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

PureTech has previously shared data from a crossover trial showing that a 550 mg dose of LYT-100 provided bioequivalent drug exposure to the FDA-approved dose of pirfenidone, 801 mg. This dose also achieved an approximately 50 percent reduction in participants experiencing gastro-intestinal (GI) and central nervous system (CNS)-related adverse events (AEs) compared to those taking pirfenidone. Additionally, the data showed that a higher dose of LYT-100 (824 mg TID), which achieved a 43 percent higher drug exposure level, was well-tolerated with no additional incidence of GI or CNS AEs when titrated up from LYT-100 550 mg TID. These results reinforce the potential for LYT-100 to provide enhanced efficacy with favorable tolerability in IPF. This hypothesis is supported by Phase 3 data with pirfenidone that showed a dose-response effect on forced vital capacity and survival in people with IPF.² PureTech is therefore investigating the efficacy and tolerability of LYT-100 at 550 mg TID and 825 mg TID in the Phase 2b ELEVATE IPF trial.

PureTech plans to pursue a streamlined development program for LYT-100 in IPF and is using the same validated endpoints that have supported past antifibrotic approvals. PureTech believes the results of the Phase 2b trial, together with an additional Phase 3 trial, could serve as the basis for registration in the U.S. and other geographies.

PureTech would like to extend its gratitude to those participating in the ELEVATE IPF trial, especially the people living with IPF and their caregivers, the clinical trial sites, investigators and advocacy groups.

About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a rare, progressive and fatal lung disease with a median survival of 2-5 years.³ Pirfenidone is one of only two drugs approved to treat IPF, and for those patients able to tolerate treatment, it has been shown to improve survival by approximately 2.5 years compared to supportive care alone.³ However, tolerability issues with both of the standard-of-care drugs result in patients discontinuing treatment or reducing their dose. This contributes to nearly three out of every four people with IPF choosing to forego treatment with these otherwise efficacious medicines.¹