Feb 6, 2020: Its primary endpoint was reached by the Sanofi Phase 2b trial evaluating its investigational BTK (Bruton’s tyrosine kinase) inhibitor (SAR442168), an oral brain penetrating, selective small molecule.
In the trial, as measured by the magnetic resonance imaging (MRI), SAR442168 significantly reduced disease activity associated despite multiple sclerosis (MS). With no new safety results, SAR442168 had been well accepted.
The BTK inhibitor is deliberate to modulate both adaptive (B-cell activation) and innate (CNS microglial cells) immune cells linked to neuroinflammation in the brain and spinal cord.Â
Four Phase 3 studies will investigate the effects of SAR442168 on rates of MS relapse, the progression of the disability and underlying damage to the central nervous system.Â
Phase 3 trials in both recurrent and progressive forms of MS are scheduled to be launched in mid-year.
In the US and Europe, there are about 1.2 million people diagnosed with MS, an impulsive, chronic disease that attacks the central nervous system.
regardless of the current treatments, many MS patients continue to accumulate disability, and one in four MS patients suffer from progressive forms of the disease with the limited or no treatments available. The global market for MS therapies exceeds €20 billion annually. Comprehensive results from the Phase 2b trial with advanced imaging endpoints will be presented at an upcoming medical meeting.
About the Phase 2b Trial: The Phase 2b study was a 12 week ranging, randomized, double-blind, week dose placebo-controlled trial assessing SAR442168 in patients with chronic MS.
About SAR442168: SAR442168 is an investigational, oral, brain-penetrator, selective small-molecule inhibitor of BTK. SAR442168 works by  BTK binding as well as cerebrospinal fluid exposure in the Phase 1 studies.
The effectiveness and safety of SA442168 have not been reviewed by any regulatory authority.
Sanofi secured global rights under a license agreement with Principia Biopharma, Inc., to develop and sell SAR442168. For more information on SAR442168 clinical trials, please visit www.clinicaltrials.gov.
https://www.sanofi.com/en/media-room/press-releases/2020/2020-02-06-07-00-00
