Sanofi's Rilzabrutinib Data In Autoimmune Blood Disorder Published In New England Journal of Medicine

Results from the Phase 1/2 dose-finding study evaluating Sanofi SA's 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.
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