PureTech to Share Phase 2b ELEVATE IPF Trial Results of LYT-100 at ATS Conference

PureTech Health plc, a company at the forefront of biotherapeutics, shared groundbreaking findings related to idiopathic pulmonary fibrosis (IPF) at the American Thoracic Society International Conference in San Francisco, scheduled from May 16-21, 2025. This event marks a significant milestone as PureTech presents results from its Phase 2b ELEVATE IPF trial, showcasing the promising potential of deupirfenidone (LYT-100) in treating this severe lung condition.

The ELEVATE IPF trial focused on examining the impact of deupirfenidone, a novel therapy, on patients suffering from IPF, a debilitating disease characterized by irreversible lung scarring leading to severely impaired breathing. Traditionally, treatments for IPF have had limited success, with existing therapies only moderately slowing the disease's progression. In contrast, PureTech's deupirfenidone demonstrated a capacity to stabilize lung function over a period of 26 weeks. This finding is particularly significant as no current or investigational treatments have previously achieved such outcomes.

Bharatt Chowrira, CEO of PureTech, emphasized the breakthrough nature of these findings. He noted that the trial results not only highlight the efficacy of deupirfenidone as a standalone treatment but also underscore its safety and tolerability. This advancement could potentially redefine the standard of care for IPF, offering hope to many patients who suffer from this progressive and ultimately fatal disease.

Looking forward, PureTech plans to engage with the U.S. Food and Drug Administration (FDA) by the third quarter of 2025 to discuss the trial results and explore a pathway for registration. The company aims to kick off a Phase 3 trial by the end of 2025, contingent on successful regulatory discussions. Details regarding the trial design and further strategic guidance will be provided later in the year following interactions with the FDA.

The Phase 2b ELEVATE IPF trial was meticulously designed as a global, randomized, double-blind study, including active and placebo-controlled segments. This trial aimed to evaluate deupirfenidone against placebo and existing treatment, pirfenidone, across 257 participants. Participants were divided into groups receiving either 550 mg or 825 mg of deupirfenidone, 801 mg of pirfenidone, or a placebo, administered three times daily over 26 weeks. Those who completed the trial were given the opportunity to participate in an ongoing open-label extension.

A key focus of the trial was the decline rate in Forced Vital Capacity (FVC), a critical measure of lung function, with findings analyzed through a prespecified Bayesian approach. This analytical method provided robust efficacy data while minimizing the number of patients exposed to placebo, an ethical consideration given the progressive nature of IPF.

Deupirfenidone represents a deuterated version of pirfenidone, one of the two current FDA-approved treatments for IPF. The new formulation aims to enhance treatment efficacy by overcoming the limitations of current therapies, which often result in suboptimal dosing due to tolerability issues. By maintaining safety and efficacy over an extended period, deupirfenidone has the potential to significantly improve patient outcomes and possibly extend its benefits to other fibrotic diseases.

Idiopathic Pulmonary Fibrosis remains a challenging condition, affecting over 230,000 individuals in the U.S. and major European countries. Despite the availability of treatments, their use is limited, leaving a substantial unmet need for therapies that can offer more effective control over disease progression while ensuring patient adherence through improved tolerability.

PureTech's innovative approach and dedication to advancing biotherapeutics have resulted in a robust portfolio of therapeutic candidates, underscored by this promising development in IPF treatment. With the potential to set new benchmarks in care, deupirfenidone exemplifies PureTech's commitment to transforming the landscape for patients with devastating diseases.