PRN2246

1st Relapsing MS Patient Enrolls in Phase 3 Trial of Oral SAR442168

A first person has enrolled inĀ Sanofiā€™s Phase 3 trial evaluatingĀ SAR442168, an oral BTK inhibitorĀ intended to treat relapsing forms of multiple sclerosis (MS), Sanofiā€™s partner, Principia Biopharma, announced. ā€œWe are delighted that Sanofi has initiated ā€¦ [this] trial in patients with relapsing MS,ā€ Roy Hardiman, chief…

Sanofi and Principia Join to Develop Potential B-Cell-targeting Oral MS Treatment

Sanofi Genzyme and Principia BiopharmaĀ 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 Brutonā€™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 toĀ design and develop better and safer therapies based on oral small molecules. The company uses its proprietaryĀ Tailored Covalency technologyĀ 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.