PureTech Announces Completion of Enrollment in Phase 2b ELEVATE IPF Trial of LYT-100 (Deupirfenidone) in Idiopathic Pulmonary Fibrosis

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF).

LYT-100 is a deuterated form of pirfenidone, which is one of the two standard-of-care treatments, along with nintedanib, approved to treat IPF. Both pirfenidone and nintedanib are efficacious but associated with significant tolerability issues, contributing to approximately 75 percent of people with IPF in the U.S. choosing to forego treatment.¹ LYT-100 is designed to address this unmet need by retaining the beneficial pharmacology and clinically-validated efficacy of pirfenidone with a highly differentiated pharmacokinetic (PK) profile. This PK profile and the resulting favorable tolerability have been demonstrated across multiple clinical trials in more than 400 individuals.

“Despite the severity and progressive nature of IPF, there has been a dearth of successful therapeutic innovation since the approvals of pirfenidone and nintedanib nearly a decade ago,” said Toby Maher, M.D., Ph.D., Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles, and an investigator in the ELEVATE IPF trial. “LYT-100 builds on the established efficacy of pirfenidone, and data generated to date suggest it may address key tolerability issues that prevent patients from starting or continuing treatment. LYT-100 has the potential to have a profound impact on the way IPF is managed by allowing patients to start, continue and fully benefit from treatment, both as monotherapy and in combination settings with other antifibrotic therapies. This milestone in the ELEVATE IPF trial is very exciting, and I look forward to the full results as a potential step forward for the large, underserved IPF patient community.”

The Phase 2b ELEVATE IPF trial is a randomized, double-blind, placebo-controlled, dose-finding study designed to evaluate the efficacy, tolerability, safety and dosing regimen of LYT-100 in patients with IPF compared to placebo. The trial will also assess the relative efficacy of two doses of LYT-100. Participants have been randomized in a ratio of 1:1:1:1 to receive either 550 mg of LYT-100, 825 mg of LYT-100, pirfenidone or placebo three times a day (TID) for up to 26 weeks and includes an optional open-label extension. The primary endpoint is the rate of decline in Forced Vital Capacity (FVC) for the combined LYT-100 arms versus placebo over the 26-week treatment period using a prespecified Bayesian approach. Other key endpoints include tolerability measures, biomarkers and patient-reported outcomes. Both doses of LYT-100 will be compared to pirfenidone, though the trial is not powered to show a statistical difference in efficacy between LYT-100 and pirfenidone. Topline results are expected in the fourth quarter of 2024.