Principia Biopharma Inc. announced that the first patient has been enrolled in its partner Sanofi’s Phase III clinical trial of SAR 442168 in patients with relapsing multiple sclerosis (RMS). Upon dosing, Principia will be entitled to a $50 million milestone payment. SAR 442168, discovered by Principia and formerly known as PRN 2246, is a Bruton’s tyrosine kinase (BTK) inhibitor that crosses the human blood-brain barrier and modulates immune cell function in both the periphery and in the central nervous system (CNS), which shows promise for the potential treatment of CNS diseases.
About this Phase III Trial of SAR 442168 : As part of a broad Phase III clinical program in MS, Sanofi has initiated a global, randomized, double-blind efficacy and safety trial comparing SAR 442168 to teriflunomide (Aubagio) in 900 participants with relapsing forms of MS. The trial will assess efficacy of daily SAR 442168 compared to a daily dose of 14 mg teriflunomide measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS. Secondary objectives will assess efficacy of SAR 442168 compared to teriflunomide on disability progression, MRI lesions, cognitive performance and quality of life.