Sanofi halts tolebrutinib trial recruitment

French drugmaker Sanofi (Euronext: SAN) has paused recruitment for its global tolebrutinib Phase III trials following guidance from the independent Data Monitoring Committee (iDMC), resulting in an almost 2% drop in its share price.

The decision follows the US Food and Drug Administration's (FDA) decision to issue a partial clinical hold for Phase III studies of tolebrutinib. Multiple health authorities outside the USA have permitted tolebrutinib studies to continue recruitment following adjustments to the protocol that reduce enrollment of patients with pre-existing liver risk factors but Sanofi has said it will respect the iDMC’s recommendation and will pause recruitment globally for those trials still undergoing active recruitment.

The Paris-based company has therefore paused the Hercules trial in non-relapsing secondary progressive multiple sclerosis (MS), the Perseus study in primary progressive MS and URSA in myasthenia gravis.