VERIFY Study Results - The Phase 3 VERIFY study met its primary endpoint, with 76.9% of patients in the rusfertide plus current standard-of-care (CSC) group achieving a clinical response compared to 32.9% in the placebo plus CSC group (p<0.0001)[14] - Rusfertide significantly reduced the mean number of phlebotomies (PHL) from weeks 0-32, with the rusfertide group averaging 0.5 PHL compared to 1.8 PHL in the placebo group (p<0.0001)[21] - 72.8% of patients in the rusfertide group experienced freedom from phlebotomy during weeks 0-32, compared to only 21.9% in the placebo group[23] - 62.6% of patients in the rusfertide group maintained a hematocrit (Hct) level below 45% from baseline through week 32, compared to 14.4% in the placebo group (p<0.0001)[26] Symptom Improvement - Rusfertide demonstrated a statistically significant improvement in fatigue symptoms as measured by the PROMIS Fatigue SF-8a, with a LS means difference of -1.95 between the rusfertide and placebo groups at week 32 (p=0.0268)[33] - Rusfertide also showed a statistically significant improvement in the MFSAF TSS7, with a LS means difference of -1.87 between the rusfertide and placebo groups at week 32 (p=0.0239)[39] Safety and Tolerability - The most common treatment-emergent adverse events (TEAEs) in the rusfertide group were injection site reactions (55.9%) and anemia (15.9%)[46] - Discontinuation rates due to TEAEs were 5.5% in the rusfertide group and 2.7% in the placebo group[47] Commercial Potential and Partnership - Rusfertide has a peak revenue potential of $1-2 billion[53] - Protagonist Therapeutics has a partnership with Takeda for the commercialization of rusfertide, with potential milestones up to $975 million and royalty rates of 14-29% worldwide if Takeda opts out of a 50:50 US profit/loss share[59]