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This Phase II study examined the effects of VSF-173 on a model ofexcessive sleepiness among 55 healthy volunteers treated with 3 doses ofVSF-173 administered at 50 mg, 100 mg and 200 mg and placebo administered at25 mg, 50 mg and 100 mg at the usual bedtime and at four hours after the firstdose. In this model, the effect of the compound was evaluated with a series ofsix Maintenance of Wakefulness Tests (MWT) given two hours apart starting onehour after the first dose. The effect of the drug was also evaluated on thescheduled daytime recovery sleep following the night time and morningevaluations.
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On the primary endpoint which evaluated the effect of the compound on thefirst four series of MWT tests, VSF-173 demonstrated improvements overplacebo. The mean MWT sleep onset scores for the 50 mg, 100 mg and 200 mg, andplacebo groups were 10.3, 12.9, 10.6 and 9.2 minutes, respectively. While thepair-wise analysis did not reach statistical significance, this magnitude ofeffect, ranging from 1.1 to 3.7 minutes, is generally similar to that observedwith modafinil in the treatment of patients with narcolepsy.
In a subset of 37 subjects with no observed impairment in pre-dose daytimewakefulness (MWT cutoff equal to 30 minutes), the mean of all six MWT scoresfor the 50 mg, 100 mg and 200 mg groups showed improvements of 2.1, 3.4 and2.1 minutes, respectively, compared to placebo. For the dose group of 100 mg,this observation of improvement was statistically significant (p < 0.05).
Further evidence of the wake-promoting properties of VSF-173 was alsoobserved during the scheduled daytime recovery sleep following the night timeand morning evaluations. Statistically significant (p<.05; non-parametric)dose-dependent correlations were observed with the following polysomnography(PSG) parameters: increased number of awakenings, decreased sleep efficiencyand total sleep time for the first third of the sleep period, and increasedwake time after sleep onset for the first 3 hours of the sleep period.
These wake-promoting effects of VSF-173 on MWT and PSG measures suggestthat VSF-173 possesses a novel mechanism to address disorders of excessivesleepiness. Vanda plans to conduct additional studies to further understandtiming of administration, dose-response and appropriate populations to treat.VSF-173 was also demonstrated to be safe and well-tolerated.
"We are encouraged by the results of this proof-of-concept study onVSF-173," stated Mihael Polymeropoulos, M.D., President and CEO of Vanda. "Webelieve that the compound has the potential to address the symptoms ofexcessive sleepiness in the context of a number of disorders includingnarcolepsy and shift worker sleep disorder, as well as neurodegenerativedisorders."
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company with aparticular focus on the development and commercialization of clinical-stageproduct candidates for central nervous system disorders. The company has threeproduct candidates in clinical development. In addition to VSF-173, Vanda isdeveloping Iloperidone, a drug for schizophrenia, which has recently beensubmitted for marketing approval to the FDA, and VEC-162, a compound for thetreatment of sleep and mood disorders, which has recently initiated a PhaseIII study in primary insomnia. For more on Vanda Pharmaceuticals Inc., pleasevisit http://www.vandapharma.com.
Note Regarding Forward-Looking Statements
This release contains forward-looking stat
