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Protagonist Therapeutics Announces Oral Presentation on Long-Term Follow-up of Rusfertide Phase 2 REVIVE Study Open Label Extension at the European Hematology Association 2024 Congress

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Protagonist Therapeutics (NASDAQ:PTGX) announced that new data from its rusfertide Phase 2 REVIVE study will be presented at the European Hematology Association (EHA) Congress scheduled for June 13-16, 2024, in Madrid, Spain. The presentation will focus on long-term results, specifically hematocrit control and therapeutic phlebotomy frequency in patients with Polycythemia Vera. Additionally, an abstract published at the event will highlight the absence of QTc prolongation in a thorough QT/QTc study with healthy subjects. Key figures involved in the presentations include Dr. Kristen M. Pettit from the University of Michigan and Nishit Modi, SVP of Clinical Pharmacology at Protagonist.

Positive
  • Presentation at a major international conference (EHA 2024) enhances visibility and credibility.
  • Long-term data from the rusfertide Phase 2 study suggests ongoing research and commitment to drug development.
  • Absence of QTc prolongation in healthy subjects indicates a favorable safety profile for rusfertide.
  • Focus on hematocrit control and reduced therapeutic phlebotomy frequency could show efficacy in treating Polycythemia Vera.
Negative
  • No financial data or revenue projections were provided, which could leave investors uncertain about financial implications.
  • The absence of concrete Phase 3 data might suggest that the drug is still far from market approval.
  • Lack of mention of any immediate plans for next-phase trials could indicate potential delays in drug development.

NEWARK, CA / ACCESSWIRE / May 14, 2024 / Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or the "Company") today announced that additional data from the rusfertide Phase 2 REVIVE open label extension study will be the focus of an oral presentation at the European Hematology Association (EHA) Congress being held in Madrid, Spain from June 13-16, 2024. There will also be a published abstract showing the absence of QTc prolongation with rusfertide based on the results from the thorough QT/QTc study conducted in healthy subjects.

EHA Presentation Details:
Oral Presentation Title: Updated Long-Term Results from the Phase 2 Revive Study Investigating the Hepcidin Mimetic Rusfertide in Polycythemia Vera Patients (Pts): Hematocrit Control and Therapeutic Phlebotomy (Tp) Frequency.
Presenter: Kristen M. Pettit, MD, Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, MI, USA.
Date and Time of Conference Session: Friday, June 14th, 2024, 14:45 - 16:00 CEST; Hall Goya 2

EHA Published Abstract Details:

Oral Presentation Title: Absence of QTc Prolongation with Rusfertide, a Hepcidin Mimetic for the Treatment of Polycythemia Vera: a Thorough QT/QTc Study in Healthy Subjects.
Lead Author: Nishit Modi, SVP of Clinical Pharmacology, Protagonist Therapeutics

About Protagonist

Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Rusfertide will be co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in January 2024. The agreement will be effective upon the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.

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

Investor Relations Contact

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

Media Relations Contact

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

SOURCE: Protagonist Therapeutics, Inc.



View the original press release on accesswire.com

FAQ

What is Protagonist Therapeutics presenting at EHA 2024?

Protagonist Therapeutics is presenting long-term results from the Phase 2 REVIVE study of rusfertide, focusing on hematocrit control and therapeutic phlebotomy frequency in Polycythemia Vera patients.

When will the Protagonist Therapeutics presentation take place at EHA 2024?

The presentation will take place on Friday, June 14th, 2024, from 14:45 - 16:00 CEST in Hall Goya 2.

What significant safety data was revealed in the QT/QTc study of rusfertide?

The thorough QT/QTc study in healthy subjects indicated the absence of QTc prolongation with rusfertide.

Who are the key presenters for Protagonist Therapeutics at EHA 2024?

Dr. Kristen M. Pettit from the University of Michigan and Nishit Modi, SVP of Clinical Pharmacology at Protagonist Therapeutics, are key presenters.

What is the main focus of the Phase 2 REVIVE study being presented?

The main focus is on hematocrit control and the frequency of therapeutic phlebotomy in patients with Polycythemia Vera.

Protagonist Therapeutics, Inc

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