MediciNova Announces Plans to Develop MN-166 (ibudilast) for Severe Pneumonia and Acute Respiratory Distress Syndrome (ARDS)
March 09 2020 - 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 it plans
to initiate development of MN-166 (ibudilast) for severe pneumonia
and acute respiratory distress syndrome (ARDS). MediciNova’s
decision to pursue development of this indication was based on
positive results of a recent preclinical study in an animal model
of ARDS (Med Sci Monit, 2020; 26: e922281). Results of this
preclinical study showed that ibudilast treatment reversed
histological changes observed in the ARDS mouse model including
inflammation, hemorrhage, alveolar congestion, and alveolar wall
edema. In this study, the pulmonary edema score was used to assess
the degree of lung water accumulation. Importantly, pulmonary
edema was significantly reduced by ibudilast treatment
(p<0.001). Results of this study also showed that ibudilast
significantly reduced the levels of inflammatory cytokines
including TNF-alpha (p<0.001), IL-1beta (p<0.001), IL-6
(p<0.001), and MCP-1 (p<0.001) in a dose-dependent manner,
indicating that ibudilast suppressed the inflammatory response.
Results of this study also suggest that ibudilast protects against
pulmonary injury by attenuating cell apoptosis in lung tissue.
Yuichi Iwaki, M.D. Ph.D., President and Chief Executive Officer
of MediciNova, Inc., commented, “We are very pleased to announce
our initiation of development of MN-166 for severe pneumonia and
ARDS. Severe pneumonia and ARDS are very serious conditions which
are often caused by viral infections and often are fatal in
hospitalized patients. Considering the global outbreak of influenza
and coronavirus, it’s very important to develop an efficient and
safe treatment for these conditions. We believe that MN-166 has
great potential for the treatment for severe pneumonia and ARDS
patients based on its anti-inflammatory mechanism and strong
results from the ARDS animal model study.”
About Acute Respiratory Distress
Syndrome
Acute respiratory distress syndrome (ARDS) is a serious lung
condition that causes low blood oxygen. In ARDS, fluid builds up
inside the tiny air sacs of the lungs, and surfactant breaks down.
Surfactant is a foamy substance that keeps the lungs fully expanded
so that a person can breathe. These changes prevent the lungs from
filling properly with air and moving enough oxygen into the
bloodstream and throughout the body. The lung tissue may scar and
become stiff. ARDS may develop over a few days, or it can get worse
very quickly. The first symptom of ARDS is usually shortness of
breath. Other signs and symptoms of ARDS are low blood oxygen,
rapid breathing, and clicking, bubbling, or rattling sounds in the
lungs when breathing. Infections are the most common risk factors
for ARDS. These infections may include the flu, coronavirus or
other viruses, and sepsis. The rate of death in the hospital
is approximately 40% for ARDS patients.
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. Our earlier human studies demonstrated significant
reductions of serum MIF level after treatment with MN-166
(ibudilast). It also 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 degenerative cervical myelopathy
(DCM), glioblastoma, substance abuse/addiction, and
chemotherapy-induced peripheral 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), degenerative cervical myelopathy (DCM), 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, 2019 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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