– Includes Phase 1 Data in Healthy
Human Subjects and Phase 1b Data in
Celiac Disease Patients –
NEW
YORK, Nov. 13, 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 that the data from its phase
1/1b clinical trial of IMU-856, an
orally available and systemically acting small molecule modulator
that targets SIRT6 (Sirtuin 6), has been published in the peer
reviewed journal, The Lancet Gastroenterology &
Hepatology. Lead authored by Dr. A. James Daveson,
Gastroenterologist, Wesley Research Institute and Coral Sea
Clinical Research Institute, Queensland,
Australia, the paper is entitled, "Safety, clinical
activity, pharmacodynamics, and pharmacokinetics of IMU-856, a
SIRT6 modulator, in coeliac disease: a first-in-human, randomised,
double-blind, placebo-controlled, phase 1 trial." It can be
accessed through the following link:
https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00248-6/fulltext.
Dr. Daveson stated, "Celiac disease affects approximately 1.4%
of the world's population. The only current treatment option is a
strict, lifelong gluten-free diet, which poses significant
challenges due to dietary and social restrictions and the risk of
cross-contamination, which leads to persistent intestinal
inflammation with villous atrophy in many patients. IMU-856's
potential ability to improve the integrity and function of the
intestinal barrier represents a promising, novel approach to treat
this condition. Importantly, this phase 1b clinical trial is the first study to show that
IMU-856 can mitigate the gluten-related effects in celiac disease
patients. Based on this result, in conjunction with the drug's
favorable safety and tolerability profile, we have concluded that
it warrants further clinical investigation."
"The publication of our phase 1/1b
clinical data in healthy human subjects and patients with celiac
disease, in such a prestigious peer reviewed journal, confirms that
IMU-856's novel mechanism modulating SIRT6, a protein which serves
as a transcriptional regulator of intestinal barrier function and
physiological regeneration of bowel epithelium, can represent an
entirely new approach to treating gastrointestinal diseases," added
Daniel Vitt, Ph.D., Chief Executive
Officer of Immunic. "In our phase 1b
clinical trial, IMU-856 showed the first clinical signals of its
potential ability to restore a healthy gut by renewal of the gut
wall, demonstrating meaningful improvements over placebo in four
key dimensions of celiac disease pathophysiology: histology,
disease symptoms, biomarkers and nutrient absorption. Together with
a favorable safety and tolerability profile, it may set the stage
for a potential first-in-class, oral celiac disease therapy.
Additionally, we believe that this data provides initial clinical
proof-of-concept for a potentially new, oral therapeutic approach
to a range of gastrointestinal diseases with high unmet needs,
beyond celiac disease."
The first two portions of the phase 1 clinical trial, Parts A
and B, were single ascending dose and multiple ascending dose,
double-blind, placebo-controlled studies in a total of 71 healthy
human subjects. Single and multiple ascending doses of IMU-856 were
found to be safe and well-tolerated, with no investigational
medicinal product (IMP)-related serious or severe
treatment-emergent adverse events. No maximum tolerated dose was
reached in either part.
Part C was structured as a double-blind, randomized,
placebo-controlled trial, designed to assess the safety and
tolerability of IMU-856 in patients with celiac disease during
periods of gluten-free diet and a 15-day gluten challenge with 6 g
of gluten given daily. Further objectives included pharmacokinetics
and initial clinical activity assessments, including malabsorption
parameters, biomarkers for enterocyte functional mass, such as
citrulline, disease-related symptoms as well as histological
changes. The trial was conducted at sites in Australia and New
Zealand. A total of 43 patients were enrolled in two
consecutive cohorts with 80 mg or 160 mg of IMU-856 or placebo
given once-daily over 28 days. 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. There were no IMP-related
serious or severe treatment-emergent adverse events, nor was there
any dose-dependency in adverse events. Moreover, the rates of
treatment-emergent adverse events in non-disease-related parameters
were comparable between the active treatment groups and
placebo.
About IMU-856
IMU-856 is an orally available and
systemically acting small molecule modulator that targets SIRT6
(Sirtuin 6), a protein which serves as a transcriptional regulator
of intestinal barrier function and regeneration of bowel
epithelium. Based on preclinical data, the compound may represent a
unique treatment approach, as the mechanism of action targets the
restoration of the intestinal barrier function and bowel wall
architecture in patients suffering from gastrointestinal diseases
such as celiac disease, inflammatory bowel disease and other
intestinal barrier function associated diseases. Based on
preclinical investigations demonstrating no suppression of immune
cells, IMU-856 may have the potential to maintain immune
surveillance for patients during therapy, which would be an
important advantage versus immunosuppressive medications. IMU-856
demonstrated positive results in a phase 1b clinical trial in celiac disease patients in
four key dimensions of the disease's pathophysiology: histology,
disease symptoms, biomarkers and nutrient absorption. Currently,
the company is preparing for phase 2 clinical testing. IMU-856 is
an investigational drug product that has not been approved in any
jurisdiction.
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
IMU-856 to safely and effectively target diseases; preclinical and
clinical data for IMU-856; 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@kcsa.com
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SOURCE Immunic, Inc.