PureTech Health (PRTC) said Monday that it completed the end-of-phase 2 meeting with the US Food and Drug Administration to develop deupirfenidone for the treatment of idiopathic pulmonary fibrosis.
The company said that the meeting was supported by results from the phase 2b ELEVATE IPF trial, in which participants treated with deupirfenidone experienced a slower rate of lung function decline versus those who were treated with pirfenidone or placebo.
PureTech's founded entity, Celea Therapeutics, expects to finalize financing in early 2026 to support the initiation of the phase 3 SURPASS-IPF trial in the first half of 2026.
The phase 3 trial will compare deupirfenidone to pirfenidone in adults with idiopathic pulmonary fibrosis who are not on background therapy, with the primary efficacy endpoint being the change from baseline in absolute forced vital capacity at week 52.
Based on feedback from the FDA, PureTech said it believes that successful results from the phase 3 trial could complete the data package required to support potential registration of deupirfenidone through a streamlined regulatory pathway.
The company's shares were down 4% in recent Monday premarket activity.