MediciNova Announces Partnership with BARDA to Develop MN-166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-in...
March 09 2021 - 4:00PM
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
partnered with the Biomedical Advanced Research and Development
Authority (BARDA), part of the Office of the Assistant Secretary
for Preparedness and Response at the U.S. Department of Health and
Human Services, to repurpose MN-166 (ibudilast) as a potential
medical countermeasure (MCM) against chlorine gas-induced lung
damage such as acute respiratory distress syndrome (ARDS) and acute
lung injury (ALI). Under the Division of Research, Innovation, and
Ventures’ (DRIVe) Repurposing Drugs in Response to Chemical Threats
(ReDIRECT) program, BARDA will provide funding for proof-of-concept
studies of MN-166 in preclinical models of chlorine gas-induced
acute lung injury. MN-166 is the first compound to receive BARDA’s
development support through the DRIVe ReDIRECT program.
Kazuko Matsuda, M.D., Ph.D., M.P.H., Chief
Medical Officer of MediciNova, Inc., commented, “On behalf of the
entire MediciNova team, we are grateful for the opportunity to
partner with BARDA in an effort to repurpose MN-166 as a rapidly
administered treatment for patients exposed to chemical agents such
as chlorine. MN-166 attenuated histological changes observed in an
ARDS animal model, including pulmonary edema in lung tissue, and
protected against pulmonary injury by reducing cellular apoptosis
in lung tissue. Considering that pulmonary edema is a hallmark
feature of exposure to chlorine, MN-166 has the potential to
improve health outcomes and save lives. To date, more than 800
research participants have been treated with high-dose MN-166 in
MediciNova’s clinical trials. MN-166 has shown a benign safety and
tolerability profile.”
This project has been funded in whole or in part
with Federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and
Response; Biomedical Advanced Research and Development Authority,
under Contract No. 75A50121C00022.
About MN-166MN-166 is a small
molecule compound that inhibits phosphodiesterase type-4 (PDE4) and
inflammatory cytokines, including macrophage migration inhibitory
factor (MIF). It is in late-stage clinical development for the
treatment of neurodegenerative diseases such as ALS (amyotrophic
lateral sclerosis), progressive MS (multiple sclerosis), and DCM
(degenerative cervical myelopathy), and also for glioblastoma, CIPN
(chemotherapy-induced peripheral neuropathy), and substance use
disorder. In addition, MN-166 is being evaluated in patients with
COVID-19 that are at risk for developing ARDS.
About ReDIRECT BARDA
established the ReDIRECT project to repurpose commonly available
therapeutics as MCMs against chemical threats (e.g., cyanide,
opioids, nerve agents, chlorine, sulfur mustard, etc.). During a
chemical emergency, minutes matter and a rapid response is
necessary to save lives and reduce the incidence of adverse health
effects. Drug repurposing is a strategy that is used to identify
new uses for FDA approved or late-stage investigational
therapeutics outside of their original clinical indication. The
identification of existing and commonly available therapeutics for
repurposing as MCMs holds the potential to expand current response
capabilities to chemical threats and strengthen the United States’
preparedness posture.
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), as well as prevention of acute
respiratory distress syndrome (ARDS) caused by COVID-19, 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 to the development of formulations as well as the
initiation and conduct of 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, 2020 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'Brien |
Vice President |
MediciNova, Inc. |
info@medicinova.com |
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