Protagonist and Takeda Announce ASCO Plenary Presentation Highlighting Full 32-Week Results from Phase 3 VERIFY Study of Rusfertide, Showing Reductions in Phlebotomy, Improved Hematocrit Control in Polycythemia Vera

• Rusfertide plus current standard of care more than doubled clinical response rates across high- and low-risk PV groups, significantly reducing phlebotomy eligibility compared to placebo plus current standard of care, which was the primary endpoint
• All key secondary endpoints met with statistical significance, including a nearly three-fold reduction in the proportion of patients requiring phlebotomy and a four-fold improvement in hematocrit control in rusfertide arm compared to placebo arm, as well as improvements in patient-reported outcomes
• No serious adverse events considered related to rusfertide were reported
• Rusfertide has received Orphan Drug designation and Fast Track designation from the U.S. FDA

NEWARK, Calif. & OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announced detailed results from the Phase 3, randomized, placebo-controlled VERIFY study evaluating rusfertide in patients with polycythemia vera (PV), which met the primary and all key secondary endpoints. The data will be presented as a late-breaking oral presentation at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session (LBA3) at 2:09 pm CDT today.

PV is characterized by overproduction of red blood cells (erythrocytosis), which may increase blood viscosity, or thickness, potentially resulting in life threatening thrombotic events such as stroke, deep vein thrombosis and pulmonary embolism. People with PV can experience burdensome symptoms, including severe fatigue, difficulty in concentrating, night sweats and pruritus, which may negatively impact their daily functioning and quality of life. Hematocrit is the ratio of red blood cells to total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of