SALT LAKE CITY, June 23 /PRNewswire-FirstCall/ -- Results from a phase II study presented this week demonstrated the effects of VEC-162 in a model of transient insomnia on the traditional measures of sleep onset and maintenance. VEC-162, an investigational agent under clinical development by Vanda Pharmaceuticals for the treatment of insomnia, is a novel melatonin agonist. The data were presented at the SLEEP 20th Anniversary Meeting of the Associated Professional Sleep Societies (APSS) by Dr. Shantha M.W. Rajaratnam, Division of Sleep Medicine, Brigham and Women's Hospital, Harvard Medical School.
A randomized, double-blind study of 37 healthy subjects was conducted to evaluate the efficacy of VEC-162 (10, 20, 50 and 100 mg) in a model of transient insomnia. The primary objectives of the study were to evaluate the efficacy of VEC-162 in shifting patients' circadian rhythm as measured by plasma melatonin and in improving time to persistent sleep as measured by polysomnography (PSG) when compared with placebo in a model of transient insomnia. Secondary objectives included wakefulness after sleep onset (WASO), safety and tolerability.
On circadian rhythm, there was a statistically significant (p<0.025) shift in circadian rhythm at 50 and 100 mg of up to 5 hours in the first night, and a statistically significant dose-response curve. On polysomnographic measures of sleep efficacy, all dosing arms experienced a reduction in time it took to achieve persistent sleep. The 10 mg dose improved by 23.4 minutes vs. placebo (p<0.004), the 20 mg improved 10.1 minutes (not significant), the 50 mg improved 18.8 minutes (p<0.02) and the 100 mg dose improved 19.3 minutes (p<0.03). All dosing arms experienced a reduction in wakefulness after sleep onset (WASO). There was a statistically significant (p<0.05) reduction in WASO at 100 mg of 68.5 minutes less than placebo. At 10 mg the reduction vs. placebo was 36 minutes, and at the 20 and 50 mg arms the reduction was 45 minutes. There was a statistically significant dose response in both sleep measures.
"We are encouraged by these clinical results," said Mihael Polymeropoulos, MD, CEO of Vanda, "which demonstrate that, in VEC-162, we may have the first therapy available to treat the millions of patients who suffer from the consequences of a misalignment of their sleep/wake cycle."
Treatment with VEC-162 was generally well tolerated in the study with the adverse events mild to moderate in nature.
Selected materials from the APSS presentation on the VEC-162 phase II study will be made available on Vanda's website, http://www.vandapharma.com. For more information relating to the VEC-162 phase II study, please refer to the final prospectus for Vanda's initial public offering filed on April pursuant to Rule 424(b)(4) under the Securities Act on April 13, 2006.
About VEC-162
VEC-162 is a novel compound currently in phase III development for the treatment of insomnia. The compound binds selectively to the melatonin-1 and melatonin-2 receptors of the superchiasmatic nuclei (SCN), which governs the body's sleep/wake cycle and circadian rhythm.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release, and the above-mentioned materials from Vanda's APSS presentation to be made available on Vanda's website, contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Vanda's plans for VEC-162 and its other product candidates. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," and "could," and similar expressions or words, identify such forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements may include, among others, a failure of VEC-162 or Vanda's other product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for VEC-162 or Vanda's other product candidates or to comply with ongoing regulatory requirements, a lack of acceptance of VEC-162 or Vanda's other product candidates in the marketplace, a failure of Vanda to become or remain profitable, Vanda's inability to obtain the capital necessary to fund its research and development activities, a loss of any of the company's key scientists or management personnel, and other factors that are described in the "Risk Factors" section of Vanda's report on Form 10-Q for the fiscal quarter ended March 31, 2006. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information contained in this press release and in the above-mentioned presentation materials are provided only as of the date of this release, and Vanda undertakes no obligation to update any forward-looking statements contained in this release or such materials on account of new information or future events, except as required by law.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The Company has three product candidates in clinical development. Vanda's lead product candidate, iloperidone, is a compound for the treatment of schizophrenia and bipolar disorder and is in a Phase III clinical trial for schizophrenia. Vanda's second product candidate, VEC-162, is a compound for the treatment of insomnia and depression which is currently in a Phase III clinical trial for insomnia. Vanda's third product candidate, VSF-173, is a compound for the treatment of excessive sleepiness and is ready for a Phase II clinical trial. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.
Vanda Pharmaceuticals Inc.CONTACT: Steven A. Shallcross, SVP & CFO, +1-240-599-4500,sshallcross@vandapharma.com, or Chip Clark, SVP & CBO, +1-240-599-4500,chipclark@vandapharma.com, both of Vanda Pharmaceuticals Inc.
Web site: http://www.vandapharma.com//
