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PureTech to Present at CHEST 2024 Annual Meeting

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PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) announced its participation in the CHEST 2024 Annual Meeting in Boston from October 6-9. The company will present three studies related to LYT-100 (deupirfenidone) for treating idiopathic pulmonary fibrosis (IPF). These presentations will inform clinical, commercial, and patient engagement strategies for LYT-100.

Key points:

  • Topline data from the Phase 2b ELEVATE IPF trial of LYT-100 is expected by the end of 2024
  • A streamlined development program is planned, potentially advancing to Phase 3 pending positive outcomes and regulatory feedback
  • PureTech believes successful Phase 2b and Phase 3 trials could support registration in the U.S. and other regions

The presentations will cover patient experiences at ILD centers vs. community practices, the ongoing burden of IPF in the antifibrotic era, and a Bayesian approach for the ELEVATE IPF trial.

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ha annunciato la sua partecipazione al CHEST 2024 Annual Meeting a Boston dal 6 al 9 ottobre. La società presenterà tre studi relativi a LYT-100 (deupirfenidone) per il trattamento dell'fibrosi polmonare idiopatica (IPF). Queste presentazioni informeranno le strategie cliniche, commerciali e di coinvolgimento dei pazienti per LYT-100.

Punti chiave:

  • I dati preliminari del trial di fase 2b ELEVATE IPF di LYT-100 sono attesi entro la fine del 2024
  • È previsto un programma di sviluppo semplificato, con la possibilità di avanzare alla fase 3 in base a risultati positivi e feedback normativo
  • PureTech crede che il successo degli studi di fase 2b e fase 3 potrebbe supportare la registrazione negli Stati Uniti e in altre regioni

Le presentazioni copriranno le esperienze dei pazienti nei centri ILD rispetto alle pratiche della comunità, il carico attuale dell'IPF nell'era antifibrotica e un approccio bayesiano per il trial ELEVATE IPF.

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) anunció su participación en la CHEST 2024 Annual Meeting en Boston del 6 al 9 de octubre. La compañía presentará tres estudios relacionados con LYT-100 (deupirfenidona) para el tratamiento de fibrosis pulmonar idiopática (FPI). Estas presentaciones informarán las estrategias clínicas, comerciales y de compromiso del paciente para LYT-100.

Puntos clave:

  • Se esperan datos preliminares del ensayo de fase 2b ELEVATE IPF de LYT-100 para finales de 2024
  • Se planea un programa de desarrollo simplificado, que podría avanzar a la fase 3 dependiendo de resultados positivos y comentarios regulatorios
  • PureTech cree que ensayos exitosos de fase 2b y fase 3 podrían respaldar el registro en EE. UU. y otras regiones

Las presentaciones cubrirán las experiencias de los pacientes en centros ILD en comparación con las prácticas comunitarias, la carga continua de la FPI en la era antifibrotica y un enfoque bayesiano para el ensayo ELEVATE IPF.

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC)은 10월 6일부터 9일까지 보스턴에서 열리는 CHEST 2024 Annual Meeting에 참여한다고 발표했습니다. 이 회사는 LYT-100 (deupirfenidone)을 이용한 특발성 폐섬유화증 (IPF) 치료와 관련된 세 가지 연구를 발표할 예정입니다. 이러한 발표는 LYT-100에 대한 임상, 상업 및 환자 참여 전략을 알리는 데 도움이 될 것입니다.

주요 사항:

  • LYT-100의 2b 단계 ELEVATE IPF 시험에서 주요 데이터는 2024년 말까지 발표될 예정입니다
  • 긍정적인 결과와 규제 피드백에 따라 3단계로 진행할 수 있는 간소화된 개발 프로그램이 계획 중입니다
  • PureTech는 성공적인 2b 및 3단계 시험이 미국 및 기타 지역에서의 등록을 지원할 수 있다고 믿고 있습니다

발표는 ILD 센터와 지역 사회 관행에서의 환자 경험, 항섬유화제 시대의 IPF에 대한 지속적인 부담, ELEVATE IPF 시험을 위한 베이지안 접근법을 다룰 것입니다.

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) a annoncé sa participation à la CHEST 2024 Annual Meeting à Boston du 6 au 9 octobre. L'entreprise présentera trois études liées à LYT-100 (deupirfenidone) pour le traitement de la fibrose pulmonaire idiopathique (FPI). Ces présentations informeront les stratégies cliniques, commerciales et d'engagement des patients pour LYT-100.

Points clés :

  • Les données préliminaires de l'essai de phase 2b ELEVATE IPF de LYT-100 sont attendues d'ici fin 2024
  • Un programme de développement simplifié est prévu, pouvant avancer vers la phase 3 en fonction des résultats positifs et des avis réglementaires
  • PureTech estime que des essais réussis de phase 2b et de phase 3 pourraient soutenir l'enregistrement aux États-Unis et dans d'autres régions

Les présentations couvriront les expériences des patients dans les centres ILD par rapport aux pratiques communautaires, le fardeau continu de la FPI à l'ère antifibrotique et une approche bayésienne pour l'essai ELEVATE IPF.

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) hat seine Teilnahme an der CHEST 2024 Annual Meeting in Boston vom 6. bis 9. Oktober angekündigt. Das Unternehmen wird drei Studien zu LYT-100 (deupirfenidone) zur Behandlung von idiopathischer Lungenfibrose (IPF) präsentieren. Diese Präsentationen werden die klinischen, kommerziellen und Patientenengagement-Strategien für LYT-100 informieren.

Wichtige Punkte:

  • Die wichtigsten Daten aus der Phase 2b ELEVATE IPF-Studie zu LYT-100 werden bis Ende 2024 erwartet
  • Ein vereinfachtes Entwicklungsprogramm ist geplant, das möglicherweise abhängig von positiven Ergebnissen und regulatorischem Feedback in die Phase 3 übergehen könnte
  • PureTech ist der Ansicht, dass erfolgreiche Phase 2b- und Phase 3-Studien die Registrierung in den USA und anderen Regionen unterstützen könnten

Die Präsentationen werden die Erfahrungen von Patienten in ILD-Zentren im Vergleich zu Gemeinschaftspraktiken, die laufende Belastung der IPF im antifibrotischen Zeitalter und einen bayesianischen Ansatz für die ELEVATE IPF-Studie behandeln.

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Three presentations inform clinical, commercial and patient engagement strategies for LYT-100 for the treatment of idiopathic pulmonary fibrosis (IPF)

Topline data from the Phase 2b ELEVATE IPF trial of LYT-100 expected by the end of 2024

BOSTON--(BUSINESS WIRE)-- PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced its onsite presence at the CHEST 2024 Annual Meeting in Boston, Massachusetts, from October 6-9. The Company will deliver two oral presentations and one poster relating to LYT-100 (deupirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF) as well as the Company’s research surrounding the experiences of patients with IPF.

The data to be presented have informed the clinical and commercial strategies supporting LYT-100 as well as advocacy and patient engagement work around the management and treatment of people with IPF. Topline results from the Phase 2b ELEVATE IPF trial are expected by the end of 2024. A streamlined development program for LYT-100 is planned using the same endpoints that have supported past IPF product approvals. Pending positive clinical outcomes from the Phase 2b trial and regulatory feedback, the program is expected to advance into a Phase 3 trial. PureTech believes the results of the Phase 2b trial, together with a successful Phase 3 trial, could serve as the basis for registration in the U.S. and other geographies.

Presentation Details

Presentation Title: Comparing experiences at interstitial lung disease (ILD) centers and community practices (CP) from the perspective of people with idiopathic pulmonary fibrosis (IPF)
Session: Oral presentation
Date and Time: October 8, 2024 | 10:20-11:05am EDT

Presentation Title: Ongoing burden of idiopathic pulmonary fibrosis (IPF) in the era of antifibrotics
Session: Poster presentation
Date and Time: October 8, 2024 | 1:45-2:30pm EDT

Presentation Title: Bayesian approach for ELEVATE IPF: Randomized, double-blind, placebo-controlled trial to evaluate efficacy, safety, and dose response of deupirfenidone (LYT-100) in IPF
Session: Oral presentation
Date and Time: October 8, 2024 | 1:45-2:30pm EDT

About Idiopathic Pulmonary Fibrosis (IPF)

IPF is a rare, progressive and fatal lung disease with a median survival of 2-5 years.1 Pirfenidone is one of only two drugs approved to treat IPF, and for those patients able to tolerate treatment, it has been shown to improve survival by approximately 2.5 years compared to supportive care alone.1 However, tolerability issues with both of the standard-of-care drugs result in patients discontinuing treatment or reducing their dose. This contributes to nearly three out of every four people with IPF choosing to forego treatment with these otherwise efficacious medicines.2

About LYT-100 (Deupirfenidone)

LYT-100 (deupirfenidone) is being advanced for the treatment of conditions involving inflammation and fibrosis, including IPF. It is a deuterated form of pirfenidone that is designed to retain the beneficial pharmacology and clinically-validated efficacy of pirfenidone with a highly differentiated PK profile. LYT-100 has also demonstrated favorable tolerability across multiple clinical studies in more than 400 individuals.

Pirfenidone is one of the two standard-of-care treatments approved for IPF, along with nintedanib, both of which are efficacious but associated with significant tolerability issues. These tolerability issues result in treatment discontinuations and/or dose reductions below the FDA-approved dose, thereby limiting the effectiveness of these otherwise efficacious medicines. With LYT-100, PureTech aims to deliver better outcomes for patients by enabling individuals to maintain the same or higher pirfenidone-equivalent doses for longer. PureTech believes LYT-100 has the potential both to supplant the current standard-of-care treatments and to serve a larger market of patients who are unable to tolerate current therapies. Topline data for the global Phase 2 ELEVATE IPF trial are expected by the end of 2024.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to the LYT-100 development program and development plans, its potential benefits to patients, the timing for results from the Phase 2b clinical trial of LYT-100, the advancement of the program into a Phase 3 trial, and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

1 Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting Life Expectancy for Pirfenidone in Idiopathic Pulmonary Fibrosis. Journal of Managed Care & Specialty Pharmacy, 23(3-b Suppl), S17-S24. https://doi.org/10.18553/jmcp.2017.23.3-b.s17

2 Dempsey TM, Payne S, Sangaralingham L, Yao X, Shah ND, Limper AH. Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Jul;18(7):1121-1128

PureTech

Public Relations

publicrelations@puretechhealth.com

Investor Relations



UK/EU Media

Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

puretech@fticonsulting.com



US Media

Nichole Bobbyn

+1 774 278 8273

nichole@tenbridgecommunications.com

Source: PureTech Health

FAQ

What is PureTech presenting at the CHEST 2024 Annual Meeting?

PureTech (PRTC) is presenting three studies related to LYT-100 (deupirfenidone) for treating idiopathic pulmonary fibrosis (IPF) at the CHEST 2024 Annual Meeting. These include two oral presentations and one poster presentation.

When are the topline results from PureTech's Phase 2b ELEVATE IPF trial expected?

The topline results from PureTech's (PRTC) Phase 2b ELEVATE IPF trial of LYT-100 are expected by the end of 2024.

What is PureTech's development plan for LYT-100 after the Phase 2b trial?

PureTech (PRTC) plans a streamlined development program for LYT-100, potentially advancing to a Phase 3 trial pending positive clinical outcomes from the Phase 2b trial and regulatory feedback.

What topics will PureTech's presentations at CHEST 2024 cover?

PureTech's (PRTC) presentations at CHEST 2024 will cover patient experiences at ILD centers vs. community practices, the ongoing burden of IPF in the antifibrotic era, and a Bayesian approach for the ELEVATE IPF trial of LYT-100.

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