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Sanofi (NASDAQ:SNY) announced Tuesday that rilzabrutinib, an oral therapy for an autoimmune blood disorder called immune thrombocytopenia (ITP), reached the primary endpoint in a Phase 3 trial.
The study, named LUNA 3, enrolled adults and adolescents with persistent or chronic ITP who had been unresponsive to prior therapy.
They received rilzabrutinib 400 mg or placebo over a 12- to 24-week period, followed by a 28-week open-label phase and a 4-week follow-up.
As for LUNAR 3’s primary goal related to platelet response, a significantly higher percentage of patients on rilzabrutinib indicated platelet counts at or above 50,000/μL for at least eight weeks during the initial treatment period compared to those on placebo.
Safety data were in line with prior findings related to rilzabrutinib, a Bruton’s tyrosine kinase inhibitor targeted at immune-mediated diseases such as asthma, in addition to ITP.
Sanofi (SNY) expects to present detailed data from LUNAR 3 at a medical congress later this year. The adolescent section of the study is currently ongoing, with recruitments underway.
The French drugmaker added rilzabrutinib to its pipeline with its $3.7B acquisition of Principia Biopharma in 2020.