MediciNova Announces Presentation of Significant Positive Results from Interim Analysis of the Phase 2 Trial of MN-001 (tipel...
April 13 2018 - 6:30AM
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 presented the positive results from the interim analysis of
the Phase 2 clinical trial of MN-001 (tipelukast) in NASH
(non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty
liver disease) with hypertriglyceridemia at the International Liver
Congress 2018, the 53rd annual meeting of the European Association
for the Study of the Liver (EASL) in Paris, France. Highlights of
the presentation, entitled “The anti-fibrotic agent tipelukast
(MN-001) reduces serum triglycerides significantly in NASH and
NAFLD patients with hypertriglyceridemia after 8 weeks of
treatment, an interim analysis of clinical trial, MN-001-NATG-201”,
include the following:
- The data from the 15 subjects who completed 8 weeks of
treatment (250 mg /day for 4 weeks and 500 mg/day for 4 weeks) were
analyzed.
- After 8 weeks of treatment with MN-001, the serum triglyceride
level was reduced in 14 out of 15 subjects.
- Pre-treatment mean serum triglycerides was 328.6 mg/dL and
post-treatment mean serum triglycerides was 192.9 mg/dL. MN-001
significantly reduced mean serum triglycerides by 135.7 mg/dL,
resulting in a 41.3% reduction (p=0.02).
- The data from the 15 subjects who completed 8 weeks of
treatment was re-analyzed after excluding one outlier (subject 5019
RM with an extremely high triglyceride level of 1288 mg/dL before
treatment which was reduced to 300 mg/dL after treatment).
- After 8 weeks of treatment with MN-001, the serum triglyceride
level was reduced in 13 out of 14 subjects.
- Pre-treatment mean serum triglycerides was 260.1 mg/dL and
post-treatment mean serum triglycerides was 185.2 mg/dL. MN-001
significantly reduced mean serum triglycerides by 74.9 mg/dL,
resulting in a 28.8% reduction (p=0.00006).
- There were no clinically significant safety or tolerability
issues during the study.
MN-001 (tipelukast) significantly reduced mean serum
triglycerides, a primary endpoint, during the study. Having
achieved the most important endpoint of the study, MediciNova has
discontinued enrollment and will stop the study in order to
accelerate further development of MN-001. Yuichi Iwaki, MD, PhD,
President and Chief Executive Officer of MediciNova, Inc.,
commented, "We are thrilled with the results of this study, which
showed a large reduction in triglycerides. Based on the
results of this study along with the triglyceride data we have from
prior clinical studies of MN-001 in other indications, we believe
that MN-001 has potential to benefit a wide range of patients with
hypertriglyceridemia, not limited to those with NASH and
NAFLD.”
About the Trial
The Phase 2a trial is a multi-center, proof-of-principle,
open-label study designed to evaluate the efficacy, safety, and
tolerability of MN-001 in subjects with non-alcoholic
steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD)
with hypertriglyceridemia. Eligible subjects consisted of males and
females ranging in age from 21 to 65 years old, inclusive. To
be eligible, subjects must have had a histologically confirmed
diagnosis of NASH or imaging study confirmed NAFLD and an elevated
serum triglyceride (>150 mg/dL) during the Screening
Phase.
About MN-001
MN-001 (tipelukast) is a novel, orally bioavailable small
molecule compound thought to exert its effects through several
mechanisms to produce its anti-inflammatory and anti-fibrotic
activity in preclinical models, including leukotriene (LT) receptor
antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and
4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT
pathway has been postulated as a pathogenic factor in fibrosis
development and MN-001's inhibitory effect on 5-LO and the 5-LO/LT
pathway is considered to be a novel approach to treat fibrosis.
MN-001 has been shown to down-regulate expression of genes that
promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1.
MN-001 has also been shown to down-regulate expression of genes
that promote inflammation including CCR2 and MCP-1. In addition,
histopathological data shows that MN-001 reduces fibrosis in
multiple animal models.
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 multiple sclerosis (MS), amyotrophic
lateral sclerosis (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.
INVESTOR CONTACT:Geoff O'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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