PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) this week 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.
“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.”
The 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.
The 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 inertia and cognitive impairment. Other outcomes, including patient impression of overall change in symptoms, investigator assessment of overall disease severity, and functional status will also be evaluated in the study.
Pitolisant is marketed as WAKIX® in the U.S. for the treatment of EDS or cataplexy in adult patients with narcolepsy. Pitolisant is not approved for IH and is currently being evaluated as an investigational agent in patients with IH.
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