Pliant Therapeutics Announces Next Steps Following DSMB Recommendation on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis
Pliant Therapeutics (PLRX) has initiated the assembly of an external expert panel to review unblinded data from the ongoing BEACON-IPF Phase 2b trial of bexotegrast in idiopathic pulmonary fibrosis (IPF) patients. This decision follows a recommendation from the trial's independent Data Safety Monitoring Board (DSMB) to pause enrollment and dosing.
The company has been unable to determine the rationale for the DSMB's recommendation through review of blinded data. The newly assembled panel, comprising experts in pulmonary diseases and biostatistics, will provide an independent recommendation and subsequently join an expanded DSMB to reach a consensus recommendation regarding BEACON-IPF.
The process is expected to conclude in 2-4 weeks. Pliant has voluntarily paused enrollment and dosing while maintaining trial blinding to preserve data integrity and the trial's potential registrational status.
Pliant Therapeutics (PLRX) ha avviato la formazione di un pannello di esperti esterni per esaminare i dati non mascherati del trial BEACON-IPF di Fase 2b su bexotegrast in pazienti con fibrosi polmonare idiopatica (IPF). Questa decisione segue una raccomandazione del Comitato Indipendente di Monitoraggio della Sicurezza dei Dati (DSMB) del trial di interrompere l'arruolamento e la somministrazione del farmaco.
L'azienda non è stata in grado di determinare la motivazione della raccomandazione del DSMB attraverso la revisione dei dati mascherati. Il nuovo pannello, composto da esperti in malattie polmonari e biostatistica, fornirà una raccomandazione indipendente e successivamente si unirà a un DSMB ampliato per raggiungere una raccomandazione di consenso riguardo al BEACON-IPF.
Il processo dovrebbe concludersi in 2-4 settimane. Pliant ha volontariamente sospeso l'arruolamento e la somministrazione mantenendo il mascheramento del trial per preservare l'integrità dei dati e il potenziale stato registrativo del trial.
Pliant Therapeutics (PLRX) ha iniciado la formación de un panel de expertos externos para revisar los datos no enmascarados del ensayo BEACON-IPF de Fase 2b sobre bexotegrast en pacientes con fibrosis pulmonar idiopática (IPF). Esta decisión sigue a una recomendación de la Junta de Monitoreo de Seguridad de Datos (DSMB) del ensayo para pausar la inscripción y la dosificación.
La empresa no ha podido determinar la razón de la recomendación del DSMB a través de la revisión de datos enmascarados. El nuevo panel, compuesto por expertos en enfermedades pulmonares y bioestadística, proporcionará una recomendación independiente y posteriormente se unirá a un DSMB ampliado para llegar a una recomendación de consenso sobre BEACON-IPF.
Se espera que el proceso concluya en 2-4 semanas. Pliant ha pausado voluntariamente la inscripción y la dosificación mientras mantiene el enmascaramiento del ensayo para preservar la integridad de los datos y el potencial estado de registro del ensayo.
Pliant Therapeutics (PLRX)는 특발성 폐 섬유증 (IPF) 환자에 대한 bexotegrast의 진행 중인 BEACON-IPF 2b 임상 시험에서 비공식 데이터를 검토하기 위해 외부 전문가 패널을 구성하기 시작했습니다. 이 결정은 임상 시험의 독립 데이터 안전성 모니터링 위원회 (DSMB)의 권고에 따라 등록 및 투여를 일시 중단하기로 한 것입니다.
회사는 블라인드 데이터 검토를 통해 DSMB의 권고 이유를 확인할 수 없었습니다. 폐 질환 및 생물통계학 전문가로 구성된 새롭게 구성된 패널은 독립적인 권고를 제공하고 이후 확대된 DSMB에 합류하여 BEACON-IPF에 대한 합의 권고를 도출할 것입니다.
이 과정은 2-4주 이내에 마무리될 것으로 예상됩니다. Pliant는 데이터 무결성과 임상 시험의 잠재적 등록 상태를 유지하기 위해 임상 시험 블라인드를 유지하면서 자발적으로 등록 및 투여를 일시 중단했습니다.
Pliant Therapeutics (PLRX) a lancé la constitution d'un panel d'experts externes pour examiner les données non masquées de l'essai BEACON-IPF de Phase 2b sur le bexotegrast chez des patients atteints de fibrose pulmonaire idiopathique (IPF). Cette décision fait suite à une recommandation du Comité Indépendant de Surveillance de la Sécurité des Données (DSMB) de suspendre l'inscription et l'administration du traitement.
L'entreprise n'a pas été en mesure de déterminer la raison de la recommandation du DSMB par l'examen des données masquées. Le nouveau panel, composé d'experts en maladies pulmonaires et en biostatistique, fournira une recommandation indépendante et rejoindra ensuite un DSMB élargi pour parvenir à une recommandation consensuelle concernant le BEACON-IPF.
Le processus devrait se conclure dans 2-4 semaines. Pliant a volontairement suspendu l'inscription et l'administration tout en maintenant le masquage de l'essai pour préserver l'intégrité des données et le statut potentiel d'enregistrement de l'essai.
Pliant Therapeutics (PLRX) hat die Bildung eines externen Expertengremiums eingeleitet, um die nicht verblindeten Daten der laufenden BEACON-IPF Phase 2b Studie zu bexotegrast bei Patienten mit idiopathischer pulmonaler Fibrose (IPF) zu überprüfen. Diese Entscheidung folgt einer Empfehlung des unabhängigen Data Safety Monitoring Boards (DSMB), die Rekrutierung und Dosierung auszusetzen.
Das Unternehmen war nicht in der Lage, die Gründe für die Empfehlung des DSMB durch die Überprüfung der verblindeten Daten zu ermitteln. Das neu gebildete Gremium, das aus Experten für Lungenerkrankungen und Biostatistik besteht, wird eine unabhängige Empfehlung abgeben und sich anschließend einem erweiterten DSMB anschließen, um eine Konsensempfehlung bezüglich BEACON-IPF zu erreichen.
Der Prozess wird voraussichtlich in 2-4 Wochen abgeschlossen sein. Pliant hat die Rekrutierung und Dosierung freiwillig ausgesetzt, während das Blindverfahren des Trials beibehalten wird, um die Datenintegrität und den potenziellen Registrierungsstatus des Trials zu wahren.
- Trial maintains potential to serve as a registrational study
- Company taking proactive steps with expert panel assembly
- Short timeline of 2-4 weeks for expert panel review completion
- Enrollment and dosing in BEACON-IPF trial currently paused
- DSMB recommendation indicates potential safety or efficacy concerns
- Uncertainty regarding the reason for DSMB's pause recommendation
Insights
The pause in Pliant's BEACON-IPF Phase 2b/3 trial of bexotegrast represents a critical juncture for both the company and its lead program. The unusual circumstance where the company cannot determine the DSMB's concerns through blinded data review suggests potential complexities in the safety or efficacy signals that require specialized expertise to evaluate.
Several key aspects warrant attention: First, Pliant's decision to assemble world-renowned experts in pulmonary diseases and biostatistics indicates a thorough, systematic approach to addressing the DSMB's concerns. This proactive stance, while potentially extending the timeline by 2-4 weeks, demonstrates commitment to maintaining scientific rigor and data integrity.
Particularly noteworthy is Pliant's emphasis on preserving the trial's potential as a registrational study. This strategic decision suggests confidence in the underlying trial design and data quality, despite the current challenges. The maintenance of blinding is crucial, as breaking the blind could compromise the trial's statistical validity and its potential use for registration purposes.
The implications for Pliant are substantial, considering that bexotegrast represents a significant portion of their pipeline value. IPF is a highly competitive therapeutic area with significant unmet medical needs, and any delay in development could impact the company's market position. However, the methodical approach to resolving the DSMB's concerns, while maintaining trial integrity, may prove beneficial in the long term, particularly for regulatory discussions.
The expanded DSMB structure, incorporating the expert panel, creates a robust framework for decision-making that could either validate the trial's continuation under modified parameters or identify significant concerns requiring more substantial protocol modifications. This process, while adding time to the development timeline, provides a thorough safety review that could strengthen the program's overall risk-benefit profile.
Pliant has initiated assembly of outside panel of world-renowned experts to review BEACON-IPF trial data
SOUTH SAN FRANCISCO, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that, per the charter of the trial’s independent Data Safety Monitoring Board (DSMB), the Company has initiated the assembly of an outside expert panel to review unblinded data from the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The panel, consisting of world-renowned experts in pulmonary diseases and biostatistics, will provide an independent recommendation to Pliant regarding the BEACON-IPF trial. Subsequently, the panel will serve as part of an expanded DSMB with the goal to reach a consensus recommendation regarding BEACON-IPF. The decision to assemble the outside panel was taken as the Company has not been able, through review of blinded data, to determine the rationale for the DSMB’s recommendation to pause enrollment and dosing in the trial. The Company expects this process to conclude in two to four weeks.
Following the DSMB’s previously announced recommendation, Pliant voluntarily paused enrollment and dosing in the BEACON-IPF clinical trial. Pliant is committed to remaining blinded ensuring the data integrity of the BEACON-IPF 2b clinical trial with the goal of maintaining its potential to serve as a registrational trial.
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 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 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 Company’s, the DSMB’s and the outside expert panel’s further review and analysis of data, the ability of the outside expert panel and the DSMB to reach a consensus recommendation regarding BEACON-IPF and the timing thereof, and the Company’s current and future plans for bexotegrast and the BEACON-IPF clinical trial. 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 risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, and our capital requirements and the need for additional financing, including the availability of additional term loans under our loan facility. 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 caused the pause in Pliant's (PLRX) BEACON-IPF Phase 2b/3 trial?
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