Protagonist Therapeutics Provides Update on VERIFY Patient Enrollment and Timing of Top-line Data

On track to achieve 250 patient enrollment target in March 2024

Top-line data for 32-week primary endpoint expected in the first quarter of 2025

NEWARK, CA / ACCESSWIRE / March 26, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced it has randomized 241 patients in the ongoing Phase 3 VERIFY clinical trial evaluating rusfertide in polycythemia vera ("PV") as of today and expects to meet the trial's 250 patient enrollment target by the end of March 2024. Eligible patients in screening as of March 31, 2024 will be randomized by the end of April 2024. The Company expects to announce top-line data for the study's 32-week primary efficacy endpoint by the end of the first quarter of 2025.

"Currently available therapies provide suboptimal hematocrit and symptom control in patients with PV, and we believe rusfertide has the potential to meet these unmet medical needs. We are looking forward to the results of the VERIFY phase 3 study in anticipation of filing an NDA for rusfertide in 2025 together with our partner Takeda," said Arturo Molina, M.D., M.S., Protagonist's Chief Medical Officer. "We wish to thank the principal investigators and study staff for their dedication and contributions towards completing enrollment, and the patients who have agreed to participate in this important research study."

The Phase 3 VERIFY trial (NCT05210790) is a global Phase 3 randomized, double-blind, placebo-controlled trial designed to enroll approximately 250 patients. The trial evaluates the efficacy, symptom burden and safety of once-weekly, subcutaneously self-administered rusfertide in patients with uncontrolled hematocrit who are phlebotomy dependent despite standard of care treatment. The trial enrolled patients in 20 countries across North and South America, Europe, Asia and Australia. This Phase 3 study along with the REVIVE Phase 2 trial and other completed studies will comprise the clinical data package planned for NDA filing.

"2024 has been a very busy year for the rusfertide program, and we are pleased to announce our Phase 3 VERIFY trial is advancing as planned," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "Rusfertide has performed very well in the Phase 2 REVIVE study as further confirmed by the long-term follow-up data showing the durability of hematocrit control. We look forward to data from the 52-week endpoint for VERIFY including the durability of response in the first half of 2025, and potentially filing an NDA in the fourth quarter of 2025.