MediciNova Announces Publication of Positive Findings from Completed Phase 1b Clinical Trial of MN-166 (ibudilast) in Methamphetamine Dependence

LA JOLLA, Calif., March 30, 2016  -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the medical journal Drug and Alcohol Dependence has published a new article regarding positive findings from a completed Phase 1b clinical trial of MN-166 (ibudilast) in methamphetamine dependence.  The article, which was written by Matthew J. Worley, Keith G. Heinzerling, and colleagues at the University of California, Los Angeles (UCLA), reports that MN-166 (ibudilast) was shown to significantly reduce the subjective effects of methamphetamine in subjects diagnosed with methamphetamine dependence.

Major findings from the publication, “Ibudilast attenuates subjective effects of methamphetamine in a placebo-controlled inpatient study,” include the following:

 

MN-166 significantly reduced the prototypical subjective effects of methamphetamine, such as “high” (How high are you?) (p<0.01), “effect” (Any drug effect?) (p<0.001), and “good” (Any good effects?) (p<0.05);

MN-166 also showed a reduction in subjective effects such as “stimulated” (How stimulated do you feel?) and “like” (How much do you like the drug?).

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased that the detailed results of the first clinical trial evaluating MN-166 in methamphetamine-dependent subjects have been published.  Based on the reported positive findings from this study, we continue to work in collaboration with researchers at UCLA on a much larger ongoing Phase 2 clinical study to evaluate MN-166 in methamphetamine-dependent subjects."  

 

About the Ongoing Clinical Trial

 

The study is a randomized, placebo-controlled, double-blind, outpatient Phase 2 study of MN-166 (ibudilast) in treatment-seeking methamphetamine-dependent subjects (n=140).  Eligible participants are randomized, stratified by HIV serostatus, to ibudilast 50 mg twice a day or placebo treatment for 12 weeks, with twice weekly clinic visits for counseling, urine drug tests, and safety/medication adherence monitoring.   The study is designed to detect a statistically significant benefit of MN-166 over placebo on the primary study outcome of methamphetamine abstinence during the final two weeks of treatment.

 

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.

 

Contact:

 

INVESTOR CONTACT: 

Geoff O'Brien

Vice President

MediciNova, Inc.

This email address is being protected from spambots. You need JavaScript enabled to view it.