NEW YORK, May 13, 2020 /PRNewswire/ -- Immunic, Inc.
(Nasdaq: IMUX), a clinical-stage biopharmaceutical company
focused on developing best-in-class, oral therapies for the
treatment of chronic inflammatory and autoimmune diseases, today
announced that it has received first regulatory approval from
Germany's BfArM (Bundesinstitut
für Arzneimittel und Medizinprodukte) to initiate a phase 2
clinical trial of its selective oral DHODH inhibitor, IMU-838, in
coronavirus disease 2019 (COVID-19). The CALVID-1 study is a
prospective, multicenter, randomized, placebo-controlled,
double-blind phase 2 clinical trial in approximately 230 patients
with moderate COVID-19, designed to evaluate efficacy, safety and
tolerability of IMU-838. Dosing of the first patient is expected to
occur later this month. Top-line data is expected to be available
later this year.
"Approval to begin the CALVID-1 phase 2 clinical trial in
Germany is a significant
achievement that will allow for the near-term investigation of the
oral DHODH inhibitor, IMU-838, in COVID-19 patients," commented
Prof. Maria Vehreschild, M.D., Head of Infectious Diseases at
University Hospital Frankfurt and Principal Investigator of one of
the clinical sites participating in the study. "Given IMU-838's
broad antiviral effect, recently confirmed preclinical activity
against SARS-CoV-2 itself, as well as its selective effect against
hyper-activated immune cell populations which may play a role in
the potentially deadly complications of interstitial lung disease,
IMU-838 represents a prospective, potential treatment option that
merits urgent investigation."
Immunic recently announced that IMU-838 had successfully
demonstrated preclinical activity against severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2). Specifically, IMU-838 was
observed to inhibit replication of clinical isolates of SARS-CoV-2
associated with COVID-19. In cellular assays, IMU-838 demonstrated
this antiviral activity at concentrations which are well below the
blood concentrations associated with IMU-838 dosing regimens
studied in ongoing and previous clinical trials. In addition,
IMU-838 has an attractive pharmacokinetic, safety and tolerability
profile and, to date, has already been tested in about 650
individuals.
The aim of the CALVID-1 trial is to investigate IMU-838 as an
oral treatment option for COVID-19 and to enable the use of IMU-838
as a treatment for current and potential future pandemic threats.
The trial is expected to initially enroll approximately 230
patients at 10-35 centers across Europe and the
United States. Patients will be randomized to receive either
22.5 mg of IMU-838 twice daily, or placebo twice daily, for 14
consecutive days. All patients are also eligible to receive
investigator's choice of standard-of-care therapy throughout the
duration of the study. Inclusion criteria are hospitalized adult
patients with a confirmed SARS-CoV-2 infection fulfilling clinical
status category 3 or 4, as assessed with the nine-category ordinal
scale proposed by the World Health Organization (WHO) COVID-19
Therapeutic Trial Synopsis, as well as certain additional clinical
and laboratory conditions. The primary endpoint will be the
proportion of patients free of invasive ventilation throughout the
entire study period. Secondary endpoints include duration of
hospitalization, duration of intensive care unit (ICU)
treatment, 28-day all-cause mortality, time to clinical improvement
and viral titer reduction.
The CALVID-1 study will employ an adaptive trial strategy by
including interim safety and efficacy assessments. If clinical
activity of IMU-838 is confirmed by the Independent Data Monitoring
Committee after the first interim analysis, which is scheduled to
occur after approximately 200 patients have completed the blinded
treatment period, an expansion of this trial into a confirmatory
phase 3 trial could be recommended.
"The speed of preparation and approval for this important phase
2 clinical trial for IMU-838 speaks to the strength of our data
package, while also reflecting the urgent global need to develop
useful therapies against COVID-19," stated Andreas Muehler, M.D., Chief Medical Officer of
Immunic. "IMU-838's profile, as an orally available DHODH inhibitor
that employs a host-based mode of action, thereby providing
broad-spectrum antiviral activity, makes it a unique, potential
therapeutic option which may be applicable as either a standalone
or combination therapy. All phase 2 preparatory activities have
been completed and we anticipate beginning the trial in short
order."
For more information on this clinical trial, please visit:
www.clinicaltrials.gov, NCT04379271.
About IMU-838
IMU-838 is an orally available,
next-generation selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on
activated T and B cells while leaving other immune cells largely
unaffected and allows the immune system to stay functioning, e.g.
in fighting infections. In previous trials, IMU-838 did not show an
increased rate of infections compared to placebo. In addition,
DHODH inhibitors, such as IMU-838, are known to possess a
host-based antiviral effect, which is independent with respect to
specific virus proteins and their structure. Therefore, DHODH
inhibition may be broadly applicable against multiple viruses.
IMU-838 was successfully tested in two phase 1 clinical trials in
2017 and is currently being tested in phase 2 trials in patients
with relapsing-remitting multiple sclerosis and ulcerative colitis.
IMU-838 is also under investigation as a potential treatment option
for SARS-CoV-2 infections associated with COVID-19. Furthermore,
Immunic's collaboration partner, the Mayo Clinic, has started an
investigator-sponsored proof-of-concept clinical trial testing
IMU-838 activity in patients with primary sclerosing cholangitis.
To date, IMU-838 has already been tested in about 650 individuals
and has shown an attractive pharmacokinetic, safety and
tolerability profile.
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 considered in
Crohn's disease. The company is also investigating IMU-838 as a
potential treatment option for COVID-19. 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.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, 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 to safely and effectively target diseases;
preclinical and clinical data for IMU-838; the timing of current
and future clinical trials; the potential for IMU-838 as a
treatment for severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infections associated with coronavirus disease 2019
(COVID-19) and any clinical trials, collaborations and approvals
relating to such potential treatment; 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, the
COVID-19 pandemic, 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 "Risk Factors," in the company's
Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC on
March 16, 2020, the company's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on
May 8, 2020, 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 Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Melody Carey
+1-917-322-2571
immunic@rxir.com
US Media Contact
Knight Marketing Communications,
Ltd.
Kevin Knight
+1-206-451-4823
kknightpr@gmail.com
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