PureTech Health presents LYT-100 data at CHEST 2024

PureTech Health presented two oral presentations and one poster supporting its clinical and patient engagement strategies related to LYT-100 for the treatment of idiopathic pulmonary fibrosis, or IPF, at the CHEST 2024 Annual Meeting in Boston, Massachusetts. PureTech presented qualitative and quantitative research that highlights both the burden of IPF as well as gaps in disease management that exacerbate the quality of life for people with IPF. The 90-person survey found that the majority of participants experience a high burden of disease that interferes with their normal activities, including shortness of breath, fatigue and cough. In addition to the burden of the disease itself, comorbidities, side effects of antifibrotic treatment and the use of supplemental oxygen interfere with patients’ quality of life, suggesting a need for improved interventions to manage symptoms. Beyond this, PureTech’s research revealed commonalities and differences in the patient experience for those receiving care at interstitial lung disease, or ILD, centers versus community pulmonary practices. When asked about their top resources for IPF information, nearly all people in both care settings listed their pulmonologist as their primary source, and the majority in each were very satisfied with their communications about their IPF diagnosis. Antifibrotic treatment rates at ILD centers and CPPs were similar, but differences existed in perceived communication around antifibrotic treatment options. 76% of people receiving care in ILD centers reported that their pulmonologist had discussed both FDA-approved antifibrotics with them, while this was only true of 56% of those receiving care at CPPs. Across a series of quality-of-life parameters, patients at CPPs indicated a higher impact and severity of their disease than patients at ILD centers, reflecting an important discrepancy that merits further investigation. PureTech also presented a clinical abstract reviewing its plan to evaluate the primary outcome of the Phase 2b ELEVATE IPF clinical trial using a prespecified Bayesian approach. ELEVATE IPF is PureTech’s 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 for up to 26 weeks and have the option to enroll in an open-label extension. The primary endpoint is the rate of decline in Forced Vital Capacity for the combined LYT-100 arms versus placebo over the 26-week treatment period using a Bayesian linear mixed effects model including dynamic borrowing. This approach augments the placebo arm sample size with external placebo data from historical IPF trials. A Bayesian approach has the advantage of enhancing overall statistical power and improving decision-making while limiting the number of patients required to be treated with placebo in a fatal disease. This approach has been used previously in Phase 2 trials of novel IPF therapeutics. Topline results from the Phase 2b ELEVATE IPF trial are expected by the end of 2024. A streamlined development program for LYT-100 is planned using the same endpoints that have supported past IPF product approvals. Pending positive clinical outcomes and regulatory feedback, the program will advance into a Phase 3 clinical trial. PureTech believes the results of the Phase 2b trial, together with a successful Phase 3 trial, could serve as the basis for registration in the U.S. and other geographies.