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MediciNova Reports Results of a Phase 2b Clinical Trial of MN-221 in Asthma Exacerbations

Company Intends to Move Forward With End-of-Phase 2 Meeting With FDA and Phase 3 Clinical Development

Management to Host Conference Call to Discuss Results Today, May 23rd at 5:00pm (EDT)

SAN DIEGO, May 23, 2012 (GLOBE NEWSWIRE) -- MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (Trading Symbol: MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), today announced that preliminary results from a hospital emergency department (ED)-based Phase 2b clinical trial evaluating MN-221 in patients with acute exacerbations of asthma did not statistically meet the primary endpoint, improvement in FEV1 (Forced Expiratory Volume in One Second) compared to placebo. However, MN-221 showed a significant benefit over placebo for FEV1 (liters) Area Under the Curve (AUC Hour 0-1, 0-2, 0-3) of change from baseline (p=0.043, p=0.050, p=0.066 respectively) in the data set defined below.

The trial also demonstrated a reduction in hospital admissions with MN-221 added to standard drug treatments. Moreover, there was a significant improvement in clinical symptoms with MN-221 treated patients and the safety profile of MN-221 continues to be positive as no safety/tolerability issues of clinical significance were observed.

"Although we did not realize statistical significance in our pre-defined primary endpoint, MN-221 displayed the positive efficacy and safety data we expected to see," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova. "We believe certain variables, such as administration of off-protocol therapies, especially in the standard-of-care alone group (placebo arm) and somewhat higher-than-anticipated variability in measuring FEV1 values limited the MN 221 outcomes. Our goal is to control these variables going forward, enabling us to run a successful Phase 3 program.

Accordingly, we have filed our End-of-Phase 2 meeting request with the Division of Pulmonary, Allergy, and Rheumatology Products at FDA."

MediciNova intends to design pivotal trial(s) that will include technological and operational improvements and further controls for medications that are not typically used in the treatment of acute exacerbations of asthma and were over-represented in the standard-of-care only group in this study.

"Acute asthma exacerbations, which are asthma attacks not controlled by a patient's medications, represent a major cause of ED visits and hospitalizations for many of the 26 million people with asthma in this country," said lead investigator Dr. Lawrence Lewis, M.D., of Washington University and Barnes-Jewish Hospital in St. Louis, MO. "If the asthma attack can't be effectively treated in the ED, these patients are usually admitted to the hospital for further treatment, a costly alternative for patients and a significant drain on healthcare resources. Unfortunately, we are limited to only a few medications that have been shown to help in the emergency treatment of asthma exacerbation, and often the patient has already tried most of these medications at home. There is clearly an unmet need for more effective treatments for the emergency care of this condition. We are very pleased that MediciNova will continue development of MN-221 to address this unmet medical need."

The data set presented below includes more than 85% of the 164 efficacy evaluable patients in the trial. This includes patients from all of the sites that enrolled a minimally sufficient number of patients (greater than three) and for whom all efficacy data were available including FEV1, dyspnea, respiratory rate, and hospitalization.

Highlights of MN-221-CL-007 Trial:

 

-- Overall FEV1 improvement was better in the MN-221 treatment group than

the placebo and standard-of-care (SOC) alone group.

 

 

-- MN-221 showed a significant benefit over SOC alone for FEV1(L) Area

Under the Curve (AUC Hr 0-1, 0-2, 0-3) of change from baseline,

(p=0.043, p=0.050, p=0.066 respectively)

 

 

-- MN-221 showed a significant improvement in clinical respiratory

parameters including dyspnea score (shortness of breath).

 

 

-- MN-221 improved AUC (Hr 0-3) of change in dyspnea score by 34% more than

SOC alone (p=0.055)

 

 

-- Fewer patients were hospitalized in the MN-221 treatment group than

standard-of-care (SOC) alone group.

 

 

-- MN-221 reduced the overall hospitalization rate by 17% vs. SOC alone

 

 

-- There were no significant clinical safety concerns when adding MN-221 to

standard treatments.

 

 

Positive improvements support further development of MN-221 as detailed in the following tables.

 

 

Table 1: FEV1 (L)

---------------------------------------------------------------------------

MN-221 Placebo Improvement

FEV1 (L) (n=73) (n=71) over placebo p-value

------------------ ----------- ----------- ----------------- ----------

AUC ( Hr 0-1) 0.065 0.020 225% 0.043

------------------ ----------- ----------- ----------------- ----------

AUC ( Hr 0-2) 0.231 0.085 172% 0.050

------------------ ----------- ----------- ----------------- ----------

AUC ( Hr 0-3) 0.435 0.240 81% 0.066

------------------ ----------- ----------- ----------------- ----------

Note: non-parametric analysis; median values.

 

 

 

Table 2: Clinical Evaluation

---------------------------------------------------------------------

Improveme

nt

MN-221 Placebo over

(n=71) (n=70) placebo p-value

---------------------- ---------- ---------- --------- ----------

Dyspnea Score,

AUC (hr 0-3) -5.00 -3.72 34% 0.055

---------------------- ---------- ---------- --------- ----------

Dyspnea Score,

AUC (hr 0-2) -2.59 -1.88 38% 0.062

---------------------- ---------- ---------- --------- ----------

 

---------------------- ---------- ---------- --------- ----------

Respiratory Rate,

AUC (hr 0-3) -1.83 -0.14 1.69 0.170

---------------------- ---------- ---------- --------- ----------

Respiratory Rate,

AUC (hr 0-2) -1.24 0.23 1.47 0.108

---------------------- ---------- ---------- --------- ----------

 

---------------------- ---------- ---------- --------- ----------

Hospital admissions 38% 46% 17% NS

---------------------- ---------- ---------- --------- ----------

Note: ANCOVA analysis; mean values. NS = Not significant.

 

 

"We are very encouraged to see confirmation of improved respiratory and clinical outcomes of MN-221 above the standard therapies, consistent with current practice guidelines," said Dr. Kazuko Matsuda, Chief Medical Officer, MediciNova. "In addition, there were no discontinuations due to treatment-emergent adverse events in the patient population."

With regards to safety/tolerability findings, other than asthma-related events, there were only three serious adverse events in the study including one case of bronchitis in the placebo group, one case of bronchitis in the MN-221 group, and one case of pneumonia in the MN-221 group.

Conference Call/Webcast Information

MediciNova will host a conference call today, Wednesday, May 23rd at 5:00pm (EDT) and audio webcast to present results followed by a question and answer session with members of management. Management on the call will include Dr. Yuichi Iwaki, the President and Chief Executive Officer, Michael Coffee, the Chief Business Officer, Dr. Kirk Johnson, the Chief Scientific Officer, Dr. Kazuko Matsuda, Chief Medical Officer, and Michael Gennaro, the Chief Financial Officer.

To participate in this call, dial 800-901-5213 (domestic), 617-786-2962 (international), passcode: 55684644, shortly before 5:00 P.M. (EDT).

For a limited period following the call, a replay of the call will be available, beginning at 7:00 P.M. (EDT); the replay can be accessed by calling 888-286-8010 (domestic), 617-801-6888 (international),

passcode: 62649061. The audio webcast will be available on MediciNova's investor relations website (http://investors.medicinova.com) for a brief period following the call.

About MN-221-CL-007

MN-221-CL-007 was a randomized, double-blind, placebo-controlled Phase

2 clinical trial which enrolled 175 patients in the United States. The trial enrolled patients who presented to the emergency department with an acute exacerbation of asthma and did not initially respond to complete standard-of-care pharmacotherapy including inhaled albuterol, inhaled ipratropium, and steroids. In order to be eligible for enrollment, patients needed to have baseline FEV1 (% predicted), after initial standard therapy, of <50% and therefore considered "severe"

exacerbation subjects. Enrolled patients were randomized 1:1 to placebo vs. 1200 micrograms MN-221 i.v. infused over 1 hour.

About MN-221

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 exacerbation is defined as an acute, long-lasting and severe asthma/COPD 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 (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.

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 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. 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.

The MediciNova, Inc. logo is available at

http://www.globenewswire.com/newsroom/prs/?pkgid=3135

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 our expectations on the ability to advance MN-221 through a successful 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 and expectations on future progress in the development of our drug candidates, 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 the preliminary results of the Phase 2 trial of MN-221 for the treatment of acute exacerbations of asthma, including the failure to meet the primary endpoint in the Phase

2 trial and the expected need to design the Phase 3 trial to mitigate against improved outcomes in the standard of care population and the uncertain outcome of the end of Phase 2 meeting with the FDA, 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 completion 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. 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:

Mark Johnson

Investor Relations

MediciNova, Inc.

(858) 373-1300

johnson@medicinova.com

MEDIA CONTACT:

Stephanie Ashe

Continuum Health Communications

650-245-0425

sashe@continuumhealthcom.com

 

Posted: May 2012

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