Pliant Therapeutics Presents Data from its Bexotegrast Program at the European Respiratory Society International Congress 2024
Pliant Therapeutics (Nasdaq: PLRX) presented data from its bexotegrast program at the European Respiratory Society International Congress 2024. Key findings include:
1. Reduction in type 1 collagen deposition in IPF patients after 12 weeks of bexotegrast treatment, suggesting antifibrotic effects and favorable lung remodeling.
2. Integrated safety summary showing bexotegrast was well-tolerated in Phase 2a trials for IPF and PSC.
3. Preclinical data demonstrating antifibrotic effects in lung slices from various ILD patients, supporting further investigation in ILD-associated progressive pulmonary fibrosis.
4. Post-hoc biomarker analysis revealing reduced levels of ILD progression markers in IPF patients receiving bexotegrast.
Pliant Therapeutics (Nasdaq: PLRX) ha presentato dati dal suo programma bexotegrast al Congresso Internazionale della Società Europea di Respirazione 2024. I risultati chiave includono:
1. Riduzione nella deposizione di collagene di tipo 1 nei pazienti con IPF dopo 12 settimane di trattamento con bexotegrast, suggerendo effetti antifibrotici e un favorevole rimodellamento polmonare.
2. Riassunto integrato di sicurezza che dimostra come bexotegrast sia stato ben tollerato negli studi di Fase 2a per IPF e PSC.
3. Dati preclinici che mostrano effetti antifibrotici in campioni polmonari da vari pazienti con ILD, supportando ulteriori indagini nella fibrosi polmonare progressiva associata a ILD.
4. Analisi post-hoc dei biomarcatori che rivela livelli ridotti di marcatori di progressione dell'ILD nei pazienti IPF che ricevono bexotegrast.
Pliant Therapeutics (Nasdaq: PLRX) presentó datos de su programa bexotegrast en el Congreso Internacional de la Sociedad Europea de Respiración 2024. Los hallazgos clave incluyen:
1. Reducción en la deposición de colágeno tipo 1 en pacientes con IPF después de 12 semanas de tratamiento con bexotegrast, sugiriendo efectos antifibróticos y un remodelado pulmonar favorable.
2. Resumen de seguridad integrado que muestra que bexotegrast fue bien tolerado en ensayos de Fase 2a para IPF y PSC.
3. Datos preclínicos que demuestran efectos antifibróticos en cortes de pulmón de varios pacientes con ILD, apoyando una mayor investigación en la fibrosis pulmonar progresiva asociada a ILD.
4. Análisis post-hoc de biomarcadores que revela niveles reducidos de marcadores de progresión de ILD en pacientes con IPF que reciben bexotegrast.
Pliant Therapeutics (Nasdaq: PLRX)는 유럽 호흡기 학회 국제 회의 2024에서 bexotegrast 프로그램의 데이터를 발표했습니다. 주요 결과는 다음과 같습니다:
1. 12주간의 bexotegrast 치료 후 IPF 환자에서 1형 콜라겐 침착의 감소가 관찰되어, 항섬유화 효과와 유리한 폐 재형성을 시사합니다.
2. IPF 및 PSC에 대한 2단계 임상 시험에서 bexotegrast가 잘 견딜 수 있었다는 통합 안전성 요약.
3. 여러 ILD 환자의 폐 절편에서 항섬유화 효과를 입증하는 전임상 데이터가 있으며, ILD와 관련된 진행성 폐 섬유증에 대한 추가 조사를 지원합니다.
4. bexotegrast를 받는 IPF 환자에서 ILD 진행 마커의 수준 감소를 나타내는 후향적 바이오마커 분석 결과.
Pliant Therapeutics (Nasdaq: PLRX) a présenté des données de son programme bexotegrast lors du Congrès International de la Société Européenne de Pneumologie 2024. Les résultats clés incluent :
1. Réduction de la déposition de collagène de type 1 chez des patients atteints de fibrose pulmonaire idiopathique (IPF) après 12 semaines de traitement par bexotegrast, suggérant des effets antifibrotiques et un remodelage pulmonaire favorable.
2. Résumé de sécurité intégré montrant que bexotegrast a été bien toléré lors des essais de phase 2a pour l'IPF et PSC.
3. Données précliniques démontrant des effets antifibrotiques sur des coupes pulmonaires de divers patients atteints de maladies interstitielles pulmonaires (ILD), soutenant une enquête plus approfondie sur la fibrose pulmonaire progressive associée à l'ILD.
4. Analyse post-hoc des biomarqueurs révélant des niveaux réduits de marqueurs de progression de l'ILD chez les patients IPF recevant bexotegrast.
Pliant Therapeutics (Nasdaq: PLRX) hat Daten aus seinem bexotegrast Programm auf dem Internationalen Kongress der Europäischen Respiratory Society 2024 präsentiert. Wichtige Ergebnisse umfassen:
1. Reduktion der Ablagerung von Typ-1-Kollagen bei IPF-Patienten nach 12 Wochen Behandlung mit bexotegrast, was auf antifibrotische Effekte und eine günstige Lungensanierung hinweist.
2. Integrierte Sicherheitszusammenfassung, die zeigt, dass bexotegrast gut vertragen wurde in Phase 2a Studien für IPF und PSC.
3. Präklinische Daten, die antifibrotische Effekte in Lungenproben von verschiedenen ILD-Patienten demonstrieren, unterstützen eine weitere Untersuchung der mit ILD assoziierten progressiven Lungenfibrose.
4. Post-hoc Biomarker-Analyse zeigt verringerte Werte von ILD-Fortschrittsmarkern bei IPF-Patienten, die bexotegrast erhalten.
- Bexotegrast demonstrated reduction in type 1 collagen deposition in IPF patients, suggesting antifibrotic effects
- Safety data from Phase 2a trials showed bexotegrast was well-tolerated with no related serious adverse events
- Preclinical data supports antifibrotic activity of bexotegrast in various ILD lung explants
- Post-hoc analysis showed reduced levels of ILD progression biomarkers in patients receiving bexotegrast
- None.
SOUTH SAN FRANCISCO, Calif., Sept. 10, 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, announced its presentations at the European Respiratory Society (ERS) International Congress 2024 taking place in Vienna, Austria September 7 - 11, 2024.
“Presentations made by Pliant colleagues and investigators at the 2024 ERS Congress include additional clinical data from our recently announced type 1 collagen PET imaging study, an integrated safety summary from our INTEGRIS clinical programs and non-clinical data from our bexotegrast development program. Taken together, these data provide further support for the late-stage development of this novel therapeutic as part of our ongoing BEACON-IPF trial,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics.
In a late-breaker oral presentation, Sydney B. Montesi, M.D., Assistant Professor of Medicine at Massachusetts General Hospital, Havard Medical School presented results from the first interventional Phase 2, single-center, randomized, double-blind, placebo-controlled trial (NCT05621252) evaluating type 1 collagen deposition by positron emission tomography (PET) imaging in the lungs of participants with IPF. 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.
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.
In a late-breaker oral presentation, Johanna Schaub, Ph.D., Principal Scientist II, Translational Sciences at Pliant Therapeutics, presented a study assessing the antifibrotic effects of bexotegrast, a dual αvβ6/αvβ1 integrin inhibitor, in precision cut-lung slices from patients with progressive fibrosing interstitial lung diseases (ILD) other than IPF. Results showed that integrin αvβ6 levels were increased in lungs from patients with a diverse set of fibrotic ILDs and that bexotegrast decreased profibrogenic gene expression in lung slices generated from a wide range of ILD lung explants. In addition, the antifibrotic activity of bexotegrast was found to be similar in slices from IPF and non-IPF explants. These data support the further investigation into the antifibrotic activity of bexotegrast in ILD-associated progressive pulmonary fibrosis (PFF).
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). Further analyses of plasma biomarkers are included as part of the ongoing global Phase 2b/3 BEACON-IPF trial.
Posters presented at the ERS International Congress 2024 are available on Pliant’s website under the Publications section at https://pliantrx.com/publications.
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 potential for the future development of bexotegrast. 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 any delays in our ongoing or planned preclinical or clinical trials, the impact of current macroeconomic and marketplace conditions, including the effects of COVID-19, on our business, operations, clinical supply and plans, 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 June 30, 2024 which we filed with the SEC on August 7, 2024, and 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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