Vanda Pharmaceuticals Inc. Presents Data On Phase III Clinical Trial In Totally Blind Patients

Vanda Pharmaceuticals Inc. announced data presented at SLEEP, show that 70% of totally blind people with sleep complaints suffer from Non-24-Hour Disorder (Non-24). Non-24 is a circadian rhythm disorder characterized by a chronically misaligned body clock. The results underscore the need for a new therapy that can regulate the circadian clock and keep it synchronized with the 24-hour day. There are currently no FDA approved medications for the treatment of Non-24. In a poster presentation entitled, 70% of Totally Blind People with Sleep Complaints Are Not Entrained to the 24-Hour Clock, data were reported on the endogenous circadian period (T) for the first 143 subjects enrolled in the ongoing SET study (Safety and Efficacy of Tasimelteon to Treat Non-24), a Phase III clinical trial in totally blind patients. Circadian period was calculated by measuring a urinary melatonin metabolite and secretion rates, collected weekly for 48 hours (at four-eight hour intervals), for each of the four collection periods. Vanda used this objective evaluation of melatonin secretion by the pineal gland to determine circadian period. Of the 143 totally blind subjects with sleep complaints in the study, 70% were found to not be entrained to a 24-hour day and, as a result, diagnosed with Non-24. Circadian period in Non-24 patients ranged from 24.08 to 25.34, with a median tau of 24.45 (24 hours and 27 minutes), meaning study subject's internal clocks delay a median of 27 minutes every day.