) activity.
Immunic believes that this data illustrates biomarker evidence that
vidofludimus calcium's activity extends beyond the previously
observed anti-inflammatory effects, further reinforcing its
neuroprotective potential. Enrollment of the trial was completed in
August. In total, 467 patients with primary PMS, or active or
non-active secondary PMS, were randomized to either 45 mg of
vidofludimus calcium or placebo.
- Published preclinical data in the peer-reviewed, high impact,
Journal of Medicinal Chemistry in May, confirming that vidofludimus
calcium acts as a potent Nurr1 activator, in addition to its known
mode of action as a dihydroorotate dehydrogenase (DHODH) inhibitor.
Data showed that activation of Nurr1 could be responsible for the
drug's postulated neuroprotective effects and may contribute to the
previously reported reduction of confirmed disability worsening
events seen in the phase 2 EMPhASIS trial in relapsing-remitting MS
patients.
- Reported positive data from the maintenance phase of the phase
2b CALDOSE-1 trial of vidofludimus
calcium in patients with moderate-to-severe ulcerative colitis in
April.
- Significantly strengthened the multiple layers of patent
protection around vidofludimus calcium, and other salt and free
acid forms, with the receipt of two Notices of Allowance from the
USPTO, covering the dosing regimens in MS and the dose strength for
the treatment of RMS. The current patent portfolio provides
protection into 2041 in the United
States and into 2038 internationally, unless extended
further.
- Top-line data from the phase 2 CALLIPER trial of vidofludimus
calcium in PMS is expected in April
2025.
- An interim futility analysis of the ENSURE program is expected
in late 2024. The read-out of the first of the ENSURE trials is
currently anticipated in the second quarter of 2026; and the second
ENSURE trial in the second half of 2026.
IMU-856 2023 Highlights and Upcoming Milestones
- Announced, for the first time, IMU-856's molecular mode of
action as a highly selective and potent small molecule modulator of
SIRT6, a protein which serves as a transcriptional regulator of
intestinal barrier function and regeneration of bowel epithelium,
in May.
- Announced positive results from the part C portion of the phase
1 clinical trial of IMU-856 in patients with celiac disease in May.
The data demonstrated positive effects for IMU-856 over placebo in
four key dimensions of celiac disease pathophysiology: protection
of the gut architecture, improvement of patients' symptoms,
biomarker response and enhancement of nutrient absorption. IMU-856
was also observed to be safe and well-tolerated in this trial.
Immunic believes this data provides initial clinical
proof-of-concept for an entirely new therapeutic approach to
gastrointestinal disorders by promoting regeneration of bowel
architecture.
- The company is preparing for clinical phase 2 testing of
IMU-856 in OACD patients.
Award Recognition
- MS R&D webcast held in November 2022:
- Gold German Stevie Awards for 'Best Medical Event' and
'Best B2B Event'
- American Business Gold Awards in the 'Conferences &
Meetings – Medical Congress' and 'Conferences & Meetings –
Scientific Congress' categories and Bronze Award in the 'Corporate
& Community – B2B Event' category
- International Business Gold Award in the 'Conferences &
Meetings - Medical Congress' category
- Newly designed, accessibility-friendly website:
- Gold German Stevie Award for 'Best Overall Design' and
Bronze Stevie Award for 'Special Achievement in Diversity &
Inclusion'
- American Business Silver Award in the 'Achievement in Diversity
& Inclusion' category
- BioTech Breakthrough Award winner for the 'Developmental
Immunology Solution of the Year' for the IMU-856 development
program, including the positive phase 1b clinical trial results in celiac disease
- Hella Kohlhof, Ph.D.,
Chief Scientific Officer of Immunic, was awarded a Silver Stevie
Award for Women in Business in the 'Women in Healthcare'
category
Immunic's management, business development and investor
relations teams will be hosting one-on-one meetings in connection
with the 42nd Annual J.P. Morgan Health Care Conference taking
place January 8-11, 2024 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 expected future
events, including the private placement and expected proceeds,
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 ability to raise
additional capital, if needed; 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; 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, 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.