Tasimelteon was shown for the first time to reset the body clock and to align it to a constant 24-hour day in patients suffering from Non-24-Hour Sleep-Wake Disorder (Non-24-Hour Disorder), according to Vanda Pharmaceuticals Inc. Tasimelteon is a circadian regulator in development for the treatment of Non-24-Hour Disorder in totally blind individuals with no light perception.
This observation was made in four patients during the initial run-in segment of the RESET study. RESET is a Phase III study of the maintenance effect of tasimelteon in the treatment of Non-24-Hour Disorder. Vanda intends to enroll a total of 20 tasimelteon responders in this study.
"We are extremely excited by this finding as it provides us with evidence that tasimelteon is able to reset the body clock in patients with Non-24-Hour Disorder," said Mihael H. Polymeropoulos, MD, president and CEO of Vanda Pharmaceuticals.
Circadian regulation is necessary for the treatment of Non-24-Hour Disorder and it is predictive of a beneficial effect on both nighttime sleep and daytime naps. While light resets the body clock in sighted individuals, keeping it synchronized with the 24-hour day, this effect is lost in totally blind individuals with no light perception.
Vanda is currently studying the efficacy of tasimelteon in Non-24-Hour Disorder in two Phase III studies, SET and RESET, which are ongoing and expected to be completed by the end of 2012.
