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MediciNova Announces Positive Findings From a Completed Phase 2 Trial of MN-166 (ibudilast) in Opioid Dependence at the Behavior, Biology and Chemistry: Translational Research in Addiction Meeting in San Antonio, Texas

LA JOLLA, Calif., March 06, 2016 (GLOBE NEWSWIRE) -- 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 the presentation of results based on the completed study which evaluated the safety and efficacy of MN-166 (ibudilast) in opioid dependence at a symposium titled, “Glial and Neuroinflammatory Modulators for Attenuating Some Abuse-Related Effects of Drugs,” at the Behavior, Biology and Chemistry: Translational Research in Addiction Meeting held on March 5, 2016.

Sandra Comer, Ph.D., Professor, Department of Psychiatry, Columbia University and New York State Psychiatric Institute (NYSPI), presented results of the completed Phase 2 trial which evaluated MN-166 (ibudilast) in patients with opioid dependence.

Major highlights from the presentation, “Ibudilast for Treating Opioid Use Disorder: Laboratory Studies in Humans,” include the following:

  • Ibudilast significantly decreased the reinforcing effects of oxycodone (p <0.05);

  • Ibudilast significantly decreased craving for heroin (p <0.01), cocaine (p <0.01), and tobacco (p <0.05);

  • Ibudilast significantly decreased participants’ rating for “liking” oxycodone (p <0.05);

  • Ibudilast significantly enhanced the analgesic effects of oxycodone (p <0.05);

  • Ibudilast was safe and well-tolerated by the participants.

In addition, Keith Heinzerling, M.D., M.P.H., Associate Professor, Department of Family Medicine and Medical Director of the UCLA Center for Behavioral and Addiction Medicine, presented at the plenary session the rationale for how MN-166 (ibudilast) may work as a treatment for patients with methamphetamine dependence.

Yuichi Iwaki, M.D., PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased with the encouraging efficacy results reported in Dr. Comer’s study, particularly ibudilast’s ability to reduce the craving for heroin, and ibudilast’s positive safety and tolerability results reported at BBC. We are now considering the next step in the development process to further evaluate ibudilast’s potential utility in the treatment of opioid dependence.”

About the Opioid Dependence Clinical Trial

The study was a randomized, placebo-controlled, double-blind, inpatient Phase 2 study of MN-166 (ibudilast) in opioid-dependent abusers of prescription opioids and/or heroin. The study duration was approximately 6 weeks per subject. The crossover study design included initial detoxification followed by randomization to ibudilast 50 mg twice a day or placebo. Subjects were maintained on each dose for at least 2-3 consecutive weeks (1 week stabilization + 1.5 week testing). During test weeks, participants received oxycodone (0, 15, or 30 mg) in random order on separate days. For each dose, a sample followed by a choice session was completed. During the choice session, a “drug versus money” self-administration paradigm was employed. The primary aim of the study was to investigate the ability of MN-166 to alter the reinforcing, analgesic, subjective, performance, and physiological effects of oxycodone, a commonly abused prescription opioid.

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 for potential utility in relapse-remitting multiple sclerosis (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 ALS), 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, 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, 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

Source:MediciNova, Inc.