Harmony Biosciences announces topline results from the INTUNE study

Harmony Biosciences announced topline results from the INTUNE study in patients with idiopathic hypersomnia. Kumar Budur, M.D., Chief Medical Officer at Harmony Biosciences said, “We are very encouraged by the magnitude of the response seen in the initial open-label treatment period, where 83% of patients completing this phase responded with an average 9.4 point improvement in the Epworth Sleepiness Scale. Equally encouraging is the number of patients, almost 90%, electing to continue into the long-term extension study, allowing us to generate additional safety and efficacy data in this patient population. Positive trends in other important outcomes like sleep inertia add to the totality of evidence that pitolisant has a clinical benefit for patients with IH.” The INTUNE study was a Phase 3 placebo-controlled, double-blind, randomized withdrawal study. Approximately 83% of patients who completed the 8-week open-label treatment period with pitolisant were responders and experienced a robust clinical response, with an average ESS change from baseline of – 9.4 points. A positive trend favoring pitolisant was observed during the 4-week double-blind randomized withdrawal period, however no statistically significant difference was observed between pitolisant and placebo groups on ESS, the primary endpoint. Positive trends favoring pitolisant were also observed across additional prespecified endpoints including the IHSS, which approached statistical significance, as well as on the SlQ. Further data analyses are being conducted. Approximately 88% of patients in the study continued into a 12-month long-term extension study, which is ongoing. The safety and tolerability profile of pitolisant in adult patients with idiopathic hypersomnia was consistent with the established safety profile and no new safety signals were observed.