Vanda Presents Data From Phase III Studies that Demonstrate Tasimelteon
Restores Daily Cortisol Rhythm In Blind Patients With Non-24-Hour Disorder
Data presented at ENDO 2013, the Endocrine Society's 95th Annual Meeting
WASHINGTON, June 17, 2013
WASHINGTON, June 17, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda)
(NASDAQ: VNDA) presented additional data today at ENDO 2013, the Endocrine
Society's 95^th Annual Meeting, demonstrating that tasimelteon can entrain
(synchronize) both melatonin and cortisol rhythms. This effect further
confirms tasimelteon's potential to reset the master body clock and address
the circadian desynchrony which is inherent in Non-24-Hour Disorder (Non-24).
The SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal
study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder)
Phase III studies were designed to assess the safety, efficacy and maintenance
effect of tasimelteon for Non-24. Currently there is no approved FDA treatment
The simultaneous entrainment of both melatonin and cortisol reinforces
tasimelteon as a circadian regulator, resetting the master body clock in the
suprachiasmatic (SCN) nucleus. Cortisol is a key regulatory hormone which
exhibits a strong circadian rhythm, usually rising in the early morning and
falling in the evening. The circadian regulation of cortisol is necessary for
the human body to be prepared for a wide range of daily activities and
physiologic functions, including blood pressure variation, utilization of
fatty acids, circulating lymphocytes and immunity.
"In addition to entrainment of melatonin, entrainment of cortisol establishes
tasimelteon as a circadian regulator, addressing an unmet need for people
living with Non-24, a debilitating circadian rhythm disorder," said Mihael H.
Polymeropoulos M.D., Vanda's President and Chief Executive Officer.
In the SET study, tasimelteon achieved the primary endpoints of entrainment
(synchronizing) of the melatonin (aMT6s) rhythm as compared to placebo and
clinical response as measured by entrainment plus a score of greater than or
equal to 3 on the Non-24 Clinical Response Scale (N24CRS). Tasimelteon also
demonstrated significant improvement versus placebo across a number of sleep
and wake parameters including measures of total sleep time, nap duration, and
timing of sleep, as well as in the Clinical Global Impression of Change
(CGI-C), an overall global functioning scale. In treated patients, daytime
naps decreased by 46 minutes per day in the worst 25% of days in a cycle and
nighttime sleep increased by 57 minutes per day during the worst 25% of nights
in a cycle.
The RESET study demonstrated that continued treatment with 20mg of tasimelteon
was required to maintain entrainment of melatonin and cortisol circadian
rhythms in individuals with Non-24. Patients treated with tasimelteon
maintained their clinical benefits while patients who received placebo showed
significant deterioration in measures of nighttime sleep, daytime naps and
timing of sleep. Furthermore, discontinuation of tasimelteon resulted in a
rapid relapse to misaligned circadian rhythms, reinforcing the importance of
"These results clearly demonstrate that tasimelteon can entrain the circadian
clock and is able to align melatonin and cortisol rhythms to the 24-hour
social day," said Steven W. Lockley, Ph.D., Associate Professor of Medicine,
Division of Sleep Medicine, Brigham and Women's Hospital, Harvard Medical
About Non-24-Hour Disorder
Non-24 is a serious, rare, and chronic circadian rhythm disorder characterized
by the inability to entrain (synchronize) the master body clock with the
24-hour day-night cycle. Non-24 affects the majority of totally blind
individuals, or between 65,000 and 95,000 people in the U.S. Non-24 occurs
almost entirely in individuals who lack the light sensitivity necessary to
entrain the master body clock in the brain with the 24-hour day-night cycle.
Most people have a master body clock that naturally runs longer than 24-hours
and light is the primary environmental cue that resets it to 24-hours each
day. Individuals with Non-24 have a master body clock that continually
delays, resulting in prolonged periods of misalignment between their
circadian rhythms and the 24-hour day-night cycle, including the timing of
melatonin and cortisol secretion and the sleep-wake cycle. As a result of
this misalignment, Non-24 is associated with significant impairments in social
and occupational functioning, and marked subjective distress. For more
information on Non-24, please visit www.Non-24.com.
Tasimelteon is a circadian regulator in development for the treatment of
Non-24. Tasimelteon is a dual melatonin receptor agonist (DMRA) with
selective agonist activityat the MT1 and MT2 receptors.^ Tasimelteon's
ability to reset the master body clock in the suprachiasmatic nucleus (SCN)
results in the entrainment of the body's melatonin and cortisol rhythms with
the 24-hour day-night cycle. The patent claiming tasimelteon as a new
chemical entity extends through December 2022, assuming a 5-year extension to
be granted under the Hatch-Waxman Act. Tasimelteon has been granted orphan
drug designation for the treatment of Non-24 from both the U.S. and the
European Union. A new drug application (NDA) was filed for tasimelteon in the
About Vanda Pharmaceuticals Inc.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of products for the treatment of central
nervous system disorders. For more on Vanda, please visit
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
Assistant Vice President
SOURCE Vanda Pharmaceuticals Inc.
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