TGF-β inhibitors(Transforming growth factor beta inhibitors), αvβ1 inhibitors(Integrin alpha-V/beta-1 inhibitors), αvβ6 antagonists(Integrin alpha-V/beta-6 antagonists)

Therapeutic Areas

Respiratory DiseasesOther DiseasesInfectious Diseases+ [1]

Active Indication-

Inactive Indication

Cholangitis, SclerosingCOVID-19Fibrosis, Liver+ [3]

Originator Organization

Pliant Therapeutics, Inc.

Active Organization-

Inactive Organization

Pliant Therapeutics, Inc.

License Organization-

Drug Highest PhaseDiscontinuedPhase 2/3

First Approval Date-

RegulationOrphan Drug (United States), Orphan Drug (European Union), Fast Track (United States)

Structure/Sequence

Molecular FormulaC27H36N6O3

InChIKeyCWOFQJBATWQSHL-DEOSSOPVSA-N

CAS Registry2376257-44-0

Clinical Trials associated with Bexotegrast

NCT06097260

/ TerminatedPhase 2

A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy and Safety of Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosis (BEACON-IPF)

A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).

Start Date16 Nov 2023

Sponsor / Collaborator

Pliant Therapeutics, Inc.

NCT05621252

/ CompletedPhase 2

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Evaluation of PLN-74809 on Type 1 Collagen Deposition Using 68Ga-CBP8 PET/MRI Imaging in Participants With Idiopathic Pulmonary Fibrosis (IPF)

This is a Phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks. This study is occurring at Massachusetts General Hospital.

Start Date13 Jul 2022

Sponsor / Collaborator

Pliant Therapeutics, Inc.

NCT04565249

/ TerminatedPhase 2

A Randomized, Double-blind, Dose-ranging, Placebo Controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19 (INTEGRIS-ARDS)

Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19

Start Date22 Oct 2020

Sponsor / Collaborator

Pliant Therapeutics, Inc.

100 Clinical Results associated with Bexotegrast

100 Translational Medicine associated with Bexotegrast

100 Patents (Medical) associated with Bexotegrast

Literatures (Medical) associated with Bexotegrast

01 Jan 2026·JOURNAL OF HEPATOLOGY

Phase II INTEGRIS-PSC trial of bexotegrast, an αvβ6/αvβ1 integrin inhibitor, in primary sclerosing cholangitis

Article

Author: Clark, Annie ; Kowdley, Kris V ; Barnes, Chris N ; Orman, Eric ; Hameed, Bilal ; Pencek, Richard ; Levy, Cynthia ; Bowlus, Christopher L ; Lefebvre, Éric A ; Hirschfield, Gideon M ; Vincent, Catherine ; An, Mahru C ; Thorburn, Douglas ; Trauner, Michael ; Joshi, Deepak ; Eksteen, Bertus ; Chen, Tianyan ; Reddy, K Gautham ; Montano-Loza, Aldo J ; Schramm, Christoph ; Schaub, Johanna R ; Trivedi, Palak J ; Goel, Aparna

BACKGROUND & AIMS:

Transforming growth factor-β signaling activated by α_vβ₆ and α_vβ₁ integrins drives liver fibrosis in primary sclerosing cholangitis (PSC). The aim of this study was to investigate the safety and exploratory pharmacodynamics of bexotegrast (PLN-74809), an oral, once-daily inhibitor of α_vβ₆ and α_vβ₁ integrins, in participants with PSC and liver fibrosis.

METHODS:

In this phase II, double-blind, dose-ranging study, 117 participants with PSC were randomized 3:1 to receive once-daily oral bexotegrast or placebo in three cohorts: 40 mg or placebo for 12 weeks (part 1); 80 mg, 160 mg, or placebo for 12 weeks (part 2); and 320 mg or placebo for up to 40 weeks (part 3). The primary endpoint was the incidence of treatment-emergent adverse events (TEAEs). Exploratory pharmacodynamic endpoints included changes in alkaline phosphatase values, enhanced liver fibrosis (ELF) scores, neoepitope-specific N-terminal pro-peptide of type III collagen (PRO-C3) levels, liver stiffness measurements, gadoxetate-enhanced MRI measures, and the Itch Numeric Rating Scale.

RESULTS:

A total of 117 participants received bexotegrast (40 mg [n = 22], 80 mg [n = 21], 160 mg [n = 21], 320 mg [n = 27]) or placebo (n = 30). Bexotegrast was well tolerated, with similar rates of TEAEs in the pooled bexotegrast and placebo groups (72.7% and 70.0%). TEAEs were mild to moderate, and no serious TEAEs related to study drug were observed. Numerically less pharmacodynamic progression was observed with bexotegrast in ELF score, PRO-C3, and MRI assessments at Week 12 compared with placebo. Pharmacodynamic results at Week 24 showed limited change from Week 12 except in MRI parameters which continued to improve.

CONCLUSIONS:

Bexotegrast was well tolerated for up to 40 weeks in participants with PSC and liver fibrosis and was associated with numerically less progression in exploratory pharmacodynamic markers.

IMPACT AND IMPLICATIONS:

Primary sclerosing cholangitis (PSC) is a rare cholestatic disease of unknown etiology. Currently, there is an unmet medical need for safe and effective therapies capable of halting or reversing progression of PSC. In this phase II study in participants with PSC and suspected liver fibrosis, bexotegrast, an oral, once-daily, dual selective inhibitor of α_vβ₆ and α_vβ₁ integrins, had a favorable safety and tolerability profile. This study supports targeting integrin-mediated transforming growth factor-β activation as a potential therapeutic approach for PSC.

TRIAL REGISTRATION NUMBER:

NCT04480840.

01 Jul 2025·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Dual α _v β ₆ and α _v β ₁ Inhibition over 12 Weeks Reduces Active Type I Collagen Deposition in Individuals with Idiopathic Pulmonary Fibrosis: A Phase 2, Double-Blind, Placebo-controlled Clinical Trial

Article

Author: Zhou, Iris Y. ; Susnjar, Antonia ; Efthimiou, Nikos ; Barnes, Chris N. ; Catana, Ciprian ; Decaris, Martin ; Fromson, Caroline ; Montesi, Sydney B. ; Clark, Annie ; Turner, Scott M. ; Lefebvre, Éric A. ; Cosgrove, Gregory P. ; Caravan, Peter

Rationale: Idiopathic pulmonary fibrosis (IPF) is characterized by excessive deposition of type I collagen. ⁶⁸Ga-CBP8, a type I collagen positron emission tomography probe, measures collagen accumulation and shows higher collagen deposition in patients with IPF. Bexotegrast (PLN-74809) is an oral, once-daily, dual-selective inhibitor of α_vβ₆ and α_vβ₁ integrins under late-stage evaluation for treatment of IPF. Objectives: To evaluate changes in type I collagen in the lungs of participants with IPF after treatment with bexotegrast. Methods: In this phase 2 (NCT05621252), single-center, double-blind, placebo-controlled study, adults with IPF received bexotegrast 160 mg or placebo for 12 weeks. The primary endpoint was the change in whole-lung standardized uptake value of ⁶⁸Ga-CBP8 positron emission tomography. Changes in lung dynamic contrast-enhanced magnetic resonance imaging parameters, FVC, cough severity, and biomarkers of collagen synthesis and progressive disease were also assessed. Measurements and Main Results: Of 10 participants, 7 received bexotegrast and 3 received placebo. At Week 12, the mean change from baseline in the top quartile of ⁶⁸Ga-CBP8 whole-lung standardized uptake value was -1.2% with bexotegrast versus 6.6% with placebo; the greatest mean changes were observed in subpleural lung regions in both groups (bexotegrast, -3.7%; placebo, 10.3%). Dynamic contrast-enhanced magnetic resonance imaging showed numerically increased peak enhancement and faster contrast washout rate in bexotegrast-treated participants, suggesting improvements in lung microvasculature and decreased extravascular extracellular volume. Bexotegrast treatment resulted in numerical improvements in FVC, cough severity, and biomarkers. Conclusions: 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 trial registered with www.clinicaltrials.gov (NCT05621252).

25 Apr 2025·ANGEWANDTE CHEMIE-INTERNATIONAL EDITION

GOAT: A Global Optimization Algorithm for Molecules and Atomic Clusters

Article

Author: de Souza, Bernardo

Abstract:

In this work, we propose a new Global Optimization Algorithm (GOAT) for molecules and clusters of atoms and show how it can find the global energy minima for both systems without resorting to molecular dynamics (MD). This avoids the potential millions of time‐consuming gradient calculations required by a long MD run. Because of that, it can be used with any regular quantum chemical method, even with the costlier hybrid DFT. We showcase its accuracy by running it on various systems, from organic molecules to water clusters, metal complexes, and metal nanoparticles, comparing it with state‐of‐the‐art methods such as the Conformer‐Rotamer Ensemble Sampling Tool (CREST). We also discuss its underlying theory and mechanisms for succeeding in challenging cases. GOAT is, in general, more efficient and accurate than previous algorithms in finding global minima and succeeds in cases where others cannot due to the free choice for the Potential Energy Surface (PES).

140

News (Medical) associated with Bexotegrast

12 Mar 2026

·www.biospace.com

Pliant Therapeutics Provides Corporate Update and Reports Fourth Quarter 2025 Financial Results

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 increases in plasma interferon gamma (IFN-γ) after 14 days of monotherapy with PLN-101095 prior to the addition of pembrolizumab . No non-responders showed meaningful increases in plasma IFN- γ. PLN-101095 was generally well tolerated across all doses tested. IFN-γ is known to play a multifaceted role in modulating anti-tumor immunity, with increased tumor expression levels having previously been linked with better outcomes from immune checkpoint blockade. Accelerated development plan of PLN-101095 underway with initiation of Phase 1b indication expansion trial. Based on the encouraging response data and supportive IFN- γ biomarker data from the Phase 1 trial, the Company is advancing an accelerated clinical development plan of PLN-101095 and has initiated a Phase 1b indication expansion trial. The Phase 1b open-label, single dose trial will enroll three cohorts of patients including NSCLC, clear cell renal cell carcinoma and tumors with high tumor mutational burden. Tumor selection was based on data from the Phase 1 trial, as well as strong mechanistic rationale for integrin inhibition. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy. Study start activities for this trial are underway with first patient enrollment anticipated in second quarter. Interim data is expected in 2027. PLN-101095 Phase 1 data accepted for presentation at AACR Annual Meeting 2026. Data from the Phase 1 trial of PLN-101095 will be the subject of a poster presentation and an oral presentation as part of the Clinical Trials Minisymposium at the upcoming American Association of Cancer Research (AACR) conference to be held April 17-22, 2026, in San Diego, California. Integrin-Targeted Delivery Platform Utilizing cell-specific integrin receptors, Pliant has developed a platform to deliver drug payloads, including siRNAs, to selective tissue types. Current programs are focused on delivering siRNAs to skeletal muscle cells and other tissues. The Company believes this integrin-targeting delivery platform has the potential for broad applicability across multiple disease areas utilizing a variety of drug payloads. Corporate Highlights Appointment of Minnie Kuo as Chief Operating Officer. Ms. Kuo joined Pliant in September 2023 as Chief Development Officer, bringing more than 20 years of multinational clinical development experience across various therapeutic areas. In this expanded role, Ms. Kuo bridges Pliant’s science and operations with oversight of clinical operations, early development, program management, regulatory affairs and compliance. INTEGRIS-PSC results published in the Journal of Hepatology . The manuscript, “ Phase II INTEGRIS-PSC trial of bexotegrast, an αvβ6 and αvβ1 integrin inhibitor, in primary sclerosing cholangitis ”, appears in the January 2026 issue of the Journal of Hepatology . Fourth Quarter 2025 Financial Results Research and development expenses were $15.6 million as compared to $38.8 million for the prior-year quarter. The decrease was primarily driven by the discontinuation of BEACON-IPF. General and administrative expenses were $8.0 million as compared to $14.5 million for the prior-year quarter. The decrease was primarily due to lower personnel-related costs resulting from the strategic restructuring of our workforce. Net loss was $23.6 million as compared to $49.7 million for the prior-year quarter. The decrease was primarily attributable to the discontinuation of BEACON-IPF coupled with the decrease in personnel-related costs resulting from the strategic restructuring of our workforce. As of December 31, 2025, the Company had cash, cash equivalents and short-term investments of $192.4 million which the Company expects to be sufficient to fund operations into the second half of 2028. About Pliant Therapeutics, Inc. Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of integrin-based therapeutics. The Company’s lead program is PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. Pliant’s early-stage platform includes preclinical research focused on tissue-specific delivery and internalization of drug payloads utilizing integrin receptor-binding molecules. For additional information, please visit: . Follow us on social media X , LinkedIn and Facebook . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These express or implied statements include those regarding PLN-101095's development plan, including anticipated timing of data from our ongoing Phase 1 trial and our Phase 1b indication expansion trial, expansion of our clinical-stage pipeline and creation of shareholder value, and the potential of our integrin-targeted delivery platform, among others. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and our actual results, performance or achievements could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the clinical development of our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, or interactions with regulators, as well as the impact of current macroeconomic, geopolitical and marketplace conditions on our business, operations, clinical supply and plans, our reliance on single-source third parties located in foreign jurisdictions, including China, for critical aspects of our development operations, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the period ended December 31, 2025 which we are filing with the SEC today, available on the SEC's website at Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. Investor and Media Contact: Christopher Keenan Vice President, Investor Relations and Corporate Communications Pliant Therapeutics, Inc. ir@pliantrx.com Pliant Therapeutics, Inc. Condensed Statements of Operations (Unaudited) (In thousands, except number of shares and per share amounts) Three Months Ended December 31, Twelve Months Ended December 31, 2025 2024 2025 2024 Operating expenses: Research and development $ (15,585 ) $ (38,793 ) $ (109,157 ) $ (169,310 ) General and administrative (7,992 ) (14,527 ) (47,216 ) (59,055 ) Total operating expenses (23,577 ) (53,320 ) (156,373 ) (228,365 ) Loss from operations (23,577 ) (53,320 ) (156,373 ) (228,365 ) Interest and other income (expense), net 1,964 4,422 11,416 21,085 Interest expense (136 ) (834 ) (2,559 ) (3,024 ) Loss on extinguishment of debt (1,828 ) — (1,828 ) — Net loss $ (23,577 ) $ (49,732 ) $ (149,344 ) $ (210,304 ) Net loss per share - basic and diluted $ (0.38 ) $ (0.82 ) $ (2.43 ) $ (3.47 ) Shares used in computing net loss per share - basic and diluted 61,449,290 60,854,322 61,366,887 60,538,639 Pliant Therapeutics, Inc. Condensed Balance Sheets (Unaudited) (In thousands) December 31, 2025 December 31, 2024 Assets Current assets Cash and cash equivalents $ 45,445 $ 71,188 Short-term investments 145,499 284,536 Prepaid expenses and other current assets 4,464 6,540 Property and equipment held for sale 1,040 — Total current assets 196,448 362,264 Property and equipment, net 2,940 5,525 Operating lease right-of-use assets 23,966 27,243 Restricted cash 1,482 1,482 Other non-current assets 392 435 Total assets $ 225,228 $ 396,949 Liabilities and stockholders’ equity Current liabilities Accounts payable $ 480 $ 5,960 Accrued research and development 4,804 14,363 Accrued liabilities 9,634 12,353 Lease liabilities, current 1,447 542 Total current liabilities 16,365 33,218 Lease liabilities, non-current 27,658 29,439 Long-term debt — 30,211 Total liabilities 44,023 92,868 Commitments and Contingencies Stockholders’ equity Preferred stock — — Common stock 6 6 Additional paid-in capital 1,040,610 1,013,806 Accumulated deficit (859,396 ) (710,052 ) Accumulated other comprehensive (loss) gain (15 ) 321 Total stockholders’ equity 181,205 304,081 Total liabilities and stockholders’ equity $ 225,228 $ 396,949

Phase 1Financial StatementExecutive ChangeAACRPhase 2

20 Mar 2025

·www.globenewswire.com

Pliant Therapeutics Announces Interim Phase 1 Data for PLN-101095 in Patients with Immune Checkpoint Inhibitor-Refractory Advanced Solid Tumors

Antitumor activity observed with confirmed partial responses in 50% of patients at highest dose tested to date, across multiple tumor types PLN-101095 was generally well tolerated across all doses March 17, 2025 -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced data from the first three of five potential cohorts of its ongoing Phase 1 dose escalation clinical trial evaluating PLN-101095, an integrin αvβ8 and αvβ1 inhibitor, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI) -refractory advanced or metastatic solid tumors. Interim results demonstrated PLN-101095 anti-tumor activity in combination with pembrolizumab, with three partial responses observed in cohort three at the 1000 mg administered orally twice daily (BID) dose, representing a 50% objective response rate (ORR) at the highest dose tested to date. PLN-101095 was generally well tolerated across all doses tested. Nine patients with six different tumor types were enrolled in cohorts one through three of the trial. Patients were treated for 14 days with PLN-101095 at doses of 250 mg, 500 mg or 1000 mg administered orally BID, followed by treatment with a combination of PLN-101095 and pembrolizumab at 200 mg administered intravenously every three weeks (Q3W). Scans were conducted at baseline, Day 14, Week 10, and every 8 weeks thereafter. The Company reported the following initial observations from the trial: Across all doses tested, PLN-101095 was generally well tolerated Of the six patients treated at the 1000 mg BID dose of PLN-101095, three (50%) confirmed partial responses were observed. All three patients remain on treatment. Non-Small Cell Lung Cancer (NSCLC): Confirmed partial response with a 74% reduction in tumor size at Week 18; initial partial response was observed at Week 10 Cholangiocarcinoma: Confirmed partial response with a 48% reduction in tumor size at Week 42; initial partial response was observed at Week 34 Melanoma: Confirmed partial response with a 42% reduction in tumor size at Week 27; initial partial response was observed at Week 18 “We are encouraged by these early responses given the refractory nature of the patient population enrolled in this trial,” said Éric Lefebvre, M.D., Chief Medical Officer of Pliant. “We look forward to sharing the final results from this trial in the future.” The Phase 1 trial of PLN-101095 is currently enrolling the fourth of five potential cohorts. The fourth cohort is evaluating PLN-101095 at 1000 mg, three times daily (TID). PLN-101095 is an oral small molecule inhibitor of integrins αvβ8 and αvβ1. It is currently being evaluated in an ongoing first-in human Phase 1 dose-escalation trial. The open-label trial (NCT06270706) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of PLN-101095 alone and in combination with the immunotherapy pembrolizumab. Activated transforming growth factor-β (TGF-β) has shown to foster an immuno-suppressive tumor microenvironment (TME) that contributes to immune-checkpoint inhibitor (ICI) resistance and treatment failure in cancer.1 Blocking integrins αvβ8 and αvβ1 has shown to prevent the activation of TGF-β and is expected stimulate immune activation by increasing immune cell infiltration into the tumor microenvironment.2,3 In preclinical studies, PLN-101095 demonstrated monotherapy activity in reduction of tumor volume and increased cluster of differentiation (CD)8+ T cell infiltration. In addition, PLN-101095 in combination with an anti-PD-1 monoclonal antibody (mAb) elicited a dose-dependent reduction in tumor volume and increased CD8+ T cell tumor infiltration in the tumor microenvironment compared with anti-PD-1 mAb therapy alone.4 Pliant Therapeutics is a late-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvβ8and αvβ1 integrins that is in development in the lead indication for the treatment of idiopathic pulmonary fibrosis, or IPF. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Medicines Agency in IPF. Pliant is conducting a Phase 1 study for PLN-101095, a small molecule, dual-selective inhibitor of αvβ8 and αvβ1 integrins, that is being developed for the treatment of solid tumors. In addition, Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α7β1 targeting muscular dystrophies. 1 Pickup M. et al. Nat Rev Cancer. 2013 Nov;13(11):788-99. 2 Takasaka N. et al. JCI Insight. 2018 Oct 18;3(20). 3 Reed NI. et al. Sci Transl Med. 2015 May 20;7(288):288ra79. 4 Kothari V, et al. J Immunother Cancer 2022;10(Suppl 2): A1403 abstract 1352 (SITC 2022) The content above comes from the network. if any infringement, please contact us to modify.

$Pliant Therapeutics Announces Interim Phase 1 Data for PLN-101095 in Patients with Immune Checkpoint Inhibitor-Refractory Advanced Solid Tumors$

Orphan DrugFast TrackClinical ResultImmunotherapy

14 Mar 2025

·www.fiercebiotech.com

Pliant, Acelyrin resort to ‘poison pills’ as threat of Concentra buyout looms

Acelyrin was explicit that it had made the changes in response to the “continued rapid accumulation” of 8.8% of the biotech’s stock by Tang Capital Partners.\n With Concentra Biosciences expanding its stock influence in Pliant Therapeutics and Acelyrin, the two biotechs have shored up their corporate defences against a potential acquisition.Both Pliant and Acelyrin have implemented their own “poison pill” plans. The rule changes mean that if a single investor secures 10% or more of either company’s stock, it will trigger certain changes that could make it harder for a buyer to hoover up the remaining shares.Acelyrin was explicit that it had made the changes in response to the “continued rapid accumulation” of 8.8% of the biotech’s stock by Tang Capital Partners. Acelyrin had already turned down a proposal earlier this month to be bought out by Tang-owned Concentra Biosciences, which came in the middle of plans for Acelyrin to merge with immune-mediated disease specialist Alumis. Pliant didn’t namecheck Concentra when erecting its own stock defence, only stating that it is “intended to reduce the likelihood that any entity, person or group is able to gain control of Pliant through open market accumulation without paying all stockholders an appropriate control premium or providing the board sufficient opportunity to make informed judgments and take actions that are in the best interests of all stockholders.”However, a Securities and Exchange Commission filing shows that earlier this month Tang and its various entities together accrued 9.6% of Pliant’s stock.Tang has a track record of swooping in to try to acquire struggling biotechs—with mixed results. The company bought Jounce Therapeutics and Theseus Pharmaceuticals in 2023 but had its advances rejected by Atea Pharmaceuticals, Rain Oncology, LianBio and Kezar Life Sciences.In one instance back in 2023, Quince Therapeutics resorted to a similar poison pill strategy to ward off potential buyers, one of which was Concentra.Pliant seems to fit the bill for a potential Concentra target, with the biotech’s idiopathic pulmonary fibrosis treatment bexotegrast struggling with increased adverse events in a phase 2b/3 trial this year.

Acquisition

100 Deals associated with Bexotegrast

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Phase 3	United States	Pliant Therapeutics, Inc.	27 Sep 2023
Idiopathic Pulmonary Fibrosis	Phase 3	Japan	Pliant Therapeutics, Inc.	27 Sep 2023
Idiopathic Pulmonary Fibrosis	Phase 3	Argentina	Pliant Therapeutics, Inc.	27 Sep 2023
Idiopathic Pulmonary Fibrosis	Phase 3	Australia	Pliant Therapeutics, Inc.	27 Sep 2023
Idiopathic Pulmonary Fibrosis	Phase 3	Belgium	Pliant Therapeutics, Inc.	27 Sep 2023
Idiopathic Pulmonary Fibrosis	Phase 3	Brazil	Pliant Therapeutics, Inc.	27 Sep 2023
Idiopathic Pulmonary Fibrosis	Phase 3	Canada	Pliant Therapeutics, Inc.	27 Sep 2023
Idiopathic Pulmonary Fibrosis	Phase 3	Chile	Pliant Therapeutics, Inc.	27 Sep 2023
Idiopathic Pulmonary Fibrosis	Phase 3	Czechia	Pliant Therapeutics, Inc.	27 Sep 2023
Idiopathic Pulmonary Fibrosis	Phase 3	Denmark	Pliant Therapeutics, Inc.	27 Sep 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04480840 (INTEGRIS-PSC \| INTEGRIS-PSC , CTgov)	Phase 2	Fibrosis, Liver \| Cholangitis, Sclerosing	121	Placebo (Placebo)	fjfkpsjlvm = ohfklixjdn lypqzuswqg (hvhdbitekh, swpfkxmldt - qqabnlrobz) View more	-	23 Jan 2026
				PLN-74809 (PLN-74809 Dose Level 1)	fjfkpsjlvm = gweqnwtrjv lypqzuswqg (hvhdbitekh, zypjcootcn - ubkosuwshp) View more
NCT05621252 (PLN-74809, CTgov)	Phase 2	Idiopathic Pulmonary Fibrosis	10	PLN-74809 (PLN-74809)	qhuwucmrda(vthbbdbfev) = tjbimpuoyh bwwpcstvdo (dcltwbncae, 0.10145) View more	-	24 Sep 2025
				Placebo (Placebo)	qhuwucmrda(vthbbdbfev) = eyiqkyqnun bwwpcstvdo (dcltwbncae, 0.11839) View more
NCT05621252 (ERS2024)	Phase 2	Idiopathic Pulmonary Fibrosis	10	Bexotegrast 160 mg	qjyceibdwt(rnwlyzcvpi) = wcbwpmrgps vkxvivgtpn (mvpyaanhvy )	Positive	07 Sep 2024
				Placebo	yjojwigqdi(riauburrec) = sfjvaorigo ixvnuzyexj (zscykzazsa, 0.068)
NCT04480840 (INTEGRIS-PSC, GlobeNewswire) Manual	Phase 2	Cholangitis, Sclerosing	36	Bexotegrast	vhcpxuiuuy(yixacxwssm) = None qmwhrqayuo (hcamapcxfk ) View more	Positive	15 Jul 2024
				Placebo
NCT04396756 (INTEGRIS-IPF, ATS2024) Manual	Phase 2	Idiopathic Pulmonary Fibrosis	88	Bexotegrast (40 mg)	louhwrejsc(wtrrrigisa) = mbaaqneepp wevcrihncm (ysgvsisgea, 4.80) View more	Positive	21 May 2024
				Bexotegrast (80 mg)	louhwrejsc(wtrrrigisa) = vdocedyzjo wevcrihncm (ysgvsisgea, 4.19) View more
ATS2024	Not Applicable	Idiopathic Pulmonary Fibrosis \| Cholangitis, Sclerosing	-	Bexotegrast	sgbiphekvu(lrwzsiwkip) = The most common system organ class AEs were gastrointestinal-related, including diarrhea, nausea and constipation vpybcfzrwe (bfkngelmqa ) View more	-	19 May 2024
				Placebo
NCT04396756 (INTEGRIS-IPF, CTgov)	Phase 2	Idiopathic Pulmonary Fibrosis	120	Placebo	pfiiohqlmk(hyedcniqrw) = fqaoexodys ivcpdlpxws (cifjoghqrs, hjyxdumxbg - swfxmfriep) View more	-	30 Apr 2024
NCT04480840 (INTEGRIS-PSC, Corporate Publications) Manual	Phase 2	Fibrosis, Liver \| Cholangitis, Sclerosing	121	PLN-74809 40 mg	lpcljvhlde(amwgcsoizs) = slcrjgeiil cfsyiihcpt (riwzevimzd )	Positive	04 Feb 2024
				PLN-74809 80 mg	lpcljvhlde(amwgcsoizs) = ojeadgaisb cfsyiihcpt (riwzevimzd )
NCT04072315 (IPF-201, CTgov)	Phase 2	Idiopathic Pulmonary Fibrosis	9	PLN-74809 (60 mg)	ktjcpcjycq = yjlckmkhrb wonrzhqvcx (xifjbcxafs, doehowtiuf - ogijcqmgpz) View more	-	12 Dec 2023
				PLN-74809 (120 mg and 240 mg)	ktjcpcjycq = gzejfafxoz wonrzhqvcx (xifjbcxafs, mhhlgezaed - rekfmnkwsd) View more
NCT04480840 (INTEGRIS-PSC , Corporate Publications) Manual	Phase 2	Fibrosis, Liver \| Cholangitis, Sclerosing	85	bexotegrast 40 mgbexotegrast 40 mg	jlsqcxaqpz(enhukredqy) = qpafkowqgu mbmvmubnvp (scmzqaoyes )	Positive	26 Sep 2023
				bexotegrastbexotegrast 80 mg	jlsqcxaqpz(enhukredqy) = vlkxnsybql mbmvmubnvp (scmzqaoyes )

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