bexotegrast (PLN-74809) / Pliant Therapeutics - LARVOL DELTA

Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of PLN-74809 (ANZCTR) - P1 | N=80 | Completed | Sponsor: Pliant Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Hepatology • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Pliant Therapeutics Announces Upcoming Presentations at the 2025 American Thoracic Society International Conference (GlobeNewswire) - "Pliant Therapeutics, Inc...today announced that the Company will present three scientific posters at the upcoming 2025 American Thoracic Society (ATS) International Conference, taking place in San Francisco, California from May 16-21, 2025."

Clinical data • Fibrosis • Interstitial Lung Disease

Bexotegrast, an α V β 6 and α V β 1 Integrin Inhibitor, Is Associated With Dose-Dependent α V β 6 Target Engagement in the Lungs of Participants With Idiopathic Pulmonary Fibrosis (ATS 2025) - No abstract available

Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

BEACON-IPF, an Adaptive, Randomized, Placebo-Controlled, Global, Phase 2b/3 Study of Bexotegrast for Treatment of Idiopathic Pulmonary Fibrosis: Baseline Characteristics of Participants Enrolled to Date (ATS 2025) - No abstract available

Clinical • P2/3 data • P2b data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Dual αvβ6 and αvβ1 Inhibition Over 12 Weeks Reduces Active Type 1 Collagen Deposition in Individuals with Idiopathic Pulmonary Fibrosis: A Phase 2, Double-Blind, Placebo-controlled Clinical Trial. (PubMed, Am J Respir Crit Care Med) - P2 | "Bexotegrast treatment resulted in numerical improvements in FVC, cough severity, and biomarker levels. The reduced uptake of 68Ga-CBP8 in the lungs of participants with IPF indicates an antifibrotic effect of bexotegrast, suggesting the potential for favorable lung remodeling."

Clinical • Journal • P2 data • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Comparative Study With ING-006, Nintedanib, Nerandomilast and Bexotegrast Using the In Vivo CAM-Patient-Derived IPF Model (ATS 2025) - No abstract available

Preclinical • Idiopathic Pulmonary Fibrosis

Single-cell Profiling Demonstrates the Antifibrotic Effects of Bexotegrast on Pathologic Lung Cell Populations in the Presence and Absence of Background Therapy (ATS 2025) - No abstract available

Clinical • Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Characterizing the Antifibrotic Activity of Bexotegrast on Distinct Fibroblast Populations in PCLS From Multiple ILD Subtypes (ATS 2025) - No abstract available

Clinical • Interstitial Lung Disease

Pliant Therapeutics Provides Update on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "Pliant Therapeutics, Inc...today announced that following a prespecified data review and recommendation by the trial’s independent Data Safety Monitoring Board (DSMB), as well as a secondary review and recommendation by an outside expert panel, Pliant has discontinued the BEACON-IPF Phase 2b trial evaluating bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). While an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups led to the discontinuation of the trial, early evidence of efficacy on the forced vital capacity (FVC) endpoint was also observed."

Trial termination • Idiopathic Pulmonary Fibrosis

Pliant Therapeutics Provides Corporate Update and Reports Fourth Quarter 2024 Financial Results (GlobeNewswire) - "Research and development expenses were $38.8 million, as compared to $33.2 million for the prior-year quarter. The increase was primarily due to costs associated with the BEACON-IPF Phase 2b/3 clinical trial....Net loss was $49.7 million as compared to $41.1 million for the prior-year quarter. The increase was due to higher operating expenses primarily attributable to costs associated with the BEACON-IPF Phase 2b/3 clinical trial and reduced interest income on short-term investments."

Commercial • Idiopathic Pulmonary Fibrosis

Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=360 | Active, not recruiting | Sponsor: Pliant Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Pliant Therapeutics Announces Next Steps Following DSMB Recommendation on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "Pliant Therapeutics, Inc...the Company has initiated the assembly of an outside expert panel to review unblinded data from the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The panel, consisting of world-renowned experts in pulmonary diseases and biostatistics, will provide an independent recommendation to Pliant regarding the BEACON-IPF trial. Subsequently, the panel will serve as part of an expanded DSMB with the goal to reach a consensus recommendation regarding BEACON-IPF...Following the DSMB’s previously announced recommendation, Pliant voluntarily paused enrollment and dosing in the BEACON-IPF clinical trial. Pliant is committed to remaining blinded ensuring the data integrity of the BEACON-IPF 2b clinical trial with the goal of maintaining its potential to serve as a registrational trial."

DSMB • Genetic Disorders

Pliant Therapeutics Provides Update on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "Pliant Therapeutics...announced that following a prespecified data review and recommendations by the trial’s independent Data Safety Monitoring Board (DSMB), the Company has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). Patients currently enrolled in BEACON-IPF will remain in the trial. Enrollment and dosing have been paused while data is reviewed to understand the DSMB’s rationale for their recommendation. Blinding of the study will be maintained to preserve trial integrity. The Company has informed BEACON-IPF clinical trial investigators and is in the process of informing global regulatory authorities."

DSMB • Trial suspension • Idiopathic Pulmonary Fibrosis

Bexotegrast: Initiation of P3 trial for IPF in Q1 2025 (43rd Annual J.P. Morgan Healthcare Conference, Pliant Therap)

New P3 trial • Idiopathic Pulmonary Fibrosis

Bexotegrast: Initiation of P3 trial for IPF in Q1 2025 (43rd Annual J.P. Morgan Healthcare Conference, Pliant Therap)

New P3 trial • Idiopathic Pulmonary Fibrosis

Bexotegrast in people with idiopathic pulmonary fibrosis (IPF): a plain language summary of publication of the INTEGRIS-IPF study. (PubMed, Ther Adv Respir Dis) - "There is no cure for IPF, treatment includes symptom management and consideration for the use of nintedanib or pirfenidone, which may decrease the pace of disease progression.The study compared bexotegrast to a placebo (a treatment that looks identical to the medicine but has no medicinal effect) to look at how well it works and how safe it is in treating people with IPF. Most people in the study also took one of two medicines that are already approved by the FDA for IPF, pirfenidone or nintedanib."

Journal • Review • Critical care • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Bexotegrast Shows Dose-dependent Integrin αvβ6 Receptor Occupancy in Lungs of Participants with Idiopathic Pulmonary Fibrosis: A Phase 2, Open-Label Clinical Trial. (PubMed, Ann Am Thorac Soc) - P2 | " In this open-label, single-center, single-arm study, adults with IPF received up to 2 single doses of bexotegrast, ranging from 60 to 320 mg with or without background IPF therapy (pirfenidone or nintedanib). Trial registration number: NCT04072315 Primary source of funding: Pliant Therapeutics, Inc. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/)."

Journal • P2 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • TGFB1

Pliant Therapeutics INTEGRIS-PSC Phase 2a Data Evaluating Bexotegrast in Primary Sclerosing Cholangitis to be Highlighted in a Late-Breaking Presentation at The Liver Meeting 2024 (GlobeNewswire) - "Pliant Therapeutics, Inc...today announced a late-breaking presentation of results from the INTEGRIS-PSC Phase 2a trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) at The Liver Meeting 2024 of the American Association for the Study of Liver Diseases (AASLD), in San Diego, California November 15 – 19."

P2a data • Hepatology • Immunology

Post-hoc biomarker analysis in participants with IPF receiving bexotegrast over 12-weeks in INTEGRIS-IPF (ERS 2024) - P2 | "Conclusions Thirteen candidate biomarkers of early therapeutic response were identified in participants with IPF receiving bexotegrast. Further biomarker analyses are planned in the enrolling Phase 2b BEACON-IPF study (NCT06097260)."

Biomarker • Retrospective data • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • ITGB6 • MMP10 • SPON1 • TGFB1

Late Breaking Abstract - Evaluation of the antifibrotic activity of bexotegrast, a dual αVβ6/αVβ1 integrin inhibitor, in precision-cut lung slices prepared from non-IPF interstitial lung disease explants (ERS 2024) - "Inhibition of integrins αVβ6 and αVβ1 with bexotegrast reduced pro-fibrotic gene expression in human PCLS prepared from patients with non-IPF ILDs. These data support further investigation of the antifibrotic activity of bexotegrast in ILD associated PPF."

Late-breaking abstract • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis • COL1A1 • COL1A2 • SERPINE1 • TGFB1

Safety and tolerability of bexotegrast in Phase 2 trials of idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) (ERS 2024) - P2 | "Most diarrhea events were mild or moderate and occurred in participants with IPF treated with BEXO and nintedanib, which is associated with diarrhea. Bexotegrast was generally well tolerated in Phase 2 trials ≥12 weeks, with no related SAEs. Most AEs were mild to moderate, and discontinuation rates were low. Late-stage evaluation is currently underway in the BEACON-IPF study (NCT06097260)."

Clinical • P2 data • Fatigue • Hepatology • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Novel Coronavirus Disease • Pain • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Bexotegrast reduces type 1 collagen deposition in participants with idiopathic pulmonary fibrosis (IPF) after 12 weeks of therapy (ERS 2024) - P2 | "68Ga-CBP8 PET detected clear antifibrotic effects and potential lung remodeling with BEXO. BEXO improved FVC, biomarkers of fibrosis, and cough severity, suggesting its potential for disease modification."

Late-breaking abstract • Cough • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • ITGB6

Post-hoc biomarker analysis in participants with IPF receiving bexotegrast over 12-weeks in INTEGRIS-IPF (GlobeNewswire) - "In a poster presentation, Martin Decaris, Ph.D., Senior Director, Translational Sciences at Pliant Therapeutics, presented results from a post-hoc proteomic analysis of plasma samples from the INTEGRIS-IPF Phase 2a clinical trial of bexotegrast in patients with IPF. Results showed that plasma levels of several previously identified biomarkers of ILD progression, including integrin beta-6, were reduced in participants receiving bexotegrast at the 320 mg dose versus placebo. Plasma integrin beta-6 levels were also found to negatively correlate with changes in lung function as determined by percent predicted forced vital capacity (FVCpp)."

Retrospective data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease

Safety and tolerability of bexotegrast in Phase 2 trials of idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) (GlobeNewswire) - P2 | N=120 | INTEGRIS-IPF (NCT04396756) | P2 | N=121 | INTEGRIS-PSC (NCT04480840) | Sponsor: Pliant Therapeutics, Inc. | "In an oral presentation, Gregory Cosgrove, M.D. FCCP, Vice President of Clinical Development at Pliant Therapeutics presented an integrated safety summary of bexotegrast from the INTEGRIS Phase 2a trials in IPF and primary sclerosing cholangitis (PSC). Results showed that, at 12 weeks of treatment, bexotegrast was well tolerated with no related serious adverse events with most adverse events being mild to moderate with low discontinuation rates across both trials."

P2a data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease

Bexotegrast reduces type 1 collagen deposition in participants with idiopathic pulmonary fibrosis (IPF) after 12 weeks of therapy (GlobeNewswire) - P2 | N=10 | NCT05621252 | Sponsor: Pliant Therapeutics, Inc. | "Following 12 weeks of treatment, bexotegrast demonstrated a reduction in type 1 collagen in contrast to an increase on placebo, supporting bexotegrast’s antifibrotic effects and suggesting favorable lung remodeling. In addition, treatment with bexotegrast showed numerical improvements in forced vital capacity, cough severity, and prognostic biomarkers, suggesting its potential for disease modification in idiopathic pulmonary fibrosis (IPF). Lastly, measurements by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), bexotegrast demonstrated an increased peak enhancement and a faster contrast washout rate, suggesting improvements in lung microvasculature and decreased extravascular extracellular volume, further supporting the PET imaging findings."

P2a data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease