Harmony Biosciences Holdings Inc will present new safety and efficacy data from a phase 2 proof-of-concept study evaluating pitolisant for the treatment of excessive daytime sleepiness in patients with Prader-Willi syndrome at SLEEP 2023 in Indianapolis from June 3 to 7. 

Additional presentations by Harmony include an oral presentation covering a pooled analysis of clinically meaningful improvements in adults with narcolepsy.

“As a company dedicated to developing and delivering treatments for rare neurological disorders, we are pleased to share a broad range of data for pitolisant at this year’s SLEEP meeting,” says Harmony’s chief medical officer, Kumar Budur, MD, in a release. “These data add to the growing body of scientific evidence that has been generated for pitolisant to help further characterize its safety, tolerability, and clinical utility.”

Budur adds in the release that the company is especially encouraged by the positive results from the phase 2 study in Prader-Willi syndrome in anticipation of an upcoming phase 3 registration trial.

“Together, the data presented at SLEEP 2023 demonstrate Harmony’s commitment to expanding the clinical utility of pitolisant for adult patients with narcolepsy while rigorously pursuing new indications for treating patients with unmet medical needs in other rare neurological disorders,” Budur says in the release.

The following data presented by Harmony will be available in the meeting’s gallery:

Oral and Poster: “Clinically Meaningful Improvements with Pitolisant in Adults with Narcolepsy: Pooled Analysis of Randomized Clinical Trials.”

  • Oral Presentation Date and Time: Wednesday, June 7, 2023, from 4:30 to 4:45 pm EDT
  • Poster Presentation Date and Time: Tuesday, June 6, 2023, from 5 to 6 pm EDT

                    Poster Board Number: 294

Poster: “Primary Efficacy and Safety Results of a Phase 2 Double-Blind, Placebo-Controlled Proof of Concept, Signal Detection Study of Pitolisant in Prader-Willi Syndrome.”

  • Poster Presentation Date and Time: Tuesday, June 6, 2023, from 5 to 6 pm EDT

                    Poster Board Number: 510

Wakix (pitolisant) is a first-in-class medication approved by the US Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy and has been commercially available in the US since Q4 2019.