May. 20 at 11:05 PM
$PRTC PureTech Health presents deupirfenidone data at ATS conference
PureTech Health delivered a late-breaking, oral presentation at the 2025 American Thoracic Society international conference in San Francisco. The presentation provided further insights into the Phase 2b ELEVATE IPF trial of deupirfenidone, highlighting the strength and durability of deupirfenidone's treatment effect through at least 52 weeks while maintaining favorable tolerability in patients living with idiopathic pulmonary fibrosis. Data presented from PureTech's global Phase 2b randomized, double-blind, active- and placebo-controlled, dose-ranging ELEVATE IPF trial demonstrated the potential for deupirfenidone to offer a differentiated treatment option for patients with IPF.
In the trial, patients treated with deupirfenidone 825 mg three times a day experienced a slower rate of lung function decline, as measured by Forced Vital Capacity, at 26 weeks versus those who were treated with placebo. This statistically significant difference represents a robust treatment effect versus placebo of 80.9% for deupirfenidone 825 mg TID as a monotherapy. This result compares favorably against the rate of decline in FVC observed in the trial among patients treated with pirfenidone 801 mg TID versus placebo, which was consistent with previously reported pirfenidone clinical trial data and represents a treatment effect of 54.1%.
Taken together, these results indicate that the treatment effect with deupirfenidone 825 mg TID was approximately 50% greater than that of pirfenidone 801 mg TID, based on their respective reductions in lung function decline versus placebo. In addition to these findings, deupirfenidone 825 mg TID also demonstrated a statistically significant benefit in delaying time to IPF progression4 compared to placebo, further supporting the clinical relevance of the treatment effect. Importantly, the rate of FVC decline observed over 26 weeks with deupirfenidone 825 mg TID was similar to the expected natural decline in lung function in healthy older adults. Furthermore, preliminary data from the ongoing open-label extension study suggest that this treatment effect is durable out to at least 52 weeks.
As of May 9, a total of 101 patients had received at least 52 weeks of treatment with deupirfenidone. Those in the deupirfenidone 825 mg TID arm experienced a decline in FVC of -32.8 mL over the 52-week period, which is similar to the expected natural decline in lung function in healthy older adults over one year. These new data provide additional support for the durability of the treatment effect observed with this dose and reinforce its potential to stabilize lung function decline over time, while maintaining favorable safety and tolerability. Additional details from the ongoing OLE are expected to be shared in a future scientific forum. These results are further supported by preliminary pharmacokinetic data, which underscore the differentiated profile of deupirfenidone.
Compared to pirfenidone 801 mg TID, deupirfenidone 825 mg TID resulted in an approximately 50% increase in drug exposure. Notably, the dramatically increased drug exposure did not result in an increase in tolerability challenges, suggesting that the deuterated structure of deupirfenidone may overcome the dose-limiting adverse events associated with pirfenidone. PureTech believes these PK results are consistent with the enhanced efficacy and favorable tolerability seen with deupirfenidone 825 mg TID in the trial. Deupirfenidone was well tolerated at both doses studied. Safety analyses included identification of the 16 most common treatment-emergent adverse events, defined as occurring in more than 5% of participants in at least one treatment group, and characterized the arm with the highest relative incidence of each of these 16 TEAEs.
The pirfenidone 801 mg treatment group had the highest relative incidence for 9 of these TEAEs, followed by deupirfenidone 825 mg (5), placebo (2), and deupirfenidone 550 mg. PureTech is targeting a meeting with the U.S. Food and Drug Administration by the end of the third quarter of 2025 to discuss the results of the Phase 2b trial and align on a potential registrational pathway, with the goal of initiating a Phase 3 trial by the end of 2025. PureTech anticipates providing further guidance later this year following the finalization of the trial design and FDA interactions.
