August 19, 2020 News by Joana Carvalho, PhD Sanofi to Acquire Principia Biopharma in $3.6 Billion Transaction In a $3.68 billion transaction, Sanofi is preparing to acquire Principia Biopharma, a biopharmaceutical company focused on the development of therapies for disorders caused by dysregulation of the immune system, including multiple sclerosis (MS). The decision was unanimously approved by the board of directors of…
June 25, 2020 News by Joana Carvalho, PhD 1st Relapsing MS Patient Enrolls in Phase 3 Trial of Oral SAR442168 A first person has enrolled inĀ Sanofiās Phase 3 trial evaluatingĀ SAR442168, an oral BTK inhibitorĀ intended to treat relapsing forms of multiple sclerosis (MS), Sanofiās partner, Principia Biopharma, announced. āWe are delighted that Sanofi has initiated ā¦ [this] trial in patients with relapsing MS,ā Roy Hardiman, chief…
May 4, 2020 Columns by Ed Tobias MS News that Caught My Eye Last Week: Diagnosis by Antibody, Ocrevus After 6 Years, Telemedicine, New DMT Pill New Nanosensor May Help to Diagnose MS at Early Stages My neurologist likes to say that “brain is time.” The sooner MS is treated the more time you can buy before the brain begins to deteriorate and MS symptoms appear. Being able to diagnose MS sooner means earlier treatment.
April 24, 2020 News by Marisa Wexler, MS Sanofi’s BTK Inhibitor Seen to Effectively Reduce Brain Lesions in Phase 2 Trial 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…
April 20, 2020 News by Marisa Wexler, MS Sanofi to Detail Trial Results of Oral Relapsing MS Therapy Online on Thursday Sanofi will host an online science session to present results of a Phase 2b clinical trial testing the safety and efficacy of its investigational, oral BTK inhibitor SAR442168 in people with multiple sclerosis (MS). The virtual session, owing to the cancellation of the American Academy…
February 7, 2020 News by Marisa Wexler, MS Mayzent Approved in Europe as First Oral Treatment for Active Secondary Progressive MS The experimental BTK inhibitor SAR442168 showed an acceptable safety profile and met its primary endpoint ā a significant reduction in the number of new lesions visible on a brain imaging scan ā in a Phase 2 trial in people with multiple sclerosis (MS), study results show. SAR442168,…
May 24, 2019 News by Vijaya Iyer, PhD First Patient Dosed in Phase 2B Trial Testing SAR442168 Therapeutic Candidate for RRMS 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,Ā in collaboration withĀ Sanofi Genzyme, for MS and other central nervous…
August 2, 2018 News by Alice MelĆ£o, MSc Potential B-cell Targeting Oral MS Treatment, PRN2246, Shows Ability to Reach Brain in Phase 1 Study Results from a first-in-human study assessing the safety and early activity of PRN2246Ā 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…
November 13, 2017 News by Patricia Silva, PhD 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 Brutonās 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.