Takeda and Protagonist report topline results from rusfertide’s trial

Takeda and Protagonist Therapeutics reported positive topline results from their Phase III VERIFY trial of rusfertide as an add-on treatment for polycythaemia vera (PV) in phlebotomy-dependent patients. The randomized trial met its primary endpoint, with 77% of patients in the therapy arm achieving an absence of phlebotomy eligibility in weeks 20-32, compared to 33% in the placebo group.

Key secondary endpoints were also met, including a significant reduction in the number of phlebotomies. Patients in the therapy group averaged 0.5 phlebotomies in 32 weeks, while those in the placebo group averaged 1.8. Rusfertide’s safety profile was consistent with previous studies, with mild injection site reactions being the most common adverse events.

This outcome may reduce the treatment burden for PV patients, improving their quality of life by decreasing the need for frequent phlebotomies. Protagonist will receive a $25 million milestone payment following the successful trial results.

13-03-2025

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