Pharmosa Biopharm held an investor conference yesterday (4th), announcing that its long-acting inhaled drug candidate L606—independently developed and licensed to U.S.-based Liquidia (LQDA)—delivered strong Phase III results, demonstrating stable efficacy with minimal side effects. For regulatory strategy, both the U.S. FDA and the European EMA have agreed that L606 will require only one global Phase III trial in PH-ILD (the RESPIRE study) to simultaneously support NDA and MAA submissions for both PAH and PH-ILD indications in the U.S. and Europe. This decision significantly enhances development efficiency and broadens future market coverage, accelerating global commercialization.
L606 utilizes advanced liposomal sustained-release technology that allows the drug to remain in the lungs longer while maintaining stable plasma concentrations, effectively overcoming the common decline in therapeutic effect seen with traditional inhaled therapies during nighttime. Results from the Phase III clinical study showed that the improvement in the 6-minute walk distance was nearly identical at trough and peak levels (+24.3 meters and +22.5 meters, respectively). This clearly indicates consistent drug efficacy throughout both daytime activity and nighttime rest, greatly improving patients’ quality of life and treatment reliability.
Compared with currently marketed products Tyvaso and Tyvaso DPI, L606 demonstrates a disruptive advantage in both safety and convenience. Clinical data show that only 14% of patients experienced mild cough, significantly lower than Tyvaso’s 54% and Tyvaso DPI’s 35%. Systemic side effects such as dyspnea, fatigue, nausea, and dizziness occurred in only 3.6% of patients, markedly lower than Tyvaso’s rates for headache (34%), nausea (21%), dyspnea (18%), and upper respiratory tract infection (18%).
In addition, L606 requires only twice-daily inhalation to achieve therapeutic effect and achieved a high 48-week completion rate of 86%, demonstrating strong patient compliance and long-term safety—offering a new treatment option for patients living with chronic pulmonary hypertension.
According to market research, the population of PH-ILD patients is approximately two to three times that of PAH, yet available treatment options remain limited. Among treatment-naïve PH-ILD patients, L606 achieved a substantial median improvement of +65.6 meters and an average improvement of +45.7 meters in the 6-minute walk test—performance that significantly exceeds current therapies, opening access to a vast, untapped market.
With both indications representing a combined global market value exceeding NT$100 billion, and supported by Liquidia’s strong commercialization capabilities, L606 is well positioned to rapidly capture market share once launched.
Resource: 國邑長效吸入新藥L606三期報喜 將加快進入千億市場
