MediciNova Initiates Phase II Clinical Trial for MN-305, a Novel Treatment for Insomnia
- Category: Small Molecules
- Published on Wednesday, 24 January 2007 02:00
- Hits: 2103
SAN DIEGO, CA, USA | Jan 22, 2007 | MediciNova, Inc., a biopharmaceutical company that is publicly traded on NASDAQ (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced the initiation of a Phase II clinical study to determine the safety and efficacy of MN-305 for the treatment of insomnia.
MN-305 is a potent and highly-selective full agonist at the serotonin 5-HT1A receptor under development both for the treatment of insomnia as well as for anxiety disorders such as Generalized Anxiety Disorder (GAD). MN-305 has been evaluated in an extensive preclinical toxicology program which showed no evidence of mutagenicity, antigenicity or carcinogenicity. MN-305 has also proved to be consistently well-tolerated in clinical safety, efficacy and pharmacokinetic studies in over 1,200 subjects.
MediciNova intends to explore the potential of MN-305 as a treatment for insomnia based on clinical observations of a beneficial therapeutic effect on insomnia in patients with GAD. In a recently completed Phase II/III randomized, double-blind, placebo-controlled clinical trial of MN-305 in 416 patients with GAD, a statistically significant improvement in the insomnia item of the Hamilton Anxiety Rating Scale (HAM-A) was observed in patients treated with 0.5 - 6 mg of MN-305 per day. To further test this clinical finding, MediciNova will conduct a Phase II, randomized, double-blind, placebo-controlled, crossover dose-response study to assess the safety and efficacy of MN-305 in patients with primary insomnia with sleep maintenance difficulties. This study will assess the effects of three dosages of MN-305 (1 mg, 3 mg and 6 mg) and placebo, all administered orally approximately 60 minutes before bedtime in 75 subjects at approximately 10 study centers in the U.S.
"We believe that MN-305 represents a potentially unique approach to treating insomnia, a prevalent, yet under-treated condition," said Yuichi Iwaki, M.D., Ph.D., Executive Chairman and CEO of MediciNova, Inc. "The initiation of this study underscores our ability to rapidly translate clinical findings into proof-of-concept testing and our commitment to pursue significant market opportunities."
MediciNova acquired a license to MN-305 from Mitsubishi Pharma Corporation for global markets, with the exception of Japan and other selected Asian countries. The data acquired from Mitsubishi includes extensive preclinical and clinical safety results, including that from full carcinogenicity testing in rodents.
Although extremely prevalent, insomnia remains poorly diagnosed and treated. According to the U.S. Department of Health and Human Services, approximately 60 million Americans suffer from insomnia each year. Insomnia tends to increase with age and affects about 40 percent of women and 30 percent of men. Individuals suffering from insomnia exhibit at least one of the following symptoms:
- difficulty falling asleep (sleep onset or sleep induction)
- difficulty in staying asleep (sleep maintenance)
- early final awakening (sleep maintenance)
- nonrestorative sleep
These symptoms may be of short duration (acute) or lasting for more than 30 days (chronic), according to the consensus report from the NIH State of the Science Conference on Chronic Insomnia held in June 2005. Data from this conference showed that 30% of the general population had complaints of sleep disruption and 10% had symptoms of daytime functional impairment. In a 2005 National Sleep Foundation study, 54% of adults reported at least one symptom of insomnia a few times a week, and 33% had at least one symptom nightly or almost every night. Yet only 20% of patients with occasional insomnia and 33% with chronic insomnia mentioned it to their primary care physicians. Thus, there remains a significant unmet medical need for new therapeutic agents that are more effective, non-addicting and safe for chronic use.
MediciNova, Inc. is a publicly-traded biopharmaceutical company focused on accelerating the global development and commercialization of innovative pharmaceutical products. MediciNova's pipeline, which includes six compounds in clinical testing, targets a variety of prevalent medical conditions, including asthma, multiple sclerosis, status asthmaticus, interstitial cystitis, cancer, Generalized Anxiety Disorder, insomnia, preterm labor, urinary incontinence and thrombotic disorders. For more information on MediciNova, Inc., please visit www.medicinova.com.
This press release may contain "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include statements regarding clinical trials supporting efficacy of one of our product candidates as well as the potential novelty of that candidate as a treatment for disease. These statements are based on certain assumptions made by the Company's management that are believed to be reasonable at the time. Such statements are subject to a number of risks and uncertainties, many of which are beyond the control of the Company, including the results of clinical studies and other risks and uncertainties, including those described in the Company's filings with the Securities and Exchange Commission. These assumptions, risks and uncertainties could cause the Company's actual results to differ materially from those implied or expressed by the forward-looking statements.
SOURCE: MediciNova, Inc.