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

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 (BTK), 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.

“The agreement allows Principia to maximize the BTK opportunity in neurology with a strong partner for PRN2246 while focusing internal resources on our lead BTK inhibitor in another therapeutic area,” Martin Babler, chief executive officer of Principia, said in a press release.

“PRN2246 is a blood brain barrier crossing, highly potent BTK inhibitor, that we believe is especially well suited for the treatment of MS and other neurological disorders” Babler added.

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.