Liquidia Corporation announced that it has initiated the ASCENT open-label safety and tolerability study of Yutrepia (LIQ861) treprostinil DPI in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The 52-week study is expected to enroll 60 PH-ILD patients.
The FDA tentatively approved Yutrepia for the treatment of pulmonary arterial hypertension (PAH) in November 2021. In July 2023, Liquidia submitted an sNDA to extend the use of the DPI to PH-ILD. The agency accepted the sNDA without requiring any additional clinical trial data and has set a PDUFA goal date for the sNDA as January 24, 2024. Final approval of the sNDA would be delayed until at least March 24 due to patents covering United Therapeutics’ Tyvaso inhaled treprostinil.
Liquidia also announced that it held a Type C meeting with the FDA regarding L606 liposomal treprostinil inhalation suspension in December 2023 and said that the agency agreed that a 505(b)(2) NDA for the inhalation suspension would need to be supported by only one Phase 3 trial in PH-ILD patients. The company said that it expects to initiate that study later this year and is continuing to enroll PAH and PH-ILD patients in an ongoing safety study of L606. Liquidia acquired the North American rights to L606 from Pharmosa Biopharm in June 2023.
Liquidia Chief Medical Officer Rajeev Saggar commented, “Yutrepia will provide practitioners and patients the opportunity to comfortably use a low-resistance dry-powder inhaler across a wide range of doses to a broad range of patients with PAH and PH-ILD with varying lung function and clinical severity. We are also pleased by the increasing interest to enroll patients in the L606 open-label study. The real-time data on patient tolerability, dosing titration, and clinical response will greatly inform the pivotal efficacy trial and should provide additional confidence in the benefits of more consistent, sustained exposures over a 24-hour period.”
Read the Liquidia press release.
