SAN DIEGO, Sept. 5, 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 the results of a pre-planned interim
dosing analysis in the phase 2 CALDOSE-1 study of IMU-838 in
patients with moderate-to-severe ulcerative colitis (UC). Based on
the available data, an unblinded and independent data review
committee has concluded that the study's lowest, 10 mg dose was
found not to be likely ineffective and that the highest, 45 mg dose
was not intolerable. As a result, the company intends to continue
the trial with all three dosing arms.
The phase 2 CALDOSE-1 trial is an international, multicenter,
double-blind, placebo-controlled study being conducted in
the United States and Europe and is designed to evaluate the
company's lead compound, IMU-838, in patients with UC. The study's
primary endpoint comprises a composite of a patient reported
outcome and endoscopy-assessed outcome, both to be evaluated
following ten weeks of induction treatment with IMU-838 or
placebo.
Under an agreement between Immunic and the U.S. Food and Drug
Administration (FDA), reached during the company's pre-IND meeting
in 2017, the CALDOSE-1 trial was designed to begin enrollment with
three active dosing arms of 10 mg, 30 mg and 45 mg, respectively,
in addition to a placebo arm. Based on preclinical target
engagement data, Immunic had hypothesized 30 mg to be the
lowest effective dose. The 10 mg dose was added to the trial at the
suggestion of the FDA to include a lower dose than the expected
effective doses. The interim dosing analysis was to be conducted
after approximately 60 patients were evaluable following their
ten-week induction treatment. At the time, Immunic anticipated that
the lowest, 10 mg dose might be found to be likely ineffective in
this interim dosing analysis, and therefore discontinued.
The interim dosing analysis has now been performed by an
unblinded and independent data review committee, which has
concluded that the 10 mg dose appeared not to be likely
ineffective, the 45 mg dose was not intolerable, and no safety
signal was identified for any of the trial's three doses of
IMU-838. The data review committee has not shared with the company
any of the unblinded data underlying these conclusions, and the
study remains blinded to the company, the investigators and the
enrolled patients. The interim dosing analysis was not designed to
be a futility analysis nor was the primary endpoint or any other
endpoint of the study tested statistically.
As a result of these findings, the trial's steering committee
has recommended continuation of all three dosing arms, which
recommendation is intended to be implemented by Immunic. Expansion
of IMU-838's potentially effective dose range will require
inclusion of a third active dosing arm to the study's second
enrollment period and will increase the overall number of patients
expected to be included in the ongoing trial from a previously
anticipated 195 patients, to a total of approximately 240
anticipated patients.
"While unexpected, we are very pleased to learn that even the
lowest, 10 mg dose seems to show activity, suggesting that the
potentially effective dose range for UC patients may be broader
than previously thought," stated Daniel
Vitt, Ph.D., Chief Executive Officer and President of
Immunic. "Moreover, the knowledge that all three doses included in
the CALDOSE-1 trial did not show unacceptable intolerance and are
expected to be continued confirms the promising safety profile
already established for IMU-838 in previous studies. These results
speak to the strength of IMU-838 as a possible best-in-class oral
therapy for this growing patient population. We look forward to
continuing the study and reporting top-line data, when
available."
Management noted that the positive findings of this interim
dosing analysis will impact the timing of completion of patient
enrollment, previously expected during the second half of 2020, as
well as availability of top-line data, which was anticipated during
the first quarter of 2021. Management will re-evaluate and report
on its adjusted timeline with respect to the CALDOSE-1 study, as
well as the expected dose selection and initiation of the CALDOSE-2
phase 2 trial of IMU-838 in Crohn's disease patients, after a
thorough review has been completed.
Finally and as pre-defined in the study protocol,
this interim dosing analysis was based on data from only a
relatively small number of patients in the CALDOSE-1
trial, and no formal statistical analysis was performed. This
interim dosing analysis and the conclusions made by the
independent data review committee may not reflect results of a
final analysis of the trial once the full data
set is analyzed.
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 direct
antiviral effect. 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. Immunic also intends to initiate an additional
phase 2 trial in patients with Crohn's disease. Furthermore,
Immunic's collaboration partner, Mayo Clinic, has started an
investigator-sponsored proof-of-concept clinical trial testing
IMU-838 activity in patients with primary sclerosing
cholangitis.
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 RORĪ³t; 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 and clinical data for
IMU-838; the timing of future clinical trials and expected results
of such 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.