Pliant Therapeutics Pauses Phase IIb IPF Trial, Seeks Expert Review

Pliant Therapeutics, a biotechnology company focused on developing treatments for fibrotic diseases, has announced a temporary suspension of its Phase IIb BEACON-IPF trial for bexotegrast, an investigational integrin inhibitor targeting idiopathic pulmonary fibrosis (IPF). The decision comes following a recommendation from an independent data safety monitoring board (DSMB), prompting the company to seek additional expert review.

Trial Suspension and Expert Panel

Last week, the DSMB recommended that the BEACON-IPF study be put on hold. In response, Pliant Therapeutics has decided to assemble an external panel of experts to review unblinded data from the trial. The company stated that it has been unable to determine the rationale for the DSMB's recommendation through its review of blinded data.

The external panel, described as "world-renowned experts in pulmonary diseases and biostatistics," will examine the unblinded data and provide an independent assessment of the findings. This review process is expected to take two to four weeks to complete.

Following the review, the panelists will function as an "expanded" DSMB, working alongside the existing monitors to reach a consensus recommendation on the future direction of the BEACON-IPF trial.

Bexotegrast and IPF Treatment Landscape

Bexotegrast is a small-molecule drug candidate designed to target and block the αvβ6 and αvβ1 integrins, which are typically overexpressed in fibrotic tissue. By inhibiting these integrins, bexotegrast aims to prevent the formation and growth of scar tissue, a hallmark of idiopathic pulmonary fibrosis.

Previous Phase IIa data released in May 2024 showed promising results for bexotegrast, including a strong reduction in lung collagen levels, improved lung function, and decreased cough severity compared to placebo. These findings suggested the potential for fibrosis reversal with bexotegrast treatment.

The field of lung fibrosis treatment has become increasingly competitive, with several recent clinical successes and high-profile deals. For instance, Boehringer Ingelheim recently reported positive Phase III results for nerandomilast in progressive pulmonary fibrosis, demonstrating significant improvements in lung function compared to placebo. Additionally, Eli Lilly entered into a potential $780 million global partnership with Mediar Therapeutics last month to advance a first-in-class therapy for idiopathic pulmonary fibrosis.