Sanofi Announces Phase III LUNA 3 Trial Success for Rilzabrutinib in Immune Thrombocytopenia, Plans NDA Submission

On April 23, Sanofi announced the Phase III trial of its investigational BTK inhibitor Rilzabrutinib (SAR444671/PRN-1008) for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP).LUNA 3 Study Meets Primary Endpoint.

Sanofi plans to by the end of this yearFrontTo FDA SubmissionRilzabrutinib TheMarketing Application。

Source: Sanofi Official Website

Rilzabrutinib isSanofi AcquisitionPrincipia Biopharma product obtained in ChinaOral, reversible, covalent BTK inhibitor.

The LUNA 3 study aims to evaluate the efficacy and safety of Rilzabrutinib versus placebo in previously treated adult and adolescent patients with persistent or chronic ITP.

Double-blind treatment periodContinued for 12-24 weeks, patients received Rilzabrutinib (400 mg; twice daily) or placebo.Placebo treatment, followed by 28 weeks of open-label treatment, and then a 4-week safety follow-up period or long-term extension study. The primary endpoint of the study was the proportion of patients achieving a durable platelet response (i.e., without rescue therapy, patients had platelet counts ≥ 50,000/μL for at least 8 weeks during the last 12 weeks of the 24-week double-blind treatment period). The baseline platelet count of the patients was 15,000/μL (normal range: 150,000–450,000/μL).

The adult subgroup portion has been completed, and the results show that the primary endpoint was met. The proportion of patients in the Rilzabrutinib group achieving a sustained platelet response was significantly higher than in the placebo group, with clinically and statistically significant data.InIn terms of safety, the safety profile of Rilzabrutinib was consistent with previous studies.Detailed ResultsThe result will be announced onMedical conferences thereafterPublished above. TheAdolescentsThe subgroup is still ongoing and recruiting participants.。

Apart from the ITP indication, Sanofi is also exploring the therapeutic potential of Rilzabrutinib in other immune diseases, includingChronic Spontaneous Urticaria,IgG4-related diseases, etc.

Rilzabrutinib Global R&D Project Progress Gantt Chart

Source: Insight Database Web Version