Sanofi advances belumosudil Phase 3 in cGVHD; H5N8 flu vaccine study recruiting

Two Sanofi trials moved forward this week, one in cell therapy and one in vaccines.

• Sanofi's Phase 3 trial of belumosudil (also known as SAR445761) for chronic graft-versus-host disease is not yet recruiting, with an estimated start of September 7, 2026. The study will compare belumosudil against best available therapy in participants at least 12 years old with cGVHD, randomized 1:1 and stratified by baseline disease severity, concomitant steroid or calcineurin inhibitor use, and number of prior therapy lines.¹ The primary endpoint is overall response rate at week 24, and the study is estimated to enroll 356 participants.¹
• Sanofi's Phase 1/2 study of an egg-based H5N8 influenza vaccine adjuvanted with Matrix-M is recruiting, with an actual start date of August 3, 2026. The trial is testing an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness² in an estimated 640 participants.²