On the 23rd, Pharmosa Biopharm announced that its new inhalation drug, L608, has successfully completed Phase I clinical trials in Australia, demonstrating strong safety and tolerability even at the highest dosage, with no serious adverse events reported.

Pharmosa stated that, in addition to ongoing plans to design a Phase II clinical trial for treating Type 1 Pulmonary Arterial Hypertension (PAH), L608 has been granted orphan drug status by the U.S. FDA for the treatment of scleroderma. The company plans to leverage the Phase I trial data to conduct a Pre-IND meeting with the FDA by the end of this year. This meeting will focus on designing clinical trials for treating Systemic Sclerosis-Related Raynaud's Phenomenon and Digital Ulcers (SSc-RP/DU) and facilitate subsequent IND applications.

Further details from Pharmosa indicated that in the Australian Phase I trial of the PAH-targeted inhalation drug L608, 64 healthy participants received doses up to a maximum of 40 mcg, with no serious adverse events (SAEs) observed in any participants.

Resource (mandarin): 國邑新藥試驗報捷