The experts will assess unblinded data from BEACON-IPF to figure out why a data safety monitoring board recommended suspension of the idiopathic pulmonary fibrosis trial.
Pliant Therapeutics will assemble an external panel of experts to review data from the ongoing Phase IIb BEACON-IPF trial of its investigational integrin inhibitor bexotegrast in idiopathic pulmonary fibrosis, the biotech announced on Thursday.
The move comes after an independent data safety monitoring board (DSMB) last week recommended that the study be put on hold—something that Pliant “has not been able, through review of blinded data, to determine the rationale for,” according to Thursday’s press announcement. The biotech expects the outside review to finish in two to four weeks.
To review the DSMB’s recommendations, Pliant will bring together what it described as “world-renowned experts in pulmonary diseases and biostatistics” to examine BEACON-IPF’s unblinded data and give the company their independent assessment of the findings.
Following the outside review, the panelists will act as an “expanded” DSMB and work with the existing monitors to “reach a consensus recommendation” regarding the path forward for BEACON-IPF, according to Pliant’s announcement.
Pliant’s shares rose 28% on Thursday following its announcement, according to Seeking Alpha, giving the biotech some breathing room after its 58% stock crash following the trial pause announcement last week.
Bexotegrast is a small-molecule drug candidate that works by targeting and blocking the αvβ6 and αvβ1 integrins, which are typically overexpressed in fibrotic tissue. Bexotegrast thus prevents the formation and growth of scar tissue—a hallmark of idiopathic pulmonary fibrosis.
Phase IIa data released in May 2024 reveal a strong reduction in lung collagen levels after bexotegrast treatment, whereas placebo counterparts saw an increase in the protein. Excessive collagen deposits in the lungs are a hallmark of idiopathic pulmonary fibrosis.
Bexotegrast also boosted lung function and lowered cough severity versus placebo. At the time, Pliant said that these findings point to the “potential reversal of fibrosis” with bexotegrast.
Lung fibrosis is a popular target for biopharma and is shaping up to be a competitive field, with several clinical successes and high-ticket deals in the past year.
Just last week, for instance, Boehringer Ingelheim revealed a Phase III win for nerandomilast, which significantly improved lung function versus placebo in patients with progressive pulmonary fibrosis. Six months earlier, Boehringer reported similar lung function improvements with nerandomilast in idiopathic pulmonary fibrosis.
And last month, Eli Lilly signed a potential $780 million global partnership with Mediar Therapeutics to advance a first-in-class therapy for idiopathic pulmonary fibrosis.
