MediciNova Announces Positive FDA Feedback Regarding Phase 3 Plan for MN-166 (ibudilast) in ALS
September 25 2018 - 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 it has received
positive feedback from the FDA (U.S. Food and Drug Administration)
regarding MediciNova’s Phase 3 clinical development plan for MN-166
(ibudilast) in amyotrophic lateral sclerosis (ALS).
Key points from the FDA’s feedback include the
following:
- If a single trial shows that MN-166 (ibudilast) has a
statistically significant benefit compared to placebo in a measure
of functional activity, such as ALSFRS-R, an additional trial may
not be necessary.
- In order to detect the maximal potential benefit of MN-166
(ibudilast), FDA encouraged including a broad ALS population, with
randomization that is stratified by baseline disease severity.
- No safety issues regarding MN-166 (ibudilast) were raised by
the FDA and the safety profile will be revisited once the pivotal
results are available.
- Given that the indication is for ALS, a rare disease, there may
be flexibility in the requirements to support a marketing
application.
Yuichi Iwaki, MD, PhD, President and Chief
Executive Officer of MediciNova, Inc., commented, "We are
excited to receive the green light from FDA to proceed with Phase 3
development of MN-166 for ALS. We will finalize the study design
according to FDA’s feedback."
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) has been marketed in Japan and
Korea since 1989 to treat post-stroke complications and bronchial
asthma. MediciNova is developing MN-166 for progressive multiple
sclerosis (MS) and other neurological conditions such as ALS and
substance abuse/addiction. MN-166 (ibudilast) is a first-in-class,
orally bioavailable, small molecule phosphodiesterase (PDE) -4 and
-10 inhibitor and a macrophage migration inhibitory factor (MIF)
inhibitor that suppresses pro-inflammatory cytokines and promotes
neurotrophic factors. It attenuates activated glia cells, which
play a major role in certain neurological conditions. Ibudilast's
anti-neuroinflammatory and neuroprotective actions have been
demonstrated in preclinical and clinical study results and provide
the rationale for its therapeutic utility in neurodegenerative
diseases (e.g., progressive MS and ALS), substance abuse/addiction
and chronic neuropathic pain. MediciNova has a portfolio of patents
which cover the use of MN-166 (ibudilast) to treat various diseases
including progressive MS, ALS, and drug addiction.
About MediciNova
MediciNova, Inc. is a publicly-traded
biopharmaceutical company founded upon acquiring and 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 MS, ALS
and substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence) 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) for the
treatment of acute exacerbations of asthma and MN-029 (denibulin)
for solid tumor cancers. MediciNova is engaged in strategic
partnering and other potential funding discussions to support
further development of its programs. 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-221, MN-001, 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-221, MN-001, 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, 2017 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.
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INVESTOR
CONTACT: |
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Geoff O'Brien |
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Vice President |
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MediciNova, Inc. |
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info@medicinova.com |
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