SAN DIEGO, Sept. 18, 2019 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a
clinical-stage biopharmaceutical company focused on
developing potentially best-in-class, oral therapies for the
treatment of chronic inflammatory and autoimmune diseases, today
announced dosing of the first healthy volunteer in the company's
phase 1 clinical program of IMU-935, a highly potent and selective
inverse agonist of the transcription factor RORγt, believed to be
the main driver for the differentiation of Th17 cells and the
expression of cytokines involved in various inflammatory and
autoimmune diseases. Immunic's Australian subsidiary, Immunic
Australia Pty Ltd., received clearance from the Bellberry Human
Research Ethics Committee in Australia to begin phase 1 trials of IMU-935
under the Clinical Trial Notification (CTN) scheme of the
Australian Therapeutic Goods Administration (TGA). The phase 1
program includes single and multiple ascending dose trials in
healthy volunteers. Immunic also plans to extend these studies to
assess safety and mechanism-related biomarkers in patients with
psoriasis.
The first phase 1 trial is a single ascending dose,
double-blind, placebo-controlled study of IMU-935 in healthy
volunteers. The trial is designed to evaluate the drug's safety and
pharmacokinetic profile and will also include the evaluation of
food effects.
"The dosing of the first healthy volunteer in our phase 1
program of IMU-935 represents an important inflection point for
Immunic, as we progress, on plan, with the development of this
important pipeline candidate," stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "RORγt is a target that has generated a
high degree of interest within the pharmaceutical and biotechnology
communities, given its potential to restore the balance between
pro-inflammatory and regulatory lymphocytes and modulate a range of
cytokines involved in various immune-mediated diseases. The
strength of our own preclinical data leads us to believe that
IMU-935 has best-in-class potential as an oral therapy for a number
of inflammatory and autoimmune diseases."
Following the phase 1 single ascending dose trial, Immunic plans
to initiate a second phase 1 trial which will be a multiple
ascending dose, double-blind, placebo-controlled study in healthy
volunteers with IMU-935 given daily for 14 consecutive days. This
study will assess the safety, pharmacodynamic and pharmacokinetic
properties of IMU-935. The company expects to extend these multiple
ascending dose studies in the first half of 2020 by including
mild-to-moderate psoriasis patients given IMU-935 daily over 28
consecutive days, in order to assess safety and mechanism-related
biomarkers in patients with psoriasis.
Andreas Muehler, M.D., Chief
Medical Officer of Immunic, noted, "We look forward to expanding
the study to psoriasis patients next year, as we believe that
psoriasis provides a prototype disease where the safety and
biomarkers related to the mechanism of action of IMU-935 can be
evaluated within the dosing limitations of an early clinical trial.
Importantly, this may help to guide the planning of a phase 2
program and we expect that it will provide us with preliminary
insights regarding the optimal dosing range which may be safe and
active."
About IMU-935
IMU-935 is a highly potent and
selective inverse agonist of RORγt (retinoic acid receptor-related
orphan nuclear receptor gamma) with additional activity on DHODH
(dihydroorotate dehydrogenase). The nuclear receptor RORγt
is believed to be the main driver for the differentiation of
Th17 cells and the expression of cytokines involved in various
inflammatory and autoimmune diseases. This target is believed to be
an attractive alternative to approved antibodies for targets such
as IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows strong
cytokine inhibition targeting both Th17 and Th1 responses in
preclinical testing, as well as indications of activity in animal
models for psoriasis and inflammatory bowel disease. Preclinical
experiments indicate that, while leading to a potent inhibition of
Th17 differentiation and cytokine secretion, IMU-935 did not affect
thymocyte maturation.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a
clinical-stage biopharmaceutical company developing a pipeline of
selective oral immunology therapies aimed at treating chronic
inflammatory and autoimmune diseases, including relapsing-remitting
multiple sclerosis, ulcerative colitis, Crohn's disease, and
psoriasis. The company is developing three small molecule products:
IMU-838 is a selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme DHODH; IMU-935 is an inverse agonist of RORγt; and IMU-856
targets the restoration of the intestinal barrier function.
Immunic's lead development program, IMU-838, is in phase 2 clinical
development for relapsing-remitting multiple sclerosis and
ulcerative colitis, with an additional phase 2 trial planned in
Crohn's disease. An investigator-sponsored proof-of-concept
clinical trial for IMU-838 in primary sclerosing cholangitis is
ongoing at the Mayo Clinic. For further information, please visit:
www.immunic-therapeutics.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, 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 three development programs and the targeted diseases; the
potential for IMU-838, IMU-935 and IMU-856 to safely and
effectively target diseases; preclinical data for IMU-935; the
timing and implementation of future clinical trials; the nature,
strategy and focus of the company; 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 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, 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
resources to meet business objectives and operational requirements,
the fact that the results of earlier studies and 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 "Item 1A. Risk Factors," in the company's Current Report
on Form 8-K filed on July 17, 2019,
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.immunic-therapeutics.com/sec-filings and on
request from Immunic. 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
Manager IR and Communications
+49 89 250 0794 69
jessica.breu@immunic.de
Or
Rx Communications Group
Melody Carey
+1-917-322-2571
immunic@rxir.com
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SOURCE Immunic, Inc.