Pliant Therapeutics Shares Bexotegrast Data at 2024 ERS Congress

Pliant Therapeutics, Inc., a late-stage biotechnology company specializing in novel treatments for fibrotic diseases, recently presented at the European Respiratory Society (ERS) International Congress 2024 in Vienna, Austria. The company shared important clinical and non-clinical data supporting the ongoing development of its lead therapeutic candidate, bexotegrast.

During the 2024 ERS Congress, several presentations highlighted the progress and potential of bexotegrast. Notably, Sydney B. Montesi, M.D., from Massachusetts General Hospital, presented findings from a Phase 2, single-center, randomized, double-blind, placebo-controlled trial (NCT05621252). This study utilized positron emission tomography (PET) imaging to evaluate type 1 collagen deposition in the lungs of patients with idiopathic pulmonary fibrosis (IPF). The results demonstrated that bexotegrast significantly reduced type 1 collagen after 12 weeks of treatment, in contrast to an increase observed in the placebo group. This reduction suggests bexotegrast’s antifibrotic effects and its potential to remodel lung tissue favorably. Additionally, improvements in forced vital capacity, cough severity, and prognostic biomarkers were observed, indicating the medication’s potential to modify IPF disease progression.

Moreover, bexotegrast showed enhanced results in dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), with increased peak enhancement and faster contrast washout rates. These findings point to improvements in lung microvasculature and decreased extravascular extracellular volume, reinforcing the PET imaging outcomes.

In another presentation, Gregory Cosgrove, M.D., Vice President of Clinical Development at Pliant Therapeutics, discussed the safety and tolerability of bexotegrast in Phase 2 trials for IPF and primary sclerosing cholangitis (PSC). The results from the INTEGRIS Phase 2a studies indicated that bexotegrast was well-tolerated over 12 weeks with no serious adverse events related to the treatment. Most adverse effects were mild to moderate, and the discontinuation rates were low in both trials.

Further supporting bexotegrast's antifibrotic potential, Johanna Schaub, Ph.D., presented a study involving precision cut-lung slices from patients with various fibrotic interstitial lung diseases (ILD). The study showed that bexotegrast decreased profibrogenic gene expression in lung slices from a broad spectrum of ILD patients, suggesting similar antifibrotic activity in both IPF and non-IPF lung tissues. These results advocate for continued exploration of bexotegrast in broader ILD-associated pulmonary fibrosis contexts.

Additionally, a post-hoc biomarker analysis was presented by Martin Decaris, Ph.D., involving plasma samples from the INTEGRIS-IPF Phase 2a trial. The analysis revealed that plasma levels of several biomarkers associated with ILD progression, including integrin beta-6, were reduced in participants treated with bexotegrast at a 320 mg dose compared to placebo. This decrease correlated with positive changes in lung function, measured by percent predicted forced vital capacity (FVCpp). These biomarker findings will be further explored in the ongoing global Phase 2b/3 BEACON-IPF trial.

Pliant Therapeutics continues to make significant strides in its mission to develop effective treatments for fibrotic diseases. The company's lead product, bexotegrast, has received Fast Track and Orphan Drug Designations from the U.S. FDA for IPF and PSC, as well as Orphan Drug Designation from the European Medicines Agency. Pliant Therapeutics is also conducting a Phase 1 study for PLN-101095, targeting solid tumors, and has regulatory clearance for a Phase 1 study of PLN-101325 for muscular dystrophies.

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