Pliant Therapeutics Provides Update on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis
Pliant Therapeutics (PLRX) has announced a voluntary pause in enrollment and dosing in its BEACON-IPF Phase 2b trial of bexotegrast for idiopathic pulmonary fibrosis (IPF) patients. This decision follows recommendations from the trial's independent Data Safety Monitoring Board (DSMB) after a prespecified data review.
Currently enrolled patients will remain in the trial while the company reviews data to understand the DSMB's recommendation. The study will maintain its blinding to preserve trial integrity. The company has informed trial investigators and is notifying global regulatory authorities about this development.
Pliant Therapeutics (PLRX) ha annunciato una pausa volontaria nell'arruolamento e nella somministrazione nel suo studio di fase 2b BEACON-IPF per i pazienti affetti da fibrosi polmonare idiopatica (IPF). Questa decisione segue le raccomandazioni dell'independent Data Safety Monitoring Board (DSMB) dello studio dopo una revisione dei dati già programmata.
I pazienti attualmente arruolati rimarranno nello studio mentre l'azienda esamina i dati per comprendere la raccomandazione del DSMB. Lo studio manterrà il suo Mascheramento per preservare l'integrità dello studio. L'azienda ha informato i ricercatori dello studio e sta notificando le autorità regolatorie globali riguardo a questo sviluppo.
Pliant Therapeutics (PLRX) ha anunciado una pausa voluntaria en la inscripción y dosificación en su ensayo de fase 2b BEACON-IPF de bexotegrast para pacientes con fibrosis pulmonar idiopática (IPF). Esta decisión sigue las recomendaciones de la Junta Independiente de Monitoreo de Datos y Seguridad (DSMB) del ensayo después de una revisión de datos preestablecida.
Los pacientes actualmente inscritos permanecerán en el ensayo mientras la empresa revisa los datos para entender la recomendación del DSMB. El estudio mantendrá su enmascaramiento para preservar la integridad del ensayo. La empresa ha informado a los investigadores del ensayo y está notificando a las autoridades regulatorias globales sobre este desarrollo.
플라이언트 테라퓨틱스 (PLRX)는 특발성 폐섬유증 (IPF) 환자를 위한 bexotegrast의 BEACON-IPF 2b상 시험에서 등록 및 투여를 자발적으로 중단한다고 발표했습니다. 이 결정은 사전 지정된 데이터 검토 후 시험의 독립적인 데이터 안전 모니터링 위원회(DSMB)로부터의 권고에 따른 것입니다.
현재 등록된 환자는 회사가 DSMB의 권고를 이해하기 위해 데이터를 검토하는 동안 계속 시험에 남아 있게 됩니다. 이 연구는 시험의 무결성을 유지하기 위해 블라인딩을 유지할 것입니다. 회사는 시험 연구자에게 이를 알리고 있으며, 글로벌 규제 당국에 이 발전에 대해 통지하고 있습니다.
Pliant Therapeutics (PLRX) a annoncé une pause volontaire dans le recrutement et l'administration de son essai BEACON-IPF de phase 2b de bexotegrast pour les patients atteints de fibrose pulmonaire idiopathique (IPF). Cette décision fait suite aux recommandations du Comité de Surveillance Indépendant des Données et de la Sécurité (DSMB) de l'essai après une revue des données prédéfinie.
Les patients actuellement inscrits resteront dans l'essai pendant que la société examine les données pour comprendre la recommandation du DSMB. L'étude maintiendra son anonymat pour préserver l'intégrité de l'essai. La société a informé les investigateurs de l'essai et notifie les autorités réglementaires mondiales concernant ce développement.
Pliant Therapeutics (PLRX) hat eine freiwillige Pause bei der Rekrutierung und Dosierung in seiner BEACON-IPF Phase 2b Studie zu bexotegrast für Patienten mit idiopathischer Lungenfibrose (IPF) angekündigt. Diese Entscheidung erfolgt auf Grundlage von Empfehlungen des unabhängigen Datensicherheits- und Überwachungsausschusses (DSMB) nach einer vorab festgelegten Datenüberprüfung.
Die derzeit eingeschriebenen Patienten bleiben in der Studie, während das Unternehmen die Daten überprüft, um die Empfehlung des DSMB zu verstehen. Die Studie wird ihre Blinding-Phase aufrechterhalten, um die Integrität der Studie zu bewahren. Das Unternehmen hat die Studienleiter informiert und benachrichtigt weltweit die Regulierungsbehörden über diese Entwicklung.
- None.
- Enrollment and dosing pause in BEACON-IPF Phase 2b trial
- DSMB safety concerns requiring review of trial data
- Potential delays in trial completion and drug development timeline
- Possible impact on regulatory approval pathway
Insights
The voluntary pause in Pliant's BEACON-IPF Phase 2b trial represents a significant clinical development that could materially impact the company's lead program. Several key aspects deserve careful consideration:
The decision to maintain trial blinding while pausing enrollment and dosing is particularly noteworthy. This suggests the DSMB's recommendation likely stems from a pre-specified analysis trigger rather than an acute safety concern, as immediate safety issues typically require unblinding. However, any pause in a Phase 2b/3 trial warrants careful investor attention given the substantial resources invested and the critical nature of this stage in drug development.
For context, the IPF therapeutic landscape has historically seen similar trial pauses, with outcomes ranging from brief delays to program terminations. The fact that currently enrolled patients will remain in the trial is a moderately encouraging sign, as complete trial terminations typically involve immediate discontinuation of all dosing.
From an investor perspective, this development introduces considerable uncertainty around three critical areas:
- Timeline implications: Even if resolved favorably, this pause will likely result in enrollment delays and potential protocol modifications
- Program viability: The outcome of the data review could range from a simple restart to major protocol amendments or, in a worst-case scenario, program termination
- Financial impact: Extended trial delays could affect the company's cash runway and development timelines
While maintaining trial integrity through continued blinding is methodologically sound, it also means investors will likely face an extended period of uncertainty until the company completes its review and provides updates. The immediate market response may be cautious given this uncertainty, but the ultimate impact will depend entirely on the findings from the data review and subsequent decisions regarding trial continuation.
Following DSMB recommendation, the Company has voluntarily paused enrollment and dosing in the BEACON-IPF Phase 2b trial and will monitor current patients while data is reviewed
SOUTH SAN FRANCISCO, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that following a prespecified data review and recommendations by the trial’s independent Data Safety Monitoring Board (DSMB), the Company has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). Patients currently enrolled in BEACON-IPF will remain in the trial.
Enrollment and dosing have been paused while data is reviewed to understand the DSMB’s rationale for their recommendation. Blinding of the study will be maintained to preserve trial integrity. The Company has informed BEACON-IPF clinical trial investigators and is in the process of informing global regulatory authorities.
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 and the DSMB’s further review and analysis of data, interactions with the DSMB and global regulatory authorities, 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
Why did Pliant Therapeutics (PLRX) pause the BEACON-IPF trial?
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