FDA Clears Pharmosa Biopharm's Inhaled Drug L608 for Phase 2 Trial
核心洞察
Pharmosa Biopharm (搜索) said the FDA has cleared its long-acting inhaled candidate L608 to begin a Phase 2 trial in systemic sclerosis digital ulcers (搜索).
The randomized, double-blind, controlled trial plans to enroll 40 patients over a 28-day treatment period, with enrollment targeted for completion by early 2028.
L608 pairs iloprost with a long-acting liposome formulation and a handheld inhaler from subsidiary Puren Pharmaceutical (搜索), allowing at-home self-administration.
Pharmosa Biopharm (搜索) announced that the U.S. Food and Drug Administration has approved its long-acting inhaled drug candidate L608 to proceed with a Phase 2 clinical trial in systemic sclerosis digital ulcers (搜索) (SSc-DU). The company expects to initiate the trial by the end of this year and aims to complete patient enrollment by early 2028.
The Phase 2 study uses a randomized, double-blind, controlled design and plans to enroll 40 patients over a 28-day treatment period. Pharmosa said it will run the trial across multiple countries and centers to validate L608 in peripheral vascular complications of scleroderma, with the aim of generating proof-of-concept data that can support international licensing collaborations and later Phase 3 development.
L608 uses iloprost as its active pharmaceutical ingredient, formulated as an inhaled product through Pharmosa's long-acting liposome technology. Iloprost is recommended in EULAR guidelines for peripheral vascular manifestations of scleroderma but is currently given by intravenous infusion, which requires five consecutive days of hospitalization with six-hour infusions daily. The inhaled route is intended to maintain efficacy while allowing patients to complete treatment at home. The delivery device was developed by Pharmosa subsidiary Puren Pharmaceutical (搜索), and the company said this is the first time its own drug and its own device have entered U.S. clinical development together. L608 holds Orphan Drug Designation from both the FDA and the European Medicines Agency (搜索).
Source: Pharmosa Biopharm's Inhaled Drug L608 Wins FDA Approval for Phase 2 Trial