PHARMOSA BIOPHARM’s licensing partner Liquidia (LQDA) recently announced at the 20th Annual Wells Fargo Healthcare Conference 2025 that the development of its inhaled therapy L606 is progressing actively. Liquidia has confirmed with regulatory authorities the clinical requirements for filing drug approvals in the U.S. and Europe. Data on efficacy and safety from the ongoing U.S. open-label Phase III trial will be disclosed during the company’s upcoming R&D Day. In addition, the global Phase III trial for PH-ILD (pulmonary hypertension associated with interstitial lung disease) is scheduled to start before the end of the year, allowing simultaneous submission for both PAH (pulmonary arterial hypertension) and PH-ILD indications.

At the conference, Liquidia provided a detailed update on L606, highlighting its latest clinical progress, global competitive advantages, and core market positioning. Following the recent market approval of Yutrepia, a short-acting inhaled dry powder therapy, the company is now actively planning L606’s regulatory and commercial development.

Liquidia confirmed that it has coordinated with major global regulatory authorities on the clinical requirements for U.S. and European submissions for L606. In addition to completed pharmacokinetic studies and the ongoing U.S. open-label Phase III trial, the completion of a global randomized controlled Phase III trial for PH-ILD will enable simultaneous applications for both PAH and PH-ILD indications.

The U.S. open-label Phase III trial includes patients transitioned from Tyvaso therapy and a subset of PH-ILD patients. Efficacy and safety results from this study will be presented at Liquidia’s R&D Day. The global PH-ILD Phase III trial, expected to start by year-end, will further establish the clinical competitiveness of L606 in terms of safety and efficacy.

Liquidia selected PH-ILD as the primary indication for the global Phase III trial because Tyvaso is only approved in the U.S., leaving a significant unmet medical need globally. Coupled with Liquidia’s strong collaboration with international physician networks, patient recruitment for PH-ILD is expected to proceed faster than for PAH.

During the conference, Liquidia emphasized L606’s clinical advantages. Current data suggest that L606’s liposomal formulation reduces upper respiratory side effects, such as throat irritation, improving patient tolerability and adherence. Some patients reported improved breathing in the early morning, likely due to a sustained-release effect from nighttime dosing, indicating that twice-daily dosing provides both immediate and prolonged therapeutic benefits.

Regarding dosing and competitive positioning, Liquidia noted that attention has focused on dose frequency and device selection. L606 employs twice-daily nebulized administration with liposomal sustained-release technology, reducing peak concentrations and narrowing peak-to-trough fluctuations, offering stable 24-hour drug coverage. For patients with pulmonary hypertension, the difference between once- or twice-daily dosing is minimal, but L606’s comfortable, user-friendly design may help improve clinical outcomes.

In market comparisons, Liquidia emphasized that L606’s clinical value is based on long-term efficacy and tolerability rather than simple comparisons of dosing frequency or device type. L606 demonstrates the potential to replicate the clinical benefits of intravenous therapy, providing continuous improvements in patient outcomes regardless of disease severity.

Resource: 國邑*授權夥伴Liquidia宣示L606開發全面啟動，目標雙適應同時申請上市