This morning, PWSA | USA received new information from Harmony Biosciences regarding its Phase 2 study of pitolisant. This study's purpose is to evaluate the safety and efficacy of the drug in patients with Prader-Willi syndrome (PWS). The company shared the following community-facing statement:
"Today, Harmony Biosciences announced topline data on the primary outcome, excessive daytime sleepiness, from our Phase 2 proof-of-concept trial in patients with Prader-Willi syndrome, or PWS. We are encouraged by this initial data, which will inform our plans to advance our clinical development program of pitolisant in patients with PWS. The full data set is expected before the end of the year.
The entire team at Harmony Biosciences would like to sincerely thank the people with PWS, their caregivers and families, and the clinical trial site personnel who participated in our study. We are grateful for their time and willingness to participate in clinical research."