Pliant Therapeutics has convened an external expert panel to analyze data from its paused BEACON-IPF Phase 2b trial of bexotegrast for idiopathic pulmonary fibrosis (IPF). This panel, comprised of pulmonary disease and biostatistics experts, will offer an independent recommendation on the trial’s future, eventually integrating into an expanded Data Safety Monitoring Board (DSMB). The decision to assemble the panel stems from Pliant’s inability to discern the reasoning behind the DSMB’s initial recommendation to halt trial enrollment and dosing based on the blinded data.
This situation holds significant implications for IPF patients. Bexotegrast represents a potential new treatment avenue for this debilitating lung disease, and the trial’s pause creates uncertainty regarding its development timeline and ultimate efficacy. A clear understanding of the DSMB’s concerns, provided through the expert panel’s analysis, is crucial for determining if and how the trial can proceed, directly impacting patients’ access to a potential new therapy. The outcome of this review will also influence investor confidence in Pliant and its pipeline.
The expert panel review is expected to conclude within two to four weeks. Pliant remains blinded to the trial data to preserve its integrity and potential for registration. This suggests that the company believes the trial, if restarted, could still serve as the basis for regulatory approval of bexotegrast.
This situation’s resolution will be a pivotal moment for Pliant. A positive recommendation from the expert panel could lead to the trial’s resumption, potentially salvaging bexotegrast’s development timeline. However, a negative outcome could necessitate significant trial modifications or even its termination, dealing a substantial blow to Pliant’s lead program. The expert panel’s findings will ultimately determine the future trajectory of bexotegrast and significantly impact the IPF treatment landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
