- Results from the Phase 1/2 dose-finding study evaluating Sanofi SA's (NASDAQ:SNY) rilzabrutinib in adults with heavily pre-treated immune thrombocytopenia (ITP) were published in the New England Journal of Medicine.
- Results demonstrate that rilzabrutinib treatment led to a rapid and durable increase in platelet count and supports an acceptable safety profile.
- Sanofi is investigating the safety and efficacy of twice-daily rilzabrutinib (400 mg) for adults and adolescents with chronic ITP in the ongoing Phase 3 clinical study LUNA 3.
- The Phase 1/2 study evaluated rilzabrutinib in 60 patients, with a primary endpoint of at least two consecutive platelet counts of ≥50×109/L and an overall platelet count increase of ≥20×109/L from the start of treatment without requiring rescue medication.
- Overall, 24 of 60 people enrolled in the study at any dose achieved the primary endpoint.
- Of the 45 people who initiated rilzabrutinib at 400 mg twice daily, 18 met the primary endpoint.
- Median time to a first platelet count of at least 50×109/L was rapid at 11.5 days, maintained in patients with primary platelet response for a mean of 65% of weeks during the 24-week treatment period.
- There were no grade 3 or higher treatment-related adverse events or serious adverse events.
- Price Action: SNY shares are down 1.75% at $55.71 during the market session on the last check Thursday.
