SAN DIEGO, Aug. 23, 2012 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), announced positive preliminary results of a Phase 1b clinical trial involving multiple administrations of intravenous (IV) MN-221 (bedoradrine) over several days in patients with stable, moderate-to-severe chronic obstructive pulmonary disease (COPD). The majority of the subjects completed the study and there were no clinically significant safety concerns. In addition, preliminary pharmacokinetic and efficacy findings were encouraging.
"We are very pleased with the positive safety data and early efficacy findings for MN-221," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "These results add important value to our ongoing strategic development of our pivotal clinical program for MN-221 and we look forward to discussing this data at our upcoming End-of-Phase 2 meeting with the FDA's respiratory division in late October."
A total of 25 subjects were randomized to placebo (5 subjects) or MN-221 (20 subjects) treatment groups; with similar enrollment at each of two clinical research units. The patient group included those who had concomitant illnesses and were using other medications that are typical in this disease population.
Preliminary efficacy results indicated moderately improved pulmonary function (FEV1) in the MN-221 recipients but not the placebo recipients. Moreover, the improvement of FEV1 on subsequent MN-221 dosing days was as good as or better than on Day One. Regarding other strategic objectives, comparison of the simple hand-held FEV1 monitor with the spirometer machine used in our other clinical trials of MN-221 indicated good correlation and pharmacokinetic analyses indicated no significant accumulation of plasma MN-221 over the multiple dosing intervals.
"There is a significant unmet medical need for an IV agent like MN-221 for asthma and COPD patients who are admitted to the ER due to a severe episode that is unresponsive to standard therapy," said Kazuko Matsuda, M.D., Ph.D., M.P.H, Chief Medical Officer. "The results of this trial will help us optimize both the trial design and operational considerations for our pivotal program in acute asthma exacerbations."
About the trial design
The Phase 1b trial design involved baseline safety and lung function testing on Day One followed by a one-hour intravenous infusion of placebo or 1200 micrograms MN-221. Safety, pharmacokinetic, and respiratory performance measurements were taken for the remainder of the day. Following a clinical investigator's evaluation early on Day Two, subjects received a treatment infusion every 12 hours through the morning of Day Four. Subjects were monitored until discharge on the morning of Day Five following a clinical investigator's examination. Clinical trial subjects received six treatment infusions over four days.
There were no additional safety concerns with repeat dosing. Two MN-221 recipients with pre-existing heart disorders were terminated from the study on the first day of dosing due to transient arrhythmias identified by electrocardiograph monitoring that did not have clinical symptoms or consequences and resolved spontaneously.
MN-221 is a novel, highly selective beta(2)-adrenergic receptor agonist in development for the treatment of acute exacerbations of asthma and COPD. An acute asthma or COPD exacerbation is defined as a long-lasting and severe episode that is not responsive to the standard bronchodilator or corticosteroid therapy. Patients with an asthma/COPD exacerbation typically go to the emergency room (ER) for treatment. If treatment in the ER is not successful, the patient may be admitted to the hospital.
Current inhaled beta-agonist treatments for asthma and COPD exacerbations are limited by bronchoconstriction or insufficient airflow due to inflammation and airway constriction, reducing the amount of inhaled drug that can get into the lungs. In addition, the amount of inhaled treatments a patient can tolerate is limited due to the potential for cardiovascular side effects, such as increased heart rate.
MN-221 is designed to treat acute exacerbations via intravenous infusion, bypassing constricted airways to deliver the drug directly to the lungs. Preclinical studies showed MN-221 to have a high affinity for the beta(2)-adrenergic receptor, found primarily in the lungs, and a much lower affinity for the beta(1)-adrenergic receptor found primarily in cardiac tissue. These studies showed no worrisome increase in heart rate when MN-221 was administered.
MN-221's improved delivery to the lungs and its cardiac safety profile may help fill an unmet need for patients with asthma or COPD exacerbations, helping them to breathe easier and avoid a costly hospital stay.
MediciNova acquired an exclusive, worldwide (excluding Japan), sublicensable license to MN-221 from Kissei Pharmaceutical Co., Ltd.
MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need 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 coverage 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) for neurological disorders. MN-221 is involved in clinical trials under U.S. INDs. MN-166 is being developed in Phase 1b/2 trials for pain and drug addiction, largely through Investigator INDs and outside funding. Proof-of-concept Phase 2b trial(s) in Progressive MS are pending receipt of non-dilutive funding. MediciNova is engaged in strategic partnering and consortium funding discussions to support further development of both the MN-221 and ibudilast/MN-166 programs. Additionally, MediciNova will seek to monetize opportunistically 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 the benefits of the preliminary data from the COPD trial, regarding our expectations on the ability to advance MN-221 through a Phase 3 trial, expectations about our end of Phase 2 meeting with the FDA, expectations about the trial design for a Phase 3 trial and our implied expectation that we will be able to obtain additional financing to fund a Phase 3 clinical trial, progress, expectations for the ibudilast/MN-166 programs and expectations on future progress in the development of our drug candidates, expected timing of clinical trial results and any implication as to the results of our development, partnering and funding efforts or that the company will have the ability to execute on its priorities. 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, risks and uncertainties inherent in clinical trials including 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 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, risks relating to the operations of the joint venture in China, 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, 2011 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:Mark JohnsonInvestor RelationsMediciNova, Inc.(858) 373-1300johnson@MediciNova.comMEDIA CONTACT:Stephanie AsheContinuum Health Communications650firstname.lastname@example.org