Vanda Pharmaceuticals has reported positive results from its safety and efficacy of tasimelteon (SET) Phase III study evaluating tasimelteon in the treatment of Non-24-Hour disorder, a rare circadian rhythm disorder.
Tasimelteon demonstrated the primary endpoint of entrainment of the melatonin (aMT6s) rhythm as compared to placebo in addition to demonstrating significant improvements across a number of sleep and wake parametres.
Vanda president and CEO Mihael Polymeropoulos said results indicate that tasimelteon is a strong circadian regulator capable of entraining the master body clock in patients with Non-24.
"We are particularly impressed and excited by the magnitude and robustness of the direct clinical benefits to patients," Polymeropoulos said.
"We believe that tasimelteon can be an effective and clinically meaningful treatment for patients suffering with this debilitating disorder."
Considerable improvements over placebo in the Non-24 Clinical Response Scale (N24CRS) in addition to the Clinical Global Impression of Change (CGI-C), an overall global functioning scale, were demonstrated by tasimelteon in the study.
These results provide evidence of a direct and clinically meaningful benefit of the novel therapy in treating patients suffering from the rare circadian rhythm disorder.
Tasimelteon was safe and well-tolerated in the SET study. Top-line results from the second Phase III study (RESET) for tasimelteon in Non-24 are expected in the first quarter of 2013.
The company anticipates submitting a new drug application for tasimelteon to the US Food and Drug Administration in mid 2013.