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MediciNova Announces New Strategic Initiative

SAN DIEGO, June 26, 2007 (PRIME NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced that based on recent clinical successes and evaluation of market opportunities, it will focus its resources on development and commercialization of two key assets in its development pipeline, MN-221 and MN-166. MediciNova believes that MN-221, now in Phase IIa clinical testing, has the potential to become the new standard of care for the treatment of severe, acute exacerbations of asthma (status asthmaticus) in emergency facility settings. Data from the Phase IIa trial is expected during the fourth quarter of 2007. MN-166, an oral treatment for multiple sclerosis, demonstrated positive clinical benefits and a superior safety profile after one year of treatment in a two-year randomized, double-blind, placebo-controlled Phase II trial in 297 relapsing multiple sclerosis patients.

Adhering to its strategy to focus investment on key assets such as MN-221 and MN-166, and in order to bring these assets substantially forward towards commercialization, MediciNova will limit its expenditures on other development programs to only those activities necessary to maximize each asset's value, while aggressively pursuing a variety of initiatives to monetize these development programs. As part of this strategy, MediciNova will discontinue development of MN-001 in its current immediate-release formulation. As such, the current Phase III trial of MN-001 in bronchial asthma patients will be stopped. To date, approximately 200 patients have been enrolled in that trial with no reported serious adverse events. The formulation currently being tested requires a multiple dosing per day schedule. Market and competitive analyses point to the desire for a once-a-day therapy for bronchial asthma and, thus, MediciNova will continue its work on developing a once-a-day preparation of MN-001. MediciNova anticipates that this reallocation of resources will provide substantial cash savings over the next 12 months.

"MediciNova's strategy has always been to select and develop product candidates that fill an unmet medical need and offer competitive market advantages. To that end, we have built an attractive pipeline that provides us with multiple opportunities from which to realize value," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "In focusing our resources, we are in the enviable position to dedicate investment to two commercially attractive development candidates that we can potentially commercialize on our own with a small, focused sales force, while we simultaneously continue efforts to monetize the remainder of our pipeline through business development initiatives, including potential partnering opportunities. We believe this new strategy will provide even greater value in the realization of our key clinical assets."

The anti-inflammatory and neuroprotective oral agent MN-166 (ibudilast) shows an excellent safety profile at 60 mg/day and provides significantly prolonged time-to-first relapse and attenuated brain volume shrinkage in patients with relapsing-remitting (RR) and/or secondary progressive (SP) multiple sclerosis (MS).
Sponsor trial coordinator Richard E. Gammans, PhD, Chief Development Officer, MediciNova Inc., San Diego, California, presented the findings from a multicenter, randomised, double-blind, placebo-controlled, phase 2 study here on October 12 at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

"Pharmacologically, MN-166 has mechanisms that include anti-inflammatory effects, such as phosphodiesterase inhibition, and neuroprotective effects, such as inhibition of [nitric oxide] synthesis and reduction in reactive oxygen species," he said. This study was thus designed to evaluate the effects of MN-166 in patients with MS.

The study enrolled patients aged 18 to 55 years who were diagnosed with RRMS or SPMS using McDonald criteria, with continued relapses. They had one or more Gd-enhancing lesion on MRI scan taken 2 weeks before treatment start; and expanded disability status scale (EDSS) no greater than 5.5 at screening. The main exclusion criteria were based around no use of various immunosuppressants within 6 months, or of interferons -- corticosteroids and adrenocorticotropic hormone -- within 45 days of the initial magnetic resonance imaging (MRI) scan.

The primary endpoint was cumulative active lesions on MRI. The secondary endpoints were clinical relapse and other MRI measures.

Of 967 patients screened, 100 were randomized to placebo, 94 were randomized to 30 mg/day of MN-166, and 96 were randomized to 60 mg/day of MN-166 for the first 12 months of treatment, with clinical and MRI evaluations every 2 months. The 12-months extension phase was designed to evaluate the effects of continuation of MN-166 dosing, with placebo patients switched to MN-166 30 mg/day or 60 mg/day.

Baseline clinical characteristics across these three treatment groups were similar for percent RRMS, percent spinal or cerebrum location of lesions, and number of relapses in previous 24 months. There were indications that time since both MS diagnosis and onset of symptoms were longer in the treated groups (39, 50, 60 months; 73, 96, 98 months; respectively).

In terms of primary outcome of cumulative active lesions over the first 12 months, there was no significant difference amongst treatments. However, there was a modest difference between the highest dose of MN-166 and placebo, with an 18% reduction in cumulative active lesions, although this difference was not significant, indicated Dr. Gamman.

Similarly, there were no significant differences between treatment group in the percent of patients with sustained disability progression on EDSS (8.0%, 5.3%, 4.1%).

In contrast, for other MRI assessments over the 12 months, MN-166 at 60 mg/day showed not only a significant improvement in the percentage of brain volume reduction (P =.035), but also a significant increase in the median time to first relapse (P =.04). Thus, the percentage of patients who were relapse-free at year 1 was significantly greater at the higher MN-166 dose (41% vs 41.5% vs 56.0% (P =.03).

Dr. Gammans said that MN-166 was very well tolerated, with 89% of patients completing the first 12 months of treatment. "The side effects were generally mild, and resolved without intervention, and there were no adverse observations on laboratory or [electrocardiographic] findings as well," he added.

When the two MN-166 treatment groups were combined, gastrointestinal side effects were the only adverse events to occur at 2-fold or greater times those of placebo (7.6% vs 14.7% vs 22.2%), although tolerance to these effects occurred rapidly (2-4 days). There were no deaths in the study.

Due to these modest effects of MN-166 on inflammatory lesion counts and based on its pharmacology, Dr. Gamman said that the clinical benefits of MN-166 60 mg/day arise primarily from its actions towards protection of neurons from damage, rather than towards reduction of inflammatory lesions.

At the same time, the excellent safety profile at 60 mg/day and the effects that reached significance in this study suggest that future studies with MN-166 should evaluate higher doses on disease progression and MRI measures of neuroprotection, rather than inflammation.

Funding for this study was provided by MediciNova Inc.

Source: Presentation title: Clinical Effect of the Neuroprotectant MN-166 in Relapsing Forms of MS. Abstract 52 (15/10/07