John Gregory Dean's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q4 2024
Question
John Gregory Dean, on behalf of Frank Brisebois, asked for the rationale behind the high confidence in Pitolisant HD's likelihood of success in idiopathic hypersomnia (IH) patients.
Answer
Dr. Kumar Budur, Chief Medical and Scientific Officer, explained the confidence stems from two factors. First, the original INTUNE study showed clear efficacy in the open-label phase. Second, a body of evidence from all pitolisant trials demonstrates a clear dose-response and exposure-response relationship. He also noted the new trial will use a more straightforward parallel-arm design, aiding data interpretation.