Pliant Therapeutics has halted the development of bexotegrast for idiopathic pulmonary fibrosis (IPF) after a Phase 2b/3 trial, BEACON-IPF, revealed an unfavorable risk-benefit profile. The trial was stopped early due to an imbalance in IPF-related adverse events in patients receiving bexotegrast compared to placebo. Analysis of the full data confirmed increased risks of disease progression, respiratory-related hospitalization, and mortality in the treatment group, despite some observed improvements in forced vital capacity (FVC) decline at certain time points.
This discontinuation represents a setback for Pliant and for IPF patients seeking new therapies. While bexotegrast showed initial promise in earlier trials, the BEACON-IPF results highlight the challenges in developing effective and safe treatments for this complex disease. The findings also underscore the importance of rigorous clinical trials and safety monitoring in drug development. This news may lead to increased scrutiny of integrin-targeting therapies for IPF and similar fibrotic conditions.
The BEACON-IPF trial tested bexotegrast at 160 mg and 320 mg doses. At 12 weeks, the 160 mg group showed a statistically significant 72 mL improvement in FVC decline compared to placebo, while the 320 mg group showed a non-significant 46 mL improvement. However, by week 24, neither dose showed statistically significant benefit. The average time to disease progression in bexotegrast-treated patients was 33 weeks, suggesting the safety risks emerge over longer durations. Meanwhile, Pliant continues its Phase 1 trial of PLN-101095, a dual αvβ8 and αvβ1 integrin inhibitor, for solid tumors, and maintains its early-stage research programs focused on integrin-based drug delivery.
Pliant is now shifting its focus to its oncology and early-stage programs. While the discontinuation of bexotegrast for IPF represents a significant loss, the company’s diverse pipeline and drug discovery platform still hold potential. The continued development of PLN-101095 for oncology applications will be critical to demonstrate the therapeutic value of integrin modulation in other disease areas. The company’s future success likely hinges on learnings from the BEACON-IPF trial and strategic allocation of resources to its remaining programs.
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.
