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 will
initiate a clinical trial of MN-166 (ibudilast) for acute
respiratory distress syndrome (ARDS) caused by COVID-19
(Coronavirus Disease 2019).
The study will be conducted by Yale’s Advanced Therapies Group,
which is co-directed by Richard Bucala, M.D., Ph.D., Chief,
Rheumatology, Allergy & Immunology at Yale School of Medicine
and Rheumatologist-in-Chief at Yale New Haven Health. Dr.
Bucala, is credited with the cloning of MIF (macrophage migration
inhibitory factor) and its receptor and led prior efforts targeting
MIF in autoimmunity and in cancer.
The lead Principal Investigator (PI) for this trial is Dr.
Geoffrey Chupp, Professor of Medicine (Pulmonology), Director of
the Yale Center for Asthma and Airway Disease and Director of the
Pulmonary Function Laboratory at Yale-New Haven Hospital. The
co-investigators include Dr. Maor Sauler, a physician scientist in
Pulmonary and Critical Care Medicine who specializes in adult
critical care including acute lung injury and sepsis, and Dr. Insoo
Kang, Director, Allergy & Immunology, who are also members of
the COVID-19 Advanced Therapeutic Group.
“We are very excited to partner with MediciNova to pursue this
novel approach for the treatment of lethal inflammation in COVID-19
patients,” commented Dr. Richard Bucala. “This study is especially
gratifying because MN-166’s inhibition of MIF activity was
discovered in Yale Pharmacology by Elias Lolis, Ph.D. We
believe MN-166 has the potential to reduce the mortality of
COVID-19 by limiting the hyperinflammation and ARDS associated with
severe cases.”
Dr. Geoffrey Chupp commented, “We are very pleased to have the
opportunity to study MN-166 in COVID-19-induced ARDS patients and
look forward to initiating treatment. We currently have
approximately 200 COVID-19 patients at Yale with 34 on ventilators.
We are hopeful that MN-166 will help patients with the most
severe cases of COVID-19.”
Yuichi Iwaki, M.D. Ph.D., President and Chief Executive Officer
of MediciNova, Inc., commented, “We are very pleased to announce
initiation of a clinical trial of MN-166 in ARDS caused by
COVID-19. This study also will allow investigators to determine the
optimal dose and route of administration in these very critical
patients.”
About Acute Respiratory Distress
Syndrome
Acute respiratory distress syndrome (ARDS) is a frequently
lethal lung condition caused by excessive inflammation for which
there are no effective therapies beyond supportive care. Normally,
the lung exchanges oxygen for carbon dioxide in small airway sacs
called alveoli. In ARDS, there is extensive inflammation and tissue
injury in the alveoli of the lungs, and loss of the surfactant, a
substance necessary for keeping alveoli open. These changes prevent
the lungs from filling properly with air and providing the body
with enough oxygen, causing life-threatening difficulty breathing.
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, shallow, and/or
rapid breathing. Infections are the most common cause of
ARDS. These infections may include the flu, coronavirus,
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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