Central nervous system ((CNS)) disorder drug development is a particularly difficult branch of biopharma drug development. Intra-Cellular Therapies (ITCI) has experienced this firsthand, with inconsistent late-stage results for ITI-007 (Lumateperone), a promising therapy for certain CNS disorders. We have experienced this firsthand as biopharma investors too, with other companies such as Alkermes (ALKS), who have had high-profile drug failures due to inconsistent late-stage trial results. One particular issue for clinical trials for CNS disorders is controlling artificially high efficacy in the placebo arm.
ITCI has a number of binary events ahead this quarter,