Pliant Therapeutics Presents Data from its Bexotegrast Program at The Liver Meeting® 2024
Pliant Therapeutics (PLRX) presented clinical data for bexotegrast, their oral integrin inhibitor, at The Liver Meeting® 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 Meeting® 2024. I risultati della fase 2 dello studio INTEGRIS-PSC hanno dimostrato che bexotegrast è stato ben tollerato e ha mostrato attività antifibrotica e anti-colestatica nei pazienti con colangite sclerosante primaria (PSC). Il farmaco ha migliorato la rigidità 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) presentó datos clínicos sobre bexotegrast, su inhibidor de integrina oral, en The Liver Meeting® 2024. Los resultados del estudio de fase 2 INTEGRIS-PSC mostraron que bexotegrast fue bien tolerado y demostró actividad antifibrótica y anti-colestática en pacientes con colangitis esclerosante primaria (PSC). El medicamento mejoró la rigidez hepática, los puntajes de Enhanced Liver Fibrosis, la bioquímica hepática y los resultados de la resonancia magnética.
Además, la compañía presentó una investigación que identifica nuevos biomarcadores inflamatorios para la PSC a través de un cribado proteómico, descubriendo candidatos potenciales de biomarcadores en suero y orina que podrían ayudar a predecir la progresión de la enfermedad.
Pliant Therapeutics (PLRX)는 2024년 The Liver Meeting®에서 그들의 경구용 인테그린 억제제인 bexotegrast에 대한 임상 데이터를 발표했습니다. 2상 INTEGRIS-PSC 시험 결과, bexotegrast는 잘 견뎌졌으며 원발성 경화성 담관염 (PSC) 환자에서 항섬유화 및 항담즙활동을 나타냈습니다. 이 약물은 간 경직도, Enhanced Liver Fibrosis 점수, 간 생화학 및 MRI 결과를 개선했습니다.
또한, 회사는 단백질체 스크리닝을 통해 PSC에 대한 새로운 염증 바이오마커를 식별하는 연구를 발표하고, 질병 진행 예측에 도움이 될 수 있는 혈청 및 소변 바이오마커 후보를 발견했습니다.
Pliant Therapeutics (PLRX) a présenté des données cliniques sur bexotegrast, leur inhibiteur oral des intégrines, lors de The Liver Meeting® 2024. Les résultats de l'essai INTEGRIS-PSC de phase 2 ont montré que bexotegrast a été bien toléré et a montré une activité antifibrotique et anti-cholestatique chez les patients atteints de cholangite sclérosante primaire (PSC). Le médicament a amélioré la rigidité hépatique, les scores d'Enhanced Liver Fibrosis, la biochimie hépatique et les résultats de l'IRM.
De plus, la société a présenté des recherches identifiant de nouveaux biomarqueurs inflammatoires pour la PSC grâce à un dépistage protéomique, découvrant des candidats potentiels de biomarqueurs sériques et urinaires qui pourraient aider à prédire la progression de la maladie.
Pliant Therapeutics (PLRX) hat auf The Liver Meeting® 2024 klinische Daten zu bexotegrast, ihrem oralen Integrin-Inhibitor, präsentiert. Die Ergebnisse der Phase-2-Studie INTEGRIS-PSC zeigten, dass bexotegrast gut verträglich war und antifibrotische sowie anti-cholestatische Aktivität bei Patienten mit primärer sklerosierender Cholangitis (PSC) zeigte. Das Medikament verbesserte die Lebersteifigkeit, Enhanced Liver Fibrosis Scores, die Leberbiochemie und die MRI-Ergebnisse.
Darüber hinaus präsentierte das Unternehmen Forschungsergebnisse, die neue entzündliche Biomarker für PSC durch proteomisches Screening identifizieren, und entdeckte potenzielle Serum- und Urin-Biomarkerkandidaten, die zur Vorhersage des Krankheitsverlaufs beitragen könnten.
- 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
- None.
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 Meeting® 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 αvß6 and αvß1 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 αvß8 and αvß1 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.
For additional information, please visit: www.PliantRx.com. 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 statements include those regarding the safety, tolerability, pharmacodynamics and therapeutic potential of bexotegrast; our plans for the future development of bexotegrast; and bexotegrast’s 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
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