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Protagonist Therapeutics Announces Plenary Presentation on VERIFY Phase 3 Study with Rusfertide at ASCO 2025

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Protagonist Therapeutics (PTGX) announced that results from its VERIFY Phase 3 study of Rusfertide for treating Polycythemia Vera (PV) will be presented at the ASCO Annual Meeting Plenary Session. The presentation will be delivered by Dr. Andrew T. Kuykendall from Moffitt Cancer Center on June 1, 2025, at 2:09 PM CDT in McCormick Place, Hall B1.

The VERIFY study is a double-blind, placebo-controlled Phase 3 clinical trial evaluating Rusfertide's effectiveness in PV treatment. The selection for a plenary presentation at ASCO, scheduled for May 30 - June 3, 2025, represents a significant platform for sharing these important clinical findings.

Protagonist Therapeutics (PTGX) ha annunciato che i risultati del suo studio VERIFY di Fase 3 su Rusfertide per il trattamento della Policitemia Vera (PV) saranno presentati durante la Sessione Plenaria del ASCO Annual Meeting. La presentazione sarà tenuta dal Dott. Andrew T. Kuykendall del Moffitt Cancer Center il 1° giugno 2025 alle 14:09 CDT presso il McCormick Place, Sala B1.

Lo studio VERIFY è una sperimentazione clinica di Fase 3, in doppio cieco e controllata con placebo, che valuta l’efficacia di Rusfertide nel trattamento della PV. L’inclusione della presentazione plenaria all’ASCO, in programma dal 30 maggio al 3 giugno 2025, rappresenta un’importante occasione per condividere questi dati clinici rilevanti.

Protagonist Therapeutics (PTGX) anunció que los resultados de su estudio VERIFY de Fase 3 sobre Rusfertide para el tratamiento de la Policitemia Vera (PV) serán presentados en la Sesión Plenaria del ASCO Annual Meeting. La presentación será realizada por el Dr. Andrew T. Kuykendall del Moffitt Cancer Center el 1 de junio de 2025 a las 2:09 PM CDT en McCormick Place, Sala B1.

El estudio VERIFY es un ensayo clínico de Fase 3, doble ciego y controlado con placebo, que evalúa la eficacia de Rusfertide en el tratamiento de la PV. La selección para una presentación plenaria en ASCO, programada del 30 de mayo al 3 de junio de 2025, representa una plataforma importante para compartir estos datos clínicos relevantes.

Protagonist Therapeutics (PTGX)Polycythemia Vera (PV) 치료를 위한 Rusfertide의 VERIFY 3상 연구 결과가 ASCO 연례회의 총회에서 발표될 예정임을 발표했습니다. 발표는 2025년 6월 1일 오후 2시 9분 CDT에 Moffitt Cancer Center의 Andrew T. Kuykendall 박사가 McCormick Place, Hall B1에서 진행합니다.

VERIFY 연구는 이중 맹검, 위약 대조 3상 임상시험으로, PV 치료에서 Rusfertide의 효과를 평가합니다. 2025년 5월 30일부터 6월 3일까지 예정된 ASCO 총회에서 총회 발표로 선정된 것은 중요한 임상 결과를 공유할 수 있는 중요한 기회입니다.

Protagonist Therapeutics (PTGX) a annoncé que les résultats de son étude VERIFY de phase 3 sur Rusfertide pour le traitement de la Polycythémie Vraie (PV) seront présentés lors de la séance plénière du ASCO Annual Meeting. La présentation sera faite par le Dr Andrew T. Kuykendall du Moffitt Cancer Center le 1er juin 2025 à 14h09 CDT au McCormick Place, Hall B1.

L’étude VERIFY est un essai clinique de phase 3 en double aveugle, contrôlé par placebo, évaluant l’efficacité de Rusfertide dans le traitement de la PV. La sélection pour une présentation plénière à l’ASCO, prévue du 30 mai au 3 juin 2025, constitue une plateforme importante pour partager ces résultats cliniques majeurs.

Protagonist Therapeutics (PTGX) gab bekannt, dass die Ergebnisse seiner VERIFY Phase-3-Studie zu Rusfertide zur Behandlung der Polycythaemia Vera (PV) auf der Plenarsitzung des ASCO Annual Meeting vorgestellt werden. Die Präsentation hält Dr. Andrew T. Kuykendall vom Moffitt Cancer Center am 1. Juni 2025 um 14:09 Uhr CDT im McCormick Place, Halle B1.

Die VERIFY-Studie ist eine doppelblinde, placebokontrollierte Phase-3-Studie, die die Wirksamkeit von Rusfertide bei der Behandlung von PV bewertet. Die Auswahl für eine Plenarpräsentation auf der ASCO, die vom 30. Mai bis 3. Juni 2025 stattfindet, bietet eine bedeutende Plattform zur Vorstellung dieser wichtigen klinischen Ergebnisse.

Positive
  • Selection for ASCO Plenary Session indicates high-impact clinical results
  • Phase 3 trial completion represents significant milestone in drug development
Negative
  • None.

NEWARK, CA / ACCESS Newswire / April 23, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced that an abstract was accepted for presentation at the Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30 - June 3, 2025.

Presentation Details:

Presenting Author: Andrew T. Kuykendall, M.D. (Moffitt Cancer Center)

Title: Results From VERIFY, a Phase 3, Double-Blind, Placebo (PBO)-Controlled Study of Rusfertide for Treatment of Polycythemia Vera (PV)

Abstract: LBA3

Session Name: Plenary Session
Session Date: Sunday, June 1, 2025
Presentation Time: 2:09 PM - 2:21 PM CDT
Location: McCormick Place, Hall B1

About Protagonist

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA potentially in 2025. Icotrokinra (formerly, JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to J&J Innovative Medicines ("JNJ"), formerly Janssen Biotech, Inc. Following icotrokinra's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, oral hepcidin program, and oral obesity program.

More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at https://www.protagonist-inc.com/.

Investor Relations Contact

Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577

Media Relations Contact

Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1

SOURCE: Protagonist Therapeutics



View the original press release on ACCESS Newswire

FAQ

What are the key findings from Protagonist's VERIFY Phase 3 trial of Rusfertide for PV treatment?

The results of the VERIFY Phase 3 trial will be presented at ASCO's Plenary Session on June 1, 2025. The specific findings have not been disclosed in the press release.

When and where will Protagonist (PTGX) present the VERIFY Phase 3 Rusfertide data?

The VERIFY Phase 3 data will be presented on June 1, 2025, at 2:09 PM CDT during ASCO's Plenary Session at McCormick Place, Hall B1.

What type of study is the VERIFY trial for PTGX's Rusfertide?

VERIFY is a Phase 3, double-blind, placebo-controlled study evaluating Rusfertide for the treatment of Polycythemia Vera (PV).

Who will present Protagonist's VERIFY Phase 3 results at ASCO 2025?

Dr. Andrew T. Kuykendall from Moffitt Cancer Center will present the VERIFY Phase 3 results at ASCO 2025.
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