Harmony Biosciences to Present New Wakix (Pitolisant) Safety and Efficacy Data at Sleep 2023 Annual Meeting

Harmony Biosciences

PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), a pharmaceutical company, announced that 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 (PWS) will be highlighted as a poster presentation during a late-breaking abstract session at the 37th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as “SLEEP 2023,” in Indianapolis from June 3-7.

Additional presentations by Harmony include an oral presentation covering a pooled analysis of clinically meaningful improvements in adults with narcolepsy, as well as poster presentations detailing the results of a pharmacokinetics study of WAKIX in breast milk and serum in healthy lactating women, and an ongoing prospective observational safety study evaluating WAKIX exposure in pregnant women and their offspring.

“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,” said Harmony’s Chief Medical Officer, Kumar Budur M.D., M.S. “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.”

Dr. Budur added that the company is especially encouraged by the positive results from the Phase 2 proof-of-concept study in PWS 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.”

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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 TimeWednesday, June 7, 2023, at 4:30 – 4:45 p.m. EDT

  • Poster Presentation Date and TimeTuesday, June 6, 2023, at 5:00 – 6:00 p.m. EDT

Poster Board Number: 294

Poster: “Pharmacokinetics of Pitolisant in Breast Milk and Serum of Healthy Lactating Women.”

  • Poster Presentation Date and TimeTuesday, June 6, 2023, at 5:00 – 6:00 p.m. EDT

Poster Board Number: 232

Poster: “Pitolisant Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring.”

  • Poster Presentation Date and TimeTuesday, June 6, 2023, at 12:00 – 1:15 p.m. EDT

Poster Board Number: 231

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 TimeTuesday, June 6, 2023, at 5:00 – 6:00 p.m. EDT

Poster Board Number: 510

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