Hyloris Announces Positive Study Results for Dofetilide IV
- New Drug Application (NDA) Expected to be Submitted to the U.S. Food & Drug Administration (FDA)
Liège, Belgium – 13 March 2025– 06.30 PM CET — Regulated Information – Inside information – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces positive results from a pivotal clinical study evaluating its proprietary Dofetilide IV. The study was designed to compare bioavailability between the intravenous (IV) and oral form of the drug (dofetilide) and to establish optimal dosing strategies, including the initial dose and timing to transition to oral therapy.
This key milestone supports the submission of a New Drug Application (NDA) of Dofetilide IV to the U.S. Food & Drug Administration (FDA) planned in the next months.
Thomas Jacobsen and Stijn van Rompay co-Chief Executive Officers of Hyloris commented: “We are delighted by the successful results of this study. Currently, patients starting dofetilide therapy typically require multiple days of hospitalization to ensure safe dosing and monitoring, primarily due to the need for gradual dose titration and continuous QT interval monitoring1. The introduction of Dofetilide IV has the potential to transform this treatment paradigm by enabling a faster and more controlled therapy initiation, potentially reducing hospital stays durations. This study provides essential data to guide dosing recommendations and optimize patient outcomes.”
[1] The QT interval is the part of a heart test (ECG) that shows how long it takes for the heart to contract and then reset for the next beat.