Business
HARMONY BIOSCIENCES ANNOUNCES ACCELERATED TIMELINE FOR PHASE 3 INTUNE STUDY IN IDIOPATHIC HYPERSOMNIA
Strong momentum in Phase 3 trial; enrollment ahead of schedule Expects to complete enrollment in the second quarter of 2023, just over one year from trial
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"Strong momentum in Phase 3 trial; enrollment ahead of schedule\n Expects to complete enrollment in the second quarter of 2023, just over one year from trial initiation\n Anticipates topline data in the fourth quarter of 2023\n\n\nPLYMOUTH MEETING, Pa., March 29, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (\"Harmony\" or the \"Company\") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced an accelerated timeline for completing its Phase 3 INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia (IH). The Company now expects to complete enrollment in the second quarter of 2023 with topline data anticipated in the fourth quarter of 2023.\n\n \n \n \n \n \n \n\n \n\"The strong interest we have seen from the IH patient community and our clinical investigators in this trial is indicative of the true unmet medical need for a non-scheduled, once-daily treatment option working through histamine to improve wakefulness for people living with IH,\" said Jeffrey M. Dayno, M.D., Interim Chief Executive Officer and Chief Medical Officer of Harmony. \"The momentum in this trial, as well as the growth of WAKIX in narcolepsy, reflects the positive experience of patients and the confidence of prescribers in this meaningfully differentiated product. Furthermore, we are confident in the strength of our underlying business and our ability to execute on our three-pillar growth strategy.\"\nThe results of a recent pre-specified interim sample size analysis by an independent data monitoring committee concluded that the study can continue with the original planned sample size. This, along with the pace of enrollment, confirms the accelerated timeline toward expected completion of the trial.\nThe INTUNE study is a double-blind, placebo-controlled, randomized withdrawal Phase 3 registrational trial in approximately 200 IH patients being conducted at about 60 clinical trial sites across the U.S. The primary objective is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in adult patients with IH. Secondary objectives of the study include the impact of pitolisant on other important symptoms of IH, such as sleep ine...