PureTech Health PLC (NASDAQ:PRTC) dropped 8.1% in Monday’s premarket trading after providing an update on its End-of-Phase 2 discussions with the FDA regarding deupirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF).
The company said regulators are supportive of moving into a pivotal Phase 3 study and pursuing a 505(b)(2) regulatory pathway through its Founded Entity, Celea Therapeutics. Still, the market reacted to the extended timeline, as the planned Phase 3 SURPASS-IPF trial is not slated to begin until the first half of 2026.
The SURPASS-IPF study will be a global, randomized, double-blind trial comparing deupirfenidone 825 mg three times daily with pirfenidone 801 mg three times daily in adults with IPF who are not receiving background therapy. The primary endpoint will track the change in forced vital capacity (FVC) after 52 weeks of treatment.
PureTech also pointed to encouraging findings from the Phase 2b ELEVATE IPF study, where patients on deupirfenidone 825 mg experienced slower lung-function decline relative to pirfenidone and placebo. At 26 weeks, the deupirfenidone group demonstrated a 91 mL FVC advantage versus placebo.
Sven Dethlefs, CEO of Celea Therapeutics, said, “The forthcoming Phase 3 SURPASS-IPF trial builds on the strong foundation established by the Phase 2b ELEVATE IPF trial, which demonstrated deupirfenidone’s robust and durable treatment effect as a monotherapy and its potential to become a new standard of care.”
Celea expects to secure financing in early 2026 to initiate the pivotal trial, which PureTech believes could complete the data package required for potential approval via the 505(b)(2) pathway if results prove successful.