PLRX

First participant dosed in FORTIFY, a Phase 1b indication expansion trial of PLN-101095 Oral presentation at AACR 2026 featured updated data from Phase 1 trial of PLN-101095 showing deepening of confirmed responses in checkpoint inhibitor-refractory solid tumors PLN-101095 spotlighted as novel IO approach as part of AACR's 2026 Highlights Plenary Session SOUTH SAN FRANCISCO, Calif., May 11, 2026 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, today provided a corporate update and reported first quarter 2026 financial results. “In the first quarter, our team showcased its clinical development capabilities, initiating FORTIFY, the Phase 1b trial of PLN-101095, ahead of schedule and dosing the first patient in April,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “We were excited to highlight encouraging recent data from the Phase 1a trial of PLN-101095 at AACR showing deepening responses and increasing time on treatment. The team continues to make progress on pipeline programs emerging from Pliant's proprietary integrin platform while evaluating opportunities to expand our clinical-stage pipeline.” Oncology Program PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. Pliant is currently conducting a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT0670706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, as monotherapy and in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. FORTIFY, a Phase 1b indication expansion trial, enrolling and dosing patients. In April, the Company announced the dosing of its first participant in the FORTIFY Phase 1b indication expansion trial. The Phase 1b open-label, single dose trial will enroll three cohorts of patients including non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma and a subset of tumors with high tumor mutational burden. Tumor selection was based on data from the Phase 1 trial, as well as strong mechanistic rationale for integr...

PLN-101095 Phase 1 data showed deep and durable ongoing responses in checkpoint inhibitor refractory solid tumors PLN-101095 accelerated development plan underway with initiation of Phase 1b indication expansion trial SOUTH SAN FRANCISCO, Calif., March 11, 2026 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, today provided a corporate update and reported fourth quarter 2025 financial results. “We ended 2025 with encouraging data from our lead oncology program in ICI-refractory patients, an area of unmet medical need, that informed the initiation of our accelerated development plan for PLN-101095,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “In addition to oncology and the early-stage pipeline programs emerging from Pliant's proprietary integrin platform, we continue to assess opportunities to expand our clinical-stage pipeline that leverage our areas of expertise and align with creating shareholder value.” Fourth Quarter and Recent Developments Oncology Program PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. Pliant is currently conducting a Phase 1a/1b open-label, dose-escalation and indication expansion trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, as monotherapy and in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. Data from the Phase 1 trial of PLN-101095 showed deep and durable ongoing responses. In December, the Company announced positive data showing that, in a heavily pretreated patient population, PLN-101095 demonstrated anti-tumor activity in combination with pembrolizumab, an FDA-approved ICI. Four responders were observed consisting of one confirmed complete response and three partial responses (two confirmed, one unconfirmed) out of the 10 secondary ICI refractory patients. These clinical responses were observed in patients with cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma and non-small cell lung cancer (NSCLC). Notably, all responding patients showed large i...

Oncology program advancing with data expected in the fourth quarter 2025 BEACON-IPF close out activities to be completed in the fourth quarter 2025 SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, today provided a corporate update and reported third quarter 2025 financial results. “During the third quarter, our team continued to advance our portfolio while winding down activities surrounding the BEACON-IPF trial,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “Looking ahead, we continue to evaluate a range of opportunities to create shareholder value.” Third Quarter and Recent Developments Oncology Program Phase 1 open-label trial of PLN-101095 in solid tumors has completed enrollment. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. The Phase 1 open-label, dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab is in patients with solid tumors that are resistant to immune checkpoint inhibitors. In March of 2025 we announced interim data from this trial showing PLN-101095 was well tolerated and displayed an objective response rate of 50% in the third of five ascending dose cohorts. The trial has now completed enrollment of all five dose cohorts. Data from the trial, including the two highest dose cohorts, is expected by the end of 2025. Bexotegrast BEACON-IPF close out activities to be completed in fourth quarter. Close out activities from the BEACON-IPF Phase 2b/3 clinical trial are expected to be completed in the fourth quarter of 2025 with full results from the trial to be submitted for future publication. Corporate Highlights In October, the Company announced that it completed a voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the March 11, 2024 Loan Agreement with Oxford Finance LLC. Third Quarter 2025 Financial Results Research and development expenses were $17.9 million as compared to $47.8 million for the prior-year quarter. The decrease was primarily driven by the discontinuation of BEACON-IPF. General and admini...

BEACON-IPF close out activities continue Previously announced workforce and operational realignment largely complete Phase 1 oncology trial on track to deliver additional data by the end of the year SOUTH SAN FRANCISCO, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in integrin-based drug development, today provided a corporate update and reported second quarter 2025 financial results. “While our activities in the quarter focused on the closure of BEACON-IPF and workforce realignment, we also took actions to ensure that we maintain core capabilities in support of Pliant’s next steps,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “At the center is a deeply experienced late-stage clinical and regulatory development organization positioned to execute advanced trials. We remain committed to delivering shareholder value and look forward to providing updates in the future.” Second Quarter and Recent Developments Bexotegrast Bexotegrast development in idiopathic pulmonary fibrosis (IPF) discontinued. Following an analysis of the full safety and efficacy data from the BEACON-IPF Phase 2b/3 clinical trial, the Company has discontinued development of bexotegrast in idiopathic pulmonary fibrosis (IPF). While bexotegrast-treated patients demonstrated early signs of efficacy, the drug was shown to have an unfavorable risk-benefit profile based on IPF-related adverse events. Full results from BEACON-IPF will be submitted for future publication. Oncology Program Phase 1 trial of PLN-101095 in solid tumors continues to enroll. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. The Phase 1 open-label, dose-escalation trial of PLN-101095 trial as monotherapy and in combination with pembrolizumab is in patients with solid tumors that are resistant to immune checkpoint inhibitors. The trial is currently dosing the fifth of five planned dose cohorts, evaluating PLN-101095 at 2000 mg administered twice daily (BID). Initial data from the two highest dose cohorts of the trial is expected by the end of 2025. Corporate Highlights In May, the Company announced a strategic restructuring of its workforce and other cost-saving measures intended to extend its ca...

Pliant Therapeutics has discontinued the bexotegrast development for idiopathic pulmonary fibrosis (IPF) following a review of data from the terminated global, double-blind, randomised, placebo-controlled BEACON-IPF Phase IIb/III trial. The decision was influenced by the trial's full efficacy and safety data analysis involving 160mg and 320mg doses of the therapy, which indicated an unfavourable risk-benefit profile. In March 2025, the company announced the voluntary discontinuation of the BEACON-IPF based on recommendations and prespecified data review by the independent Data Safety Monitoring Board (DSMB) and an external expert panel, which noted an imbalance in IPF-related adverse events among participants. The therapy led to an increased risk of adverse events related to the progression of IPF disease against placebo. These included worsening of IPF, acute exacerbation, all-cause death, and respiratory-related hospitalisation. Subjects treated by the therapy had an average time to disease progression of 33 weeks. However, at week 12, the 160mg and 320mg therapy groups showed improvements in forced vital capacity (FVC) decline of 72mL and 46mL, respectively against placebo. At week 24, the improvements in FVC decline were observed as 58mL and 8mL for 160mg and 320mg groups, respectively. Pliant plans to submit the full outcomes from the BEACON-IPF trial for future publication. Pliant Therapeutics CEO and president Bernard Coulie said: "Although the decision to discontinue bexotegrast in IPF is disappointing for us and the many patients in need of new treatment options, we believe it is the right decision to protect patient safety. “We sincerely thank all patients, their caregivers, the study investigators and their research teams who were part of the BEACON-IPF clinical programme for their extensive efforts.” Meanwhile, the company continues to advance a Phase I open-label trial assessing PLN-101095, an oral small molecule inhibitor, as a single agent in solid tumours resistant to immune checkpoint inhibitors. The company’s early-stage platform encompasses preclinical research on tissue-specific delivery and internalisation of drug payloads leveraging integrin receptor-binding molecules. "Pliant halts bexotegrast development for IPF after trial results" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The informatio...

Activities supporting the close out of BEACON-IPF continue; topline data expected in the second quarter of 2025 Recently announced strategic realignment of workforce and operations will extend cash runway to support execution of late-stage clinical trials SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today provided a corporate update and reported first quarter 2025 financial results. “During the first quarter and over recent weeks, our teams have been working diligently to close out the global BEACON-IPF trial with the goal of announcing topline data in the second quarter,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “Additionally, progress was made in our oncology program with initial data from our Phase 1 dose escalation trial of PLN-101095 demonstrating antitumor activity, including confirmed partial responses, in a variety of solid tumors.” First Quarter and Recent Developments Bexotegrast Highlights BEACON-IPF close-out activities continue with topline data expected in the second quarter of 2025. Following the termination of the BEACON-IPF Phase 2b/3 trial evaluating bexotegrast in patients with idiopathic pulmonary fibrosis (IPF), the Company continues the formal close out of the global trial. Topline data from the BEACON-IPF trial is expected in the second quarter of 2025. Results from a Phase 2a positron emission tomography (PET) imaging trial published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The publication reviews the previously reported positive results from the first interventional, single-center double-blind, placebo-controlled Phase 2 trial of bexotegrast using PET and magnetic resonance imaging to evaluate collagen deposition in the lungs of 10 patients with IPF. Oncology Program Interim Phase 1 data from a trial of PLN-101095 and pembrolizumab demonstrated antitumor activity with confirmed partial responses in three of six patients treated with the highest dose tested to date. Topline data from the first three cohorts of the ongoing Phase 1 dose escalation trial of PLN-101095 in combination with pembrolizumab showed confirmed partial responses in solid tumors that are r...