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Pliant Therapeutics (PLRX) presented clinical data for bexotegrast, their oral integrin inhibitor, at The Liver MeetingĀ® 2024. The Phase 2 INTEGRIS-PSC trial results showed that bexotegrast was well-tolerated and demonstrated antifibrotic and anti-cholestatic activity in primary sclerosing cholangitis (PSC) patients. The drug improved liver stiffness, Enhanced Liver Fibrosis scores, liver biochemistry, and MRI results.
Additionally, the company presented research identifying novel inflammatory biomarkers for PSC through proteomic screening, discovering potential serum and urine biomarker candidates that could help predict disease progression.
Pliant Therapeutics (PLRX) ha presentato dati clinici per bexotegrast, il loro inibitore orale degli integrini, durante The Liver MeetingĀ® 2024. I risultati della fase 2 dello studio INTEGRIS-PSC hanno dimostrato che bexotegrast ĆØ stato ben tollerato e ha mostrato attivitĆ antifibrotica e anti-colestatica nei pazienti con colangite sclerosante primaria (PSC). Il farmaco ha migliorato la rigiditĆ epatica, i punteggi Enhanced Liver Fibrosis, la biochimica epatica e i risultati della risonanza magnetica.
Inoltre, l’azienda ha presentato una ricerca che identifica nuovi biomarcatori infiammatori per la PSC attraverso uno screening proteomico, scoprendo potenziali candidati di biomarcatori sierici e urinari che potrebbero aiutare a prevedere la progressione della malattia.
Pliant Therapeutics (PLRX) presentĆ³ datos clĆnicos sobre bexotegrast, su inhibidor de integrina oral, en The Liver MeetingĀ® 2024. Los resultados del estudio de fase 2 INTEGRIS-PSC mostraron que bexotegrast fue bien tolerado y demostrĆ³ actividad antifibrĆ³tica y anti-colestĆ”tica en pacientes con colangitis esclerosante primaria (PSC). El medicamento mejorĆ³ la rigidez hepĆ”tica, los puntajes de Enhanced Liver Fibrosis, la bioquĆmica hepĆ”tica y los resultados de la resonancia magnĆ©tica.
AdemĆ”s, la compaƱĆa presentĆ³ una investigaciĆ³n que identifica nuevos biomarcadores inflamatorios para la PSC a travĆ©s de un cribado proteĆ³mico, descubriendo candidatos potenciales de biomarcadores en suero y orina que podrĆan ayudar a predecir la progresiĆ³n de la enfermedad.
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ėķ, ķģ¬ė ėØė°±ģ§ģ²“ ģ¤ķ¬ė¦¬ėģ ķµķ“ PSCģ ėķ ģė”ģ“ ģ¼ģ¦ ė°ģ“ģ¤ė§ģ»¤ė„¼ ģė³ķė ģ°źµ¬ė„¼ ė°ķķź³ , ģ§ė³ ģ§ķ ģģø”ģ ėģģ“ ė ģ ģė ķģ² ė° ģė³ ė°ģ“ģ¤ė§ģ»¤ ķė³“ė„¼ ė°ź²¬ķģµėė¤.
Pliant Therapeutics (PLRX) a prĆ©sentĆ© des donnĆ©es cliniques sur bexotegrast, leur inhibiteur oral des intĆ©grines, lors de The Liver MeetingĀ® 2024. Les rĆ©sultats de l’essai INTEGRIS-PSC de phase 2 ont montrĆ© que bexotegrast a Ć©tĆ© bien tolĆ©rĆ© et a montrĆ© une activitĆ© antifibrotique et anti-cholestatique chez les patients atteints de cholangite sclĆ©rosante primaire (PSC). Le mĆ©dicament a amĆ©liorĆ© la rigiditĆ© hĆ©patique, les scores d’Enhanced Liver Fibrosis, la biochimie hĆ©patique et les rĆ©sultats de l’IRM.
De plus, la sociĆ©tĆ© a prĆ©sentĆ© des recherches identifiant de nouveaux biomarqueurs inflammatoires pour la PSC grĆ¢ce Ć un dĆ©pistage protĆ©omique, dĆ©couvrant des candidats potentiels de biomarqueurs sĆ©riques et urinaires qui pourraient aider Ć prĆ©dire la progression de la maladie.
Pliant Therapeutics (PLRX) hat auf The Liver MeetingĀ® 2024 klinische Daten zu bexotegrast, ihrem oralen Integrin-Inhibitor, prƤsentiert. Die Ergebnisse der Phase-2-Studie INTEGRIS-PSC zeigten, dass bexotegrast gut vertrƤglich war und antifibrotische sowie anti-cholestatische AktivitƤt bei Patienten mit primƤrer sklerosierender Cholangitis (PSC) zeigte. Das Medikament verbesserte die Lebersteifigkeit, Enhanced Liver Fibrosis Scores, die Leberbiochemie und die MRI-Ergebnisse.
DarĆ¼ber hinaus prƤsentierte das Unternehmen Forschungsergebnisse, die neue entzĆ¼ndliche Biomarker fĆ¼r PSC durch proteomisches Screening identifizieren, und entdeckte potenzielle Serum- und Urin-Biomarkerkandidaten, die zur Vorhersage des Krankheitsverlaufs beitragen kƶnnten.
Positive
- Bexotegrast demonstrated positive clinical results in Phase 2 INTEGRIS-PSC trial
- Drug showed good tolerability across all tested doses
- Multiple improvements observed in liver-related markers and measurements
- Successful identification of new diagnostic biomarkers for PSC
Insights
The INTEGRIS-PSC Phase 2 trial results represent significant progress for bexotegrast in treating primary sclerosing cholangitis (PSC), a rare liver disease with no approved treatments. The data shows promising antifibrotic and anti-cholestatic activity across multiple clinically relevant measures.
The drug demonstrated improvements in key markers including liver stiffness, Enhanced Liver Fibrosis scores and liver biochemistry. The positive safety profile across all doses is particularly noteworthy for a chronic treatment. The identification of novel biomarkers could also help improve patient monitoring and disease progression prediction.
While these results are encouraging for PSC patients, larger Phase 3 trials will be needed to confirm efficacy. For Pliant, success in this indication could represent a significant market opportunity given the lack of approved therapies.
INTEGRIS-PSC featured in an oral late breaker presentation
SOUTH SAN FRANCISCO, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) — Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today announced the presentation of clinical data at The Liver MeetingĀ® 2024 of the American Association for the Study of Liver Diseases (AASLD) being held in San Diego, California.
In an oral late breaker presentation, Kris Kowdley, M.D., Director, Liver Institute Northwest and Professor of Medicine, Elson S. Floyd College of Medicine at Washington State University, reviewed the positive data from the INTEGRIS-PSC trial that demonstrated bexotegrast was well tolerated across all doses tested and displayed antifibrotic and anti-cholestatic activity across multiple measures in patients with primary sclerosing cholangitis (PSC). Improvements included improvements in liver stiffness, Enhanced Liver Fibrosis (ELF) scores, as well as liver biochemistry and magnetic resonance imaging (MRI).
Identification of novel inflammatory serum and urinary protein biomarkers for PSC
In a poster presentation, Johanna Schaub, Ph.D., Principal Scientist II, Translational Sciences at Pliant Therapeutics, presented a study that combined two unique proteomic screening approaches to identify novel diagnostic biomarkers in patients with PSC. Results showed the discovery of dozens of putative serum and urine biomarker candidates along with previously described biomarkers, validating this approach. In addition, this approach yielded proteins previously proposed to predict progression in primary biliary cholangitis and cirrhosis, suggesting a role in predicting progression in PSC.
The posters presented at AASLD will be made available on the Publications page of the Pliant website, www.PliantRx.com, at the time of presentation.
About Pliant Therapeutics, Inc.
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 Ī±vĆ6 and Ī±vĆ1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant has initiated BEACON-IPF, an adaptive Phase 2b/3 trial of bexotegrast in IPF. Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of Ī±vĆ8 and Ī±vĆ1 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 Ī±7Ī²1 targeting muscular dystrophies.
For additional information, please visit:Ā www.PliantRx.com. Follow us onĀ 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 statements include those regarding the safety, tolerability, pharmacodynamics and therapeutic potential of bexotegrast; our plans for the future development of bexotegrast; and bexotegrastās potential to become a treatment for PSC. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant Therapeutics 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 development and commercialization of our product candidates, including the impact of current regulatory, macroeconomic and marketplace conditions, our reliance on third parties 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, including the availability of additional term loans under our loan facility, 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 Quarterly Report on Form 10-Q for the period ended September 30, 2024, which is available on the SEC’s website at www.sec.gov. 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
FAQ
What were the main results of Pliant Therapeutics (PLRX) Phase 2 INTEGRIS-PSC trial?
The trial showed that bexotegrast was well-tolerated and demonstrated antifibrotic and anti-cholestatic activity, improving liver stiffness, Enhanced Liver Fibrosis scores, liver biochemistry, and MRI results in PSC patients.
What did Pliant Therapeutics (PLRX) present at The Liver Meeting 2024?
Pliant presented clinical data for bexotegrast from the INTEGRIS-PSC Phase 2 trial and research on novel inflammatory biomarkers for PSC through proteomic screening.
What is bexotegrast’s mechanism of action in Pliant’s (PLRX) PSC treatment?
Bexotegrast is an oral inhibitor of Ī±vĪ²6 and Ī±vĪ²1 integrins, designed to treat primary sclerosing cholangitis (PSC).
