WASHINGTON, June 17, 2013 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) presented additional
data today at ENDO 2013, the Endocrine Society's 95th
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 for Non-24.
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 chronic therapy.
"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 School.
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.
About Tasimelteon
Tasimelteon is a circadian regulator in development for the
treatment of Non-24. Tasimelteon is a dual melatonin receptor
agonist (DMRA) with selective agonist activity at 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 U.S.
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 www.vandapharma.com.
Company Contact:
Jim
Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contact:
Laney Landsman
Assistant Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com
SOURCE Vanda Pharmaceuticals Inc.