A first person has enrolled in Sanofi’s Phase 3 trial evaluating SAR442168, an oral BTK inhibitor intended to treat relapsing forms of multiple sclerosis (MS), Sanofi’s partner, Principia Biopharma, announced. “We are delighted that Sanofi has initiated … [this] trial in patients with relapsing MS,” Roy Hardiman, chief…

The investigational, oral BTK inhibitor SAR442168 can limit the number of new inflammatory brain lesions in people with relapsing forms of multiple sclerosis (MS), results from a Phase 2b clinical trial show. “The results of this study give hope that SAR442168 may become an important…

The experimental BTK inhibitor SAR442168 showed an acceptable safety profile and met its primary endpoint — a significant reduction in the number of new lesions visible on a brain imaging scan — in a Phase 2 trial in people with multiple sclerosis (MS), study results show. SAR442168,…

The first patient has been dosed in a Phase 2B clinical trial evaluating the safety, efficacy, and tolerability of SAR442168 in people with relapsing multiple sclerosis (MS). SAR442168, formerly known as PRN2246, is being developed by Principia Biopharma, in collaboration with Sanofi Genzyme, for MS and other central nervous…

Results from a first-in-human study assessing the safety and early activity of PRN2246 confirmed that the oral compound can reach into the brain and spinal cord. This finding adds new evidence that PRN2246 has the potential to target the immune cells that drive the inflammatory process involved in multiple sclerosis…

Sanofi Genzyme and Principia Biopharma have entered into a license agreement to advance the clinical development of PRN2246, an oral drug candidate for the treatment of multiple sclerosis and other diseases of the central nervous system. PRN2246 is an inhibitor of the Bruton’s tyrosine kinase, an enzyme encoded by the BTK gene that plays a crucial role in B-cell development and the B-cell signaling pathway. B-cells are known to be involved in the development of autoimmune diseases that affect the nervous system, including multiple sclerosis. PRN2246 is an orally available therapy designed to easily access the central nervous system (brain and spinal cord) by crossing the blood-brain barrier, and impact the signaling of immune cells and brain cells involved in autoimmunity and inflammatory processes. The drug is designed to safely and effectively modulate B-cell function without depleting these cells. A Phase 1 clinical trial is now testing the drug's safety in healthy volunteers. Under the agreement, which is expected to close shortly, Principia will grant Sanofi an exclusive, worldwide license to develop and commercialize PRN2246. Principia, in return, will receive $40 million in upfront payments from Sanofi, and future milestone payments could reach $765 million. Principia will retain the option to co-fund the treatment's Phase 3 development in exchange for other royalties in the United States. Principia has developed a novel way to design and develop better and safer therapies based on oral small molecules. The company uses its proprietary Tailored Covalency technology to develop its drug candidates, which are, according to the company's website, safer, and more selective, potent and durable than other available treatments. The terms of this licensing agreement are still subject to customary regulatory approval.