MediciNova Announces Plans to Move Forward with a Phase 3 Trial of MN-166 (ibudilast) in ALS
April 15 2019 - 7:00PM
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ
Global Market (Nasdaq: MNOV) and the JASDAQ Market of the Tokyo
Stock Exchange (Code Number: 4875), today announced that the U.S.
Food and Drug Administration (FDA) has completed its review of the
protocol and determined that MediciNova may proceed with a Phase
2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral
sclerosis (ALS). If this potentially pivotal trial is successful,
the Phase 2b/3 efficacy and safety data is intended to support a
New Drug Application (NDA) for MN-166 (ibudilast) in ALS. The trial
will be fully funded by MediciNova.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc., commented, "We are very pleased to have
successfully completed the FDA review period and look forward to
initiating patient enrollment shortly. The efficacy and safety data
from this trial will potentially support an NDA and may lead to FDA
approval of MN-166 for ALS. While we acknowledge this was an
important milestone, and we have a clear path forward, this moment
is of great importance to the ALS community. We give them our
sincerest appreciation for their patience and optimism." Dr. Iwaki
further commented, "Patients will be eligible to receive study drug
from MediciNova after completing the required treatment period in
this trial."
About the ALS Trial
Based on review and discussion of the Phase 1b/2a trial results
with FDA, the design of the Phase 2b/3 clinical trial includes the
following elements:
- Multi-center, two-arm, randomized, double-blind,
placebo-controlled trial to evaluate MN-166 (ibudilast) vs. placebo
in approximately 150 ALS patients in the U.S.;
- Patients will be randomized 1:1 to receive either 100 mg/day
MN-166 (ibudilast) or placebo for 9 months;
- The primary endpoint is the mean change in functional activity
at Month 9 as measured by the ALSFRS-R score (Amyotrophic Lateral
Sclerosis Functional Rating Scale-revised), which is an approvable
endpoint and is a widely accepted tool to measure the functional
status of ALS patients;
- Secondary endpoints include mean change from baseline of muscle
strength and quality of life, the utilization of and time to
clinically indicated prescription for non-invasive ventilation,
safety and tolerability.
Major inclusion criteria for trial eligibility will include ALS
onset no more than 18 months before screening, at least one
documented ALSFRS-R score between 3 and 6 months before screening,
use of riluzole for at least 30 days before initiation of study
drug, and total ALSFRS-R score of at least 35 at screening.
Patients taking Radicava (edaravone) or Nuedexta
(dextromethorphan/quinidine) may qualify for enrollment if these
treatments are suspended 3 months prior to signing consent.
About ALS
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's
disease, is a progressive neurodegenerative disease that affects
nerve cells in the brain and the spinal cord. The nerves lose the
ability to trigger specific muscles, which causes the muscles to
become weak. As a result, ALS affects voluntary movement, and
patients in the later stages of the disease may become completely
paralyzed. Life expectancy of an ALS patient is usually 2-5 years.
According to the ALS Association, there are approximately 20,000
ALS patients in the U.S. and approximately 6,000 people in the U.S.
are diagnosed with ALS each year.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a first-in-class, orally bioavailable,
small molecule macrophage migration inhibitory factor (MIF)
inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that
suppresses pro-inflammatory cytokines and promotes neurotrophic
factors. It attenuates activated glial cells, which play a major
role in certain neurological conditions. MN-166 (ibudilast)'s
anti-neuroinflammatory and neuroprotective actions have been
demonstrated in preclinical and clinical studies, which provide the
rationale for treatment of amyotrophic lateral sclerosis (ALS),
progressive multiple sclerosis (MS) and other neurological diseases
such as glioblastoma (GBM), and substance abuse/addiction.
MediciNova is developing MN-166 for ALS, progressive MS and other
neurological conditions such as glioblastoma, substance
abuse/addiction, and chemotherapy-induced neuropathy. MediciNova
has a portfolio of patents which covers the use of MN-166
(ibudilast) to treat various diseases including ALS, progressive
MS, and drug addiction.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company
founded upon developing novel, small-molecule therapeutics for the
treatment of diseases with unmet medical needs with a primary
commercial focus on the U.S. market. MediciNova's current strategy
is to focus on MN-166 (ibudilast) for neurological disorders such
as progressive multiple sclerosis (MS), amyotrophic lateral
sclerosis (ALS), substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence) and glioblastoma
(GBM), and MN-001 (tipelukast) for fibrotic diseases such as
nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary
fibrosis (IPF). MediciNova’s pipeline also includes MN-221
(bedoradrine) and MN-029 (denibulin). For more information on
MediciNova, Inc., please visit www.medicinova.com.
Statements in this press release that are not historical in
nature constitute forward-looking statements within the meaning of
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements include,
without limitation, statements regarding the future development and
efficacy of MN-166, MN-001, MN-221, and MN-029. These
forward-looking statements may be preceded by, followed by or
otherwise include the words "believes," "expects," "anticipates,"
"intends," "estimates," "projects," "can," "could," "may," "will,"
"would," “considering,” “planning” or similar expressions. These
forward-looking statements involve a number of risks and
uncertainties that may cause actual results or events to differ
materially from those expressed or implied by such forward-looking
statements. Factors that may cause actual results or events to
differ materially from those expressed or implied by these
forward-looking statements include, but are not limited to, risks
of obtaining future partner or grant funding for development of
MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient
capital when needed to fund MediciNova's operations and
contribution to clinical development, risks and uncertainties
inherent in clinical trials, including the potential cost, expected
timing and risks associated with clinical trials designed to meet
FDA guidance and the viability of further development considering
these factors, product development and commercialization risks, the
uncertainty of whether the results of clinical trials will be
predictive of results in later stages of product development, the
risk of delays or failure to obtain or maintain regulatory
approval, risks associated with the reliance on third parties to
sponsor and fund clinical trials, risks regarding intellectual
property rights in product candidates and the ability to defend and
enforce such intellectual property rights, the risk of failure of
the third parties upon whom MediciNova relies to conduct its
clinical trials and manufacture its product candidates to perform
as expected, the risk of increased cost and delays due to delays in
the commencement, enrollment, completion or analysis of clinical
trials or significant issues regarding the adequacy of clinical
trial designs or the execution of clinical trials, and the timing
of expected filings with the regulatory authorities, MediciNova's
collaborations with third parties, the availability of funds to
complete product development plans and MediciNova's ability to
obtain third party funding for programs and raise sufficient
capital when needed, and the other risks and uncertainties
described in MediciNova's filings with the Securities and Exchange
Commission, including its annual report on Form 10-K for the year
ended December 31, 2018 and its subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Undue reliance should not be
placed on these forward-looking statements, which speak only as of
the date hereof. MediciNova disclaims any intent or obligation to
revise or update these forward-looking statements.
INVESTOR CONTACT:Geoff O'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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