MediciNova Announces Additional Results from the Completed Trial of MN-166 (ibudilast) in Alcohol Dependence to be Presented ...
May 25 2016 - 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 two
abstracts detailing novel findings from further analysis of the
completed clinical trial of MN-166 (ibudilast) in alcohol
dependence have been accepted for presentation at the 39th Annual
Scientific Meeting of the Research Society on Alcoholism to be held
June 25-29, 2016 at the Hyatt Regency New Orleans in New Orleans,
LA.
Presentation details for both abstracts are as
follows:
Session Date: Monday, June 27, 2016
Location: Hyatt Regency New Orleans, 601 Loyola
Avenue, New Orleans, LA 70113
Title (Abstract #322): Depressive
Symptomatology Moderates the Effects of the Neuroimmune Modulator
Ibudilast on Subjective Responses to Alcohol
Title (Abstract #323): Ibudilast increases
positive mood and decreases alcohol craving in individuals with
AUD
About the Clinical Trial
This randomized, double-blind, placebo-controlled study enrolled
24 non-treatment seeking individuals with either alcohol abuse or
dependence in a UCLA research unit. Participants were randomly
assigned to a 7-day treatment period involving repeat oral
administration of either MN-166 (ibudilast) escalated up to 100
mg/day or placebo. During the treatment period, participants were
administered the study medication, completed an IV alcohol
challenge, and took part in laboratory tests of alcohol craving as
well as mood surveys and standard safety tests. Following a
7-10 day study break, trial participants re-enrolled for another
7-day period wherein they crossed over to the other treatment
condition. The key study outcomes included safety,
tolerability and preliminary efficacy as indicated by whether
MN-166 (ibudilast) reduced alcohol craving under controlled
conditions.
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 licensed MN-166 (ibudilast) from Kyorin Pharmaceutical
Co., Ltd. for potential utility in RRMS. Intellectual property was
additionally established or obtained by MediciNova in progressive
MS and other neurological conditions. 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 amyotrophic lateral sclerosis (ALS), also known
as Lou Gehrig’s disease), substance abuse/addiction and chronic
neuropathic pain.
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 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., methamphetamine dependence and 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, 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, 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, 2015 and its subsequent periodic
reports on Forms 10-Q and 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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