MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market MNOV +13.27% and the Jasdaq Market of the Osaka Securities Exchange (4875), announced initiation of a Phase 1b clinical trial with MN-221 in patients with stable, moderate-to-severe chronic obstructive pulmonary disease (COPD) involving multiple administrations of intravenous (i.v.) MN-221 over several days in typical patients with concomitant illnesses. The trial is scheduled to commence enrollment by the end of the year.
The clinical trial will be run under an existing Investigational New Drug (IND) application for MN-221 and has completed FDA review. The main focus of the trial will be to test the safety of repeat administration over several days of MN-221 in patients suffering from moderate-to-severe COPD. Efficacy evaluation will include various respiratory parameters including forced expiratory volume in 1 second (FEV1). The patient profile will include subjects with other common illnesses (and associated medications) encountered in the COPD population including diabetes and cardiovascular complications. Study subjects will receive repeat-dose i.v. infusions of 1200 µg of MN-221 or placebo under close medical supervision. MediciNova anticipates that optimal treatment of COPD exacerbations with MN-221 may require the repeat dose option.
“In collaboration with our partner Kissei Pharmaceutical Co. Ltd., we are pleased to continue development of MN-221 in patients with COPD. We believe there remains an unmet medical need for a safe and effective treatment for COPD exacerbations. Inhaled beta2-adrenergic agonists, which are the current standard of care, are often inadequate to control the symptoms of COPD exacerbations,” said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. “We anticipate that this trial will provide the safety and efficacy data necessary to enable MN-221 to be used in a manner that impacts not only the acute episode, but offers benefit for those subjects transitioned into inpatient and intensive care units.”
About MN-221
MN-221 is a novel, highly selective, beta(2)-adrenergic receptor agonist in development as an intravenous treatment for acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD) exacerbations. Preclinical testing in vitro and in vivo shows MN-221 to be more selective for the beta(2)-adrenergic receptor than other beta(2)-adrenergic receptor agonists commonly used for acute exacerbations of asthma. This improved selectivity, coupled with its partial agonist activity at beta(1)-adrenergic receptors, may yield bronchodilation without harmful cardiovascular side effects that are commonly observed with other agents. MediciNova has completed several Phase 1 and 2a trials, and is currently conducting a Phase 2b study in patients with acute exacerbations of asthma. MN-221 demonstrated significant improvements in FEV1 in all asthma trials as well as a 45% decrease in the hospitalization rate when added to current standard of care in a Phase 2a study of acute asthma patients in the emergency room. MediciNova also completed a Phase 1b clinical study of MN-221 in patients with stable, moderate to severe COPD in which MN-221 demonstrated clinically significant improvements in FEV1 with no clinically relevant safety concerns.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of serious diseases with a commercial focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential, and patent assets having claims of commercially adequate scope. MediciNova’s pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, chronic obstructive pulmonary disease exacerbations, multiple sclerosis and other neurologic conditions, asthma, interstitial cystitis, solid tumor cancers, Generalized Anxiety Disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova’s current strategy is to focus on its two prioritized product candidates, MN-221 for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations and ibudilast (MN-166/AV411) for the treatment of multiple sclerosis, chronic pain, spinal cord injury, or drug addiction. Each drug candidate is involved in clinical development under U.S. and Investigator INDs and MediciNova is engaged in strategic partnering discussions to support further development of the MN-221 and ibudilast programs. Additionally, MediciNova will seek to monetize its other pipeline candidates. For more information on MediciNova, Inc., please visit www.medicinova.com .
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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 development and partnering strategy. 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,” 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, the risks and uncertainties relating to risks inherent in clinical trials, product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, 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 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, cost and design of future clinical trials and research activities, 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 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, 2010 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.
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SOURCE: MediciNova, Inc.
CONTACT: MediciNova, Inc.
Mark Johnson, Investor Relations
(858) 373-1300
info@MediciNova.com
