Filed by Vital Therapies, Inc.
Pursuant to Rule 425 under the Securities Act of 1933, as amended, and deemed filed
pursuant to Rule
14a-12
under the Securities Exchange Act of 1934, as amended
Subject Company: Vital Therapies, Inc.
Commission File No.:
001-36201
February 26, 2019
Immunic Therapeutics Announces First Patient Enrolled in Phase 2
Clinical Trial of
IMU-838,
an Oral Therapy for Patients with Relapsing-
Remitting Multiple Sclerosis
Planegg-Martinsried, Germany, February 26, 2019
Immunic AG (Immunic), a privately held clinical-stage biotechnology company, today
announced enrollment of the first patient in a phase 2 clinical study of IMU-838 for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
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).
This phase 2 study is an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial that is expected to enroll
approximately 200 patients in more than 40 centers across four European countries. The studys primary objective is to evaluate the dose response of 30 mg/day and 45 mg/day of
IMU-838,
once daily, for the
treatment of RRMS based on magnetic resonance imaging (MRI) assessments. Patients enrolled in the trial will have shown disease activity based on clinical evidence of relapse and MRI criteria.
The trial includes a blinded
24-week
main treatment period with an optional extended treatment period to
evaluate long-term safety and tolerability of
IMU-838
that will be unblinded when all patients have completed the main treatment portion and the study database has been locked. The primary endpoint of the
study is the cumulative number of combined unique active (CUA) MRI lesions, up to week 24.
Daniel Vitt, Ph.D., Chief Executive Officer of Immunic,
stated, Enrollment of the first patient in this trial as planned and on schedule represents another key milestone for Immunic and demonstrates the ability of our company to effectively execute our drug development strategy. We had already
advanced
IMU-838
into a phase 2 trial for ulcerative colitis, so we are excited about its clinical testing in this additional patient population. This development further advances our goal of expanding the
indications for which
IMU-838
shows great promise for patients with chronic inflammatory and autoimmune diseases.
The mode of action of
IMU-838,
DHODH inhibition, is already commercially proven in RRMS, and the safety
and tolerability profiles of
IMU-838
are well understood. To date, more than 350 individuals have been treated with the active moiety, with no general detrimental effect on bone marrow observed in animal
experiments, no increased rate of alopecia or diarrhea, and no increased rate of infections compared with placebo in earlier clinical trials in other indications, commented Andreas Muehler, MD, Chief Medical Officer of Immunic. We look
forward to carrying out this trial in support of further clinical data showing
IMU-838
as a potentially
best-in-class,
once-daily
oral therapy to treat RRMS.
For more information on this clinical trial, please visit:
www.clinicaltrials.gov
, NCT03846219.
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