Principia Biopharma doses first patient in Phase 2b MS trial


Principia Biopharma (NASDAQ:PRNB) has dosed the first patient in its Phase 2b clinical trial of SAR442168 in patients with relapsing multiple sclerosis (MS).

Neuroinflammation and an increase in the number of B cells in the brain are believed to play an important role in the pathology of MS. SAR442168 is a Bruton’s tyrosine kinase (BTK) inhibitor that penetrates the blood-brain barrier and modulates immune cell function in the brain.

The Phase 2b clinical trial will enroll some 120 MS patients to evaluate the dose response of SAR442168, administered once daily.

“One challenge in developing medicines for CNS disorders has been achieving sufficient blood–brain barrier penetration,” Martin Babler, Principia’s president and CEO, said in a statement.

“We are very enthusiastic about the potential of our CNS-penetrating BTK inhibitor, especially because in a Phase 1 clinical trial, we demonstrated exposure of SAR442168 in the CNS as well as BTK occupancy in peripheral blood,” he added.

SAR442168 is being developed in partnership with Sanofi, who will conduct the Phase 2b trial and any future development. The dosing of the first patient in this trial triggers Sanofi’s $30-million milestone payment to Principia.

Abby Hardy