Update on VERIFY patient enrollment and timing of top-line data for rusfertide in polycythemia vera .- Protagonist Therapeutics.

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 III 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 III VERIFY trial (NCT05210790) is a global Phase III 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 III study along with the REVIVE Phase II 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 III 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 II 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.

Dr. Patel continued, "We are in a very exciting phase for the Company as we anticipate a series of announcements and data disclosures in the second half of 2024 and throughout 2025, centering on our late stage partnered assets, as well as our fully owned discovery programs like Oral IL-17 antagonist, and other programs in hematology and metabolic diseases.