Phase III SPI2 trial of MD 1003 fails to meet endpoints in multiple sclerosis.- MedDay Pharma
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The FDA has placed Phase III studies of tolebrutinib in multiple sclerosis (MS) and myasthenia gravis on partial clinical hold. As a result, new enrollment in the United States (U.S.) is paused, and participants in the U.S. who have been in the trial for fewer than 60 days shall suspend study drug. Importantly, U.S. participants who have completed at least 60-days in the trial should continue treatment.
Bristol Myers Squibb announced new data on COVID-19 vaccine responses in participants treated with Zeposia (ozanimod) from the ongoing Phase III DAYBREAK open-label extension (OLE) study in relapsing multiple sclerosis.
Bristol Myers Squibb announced new post-hoc analyses from the Zeposia (ozanimod) Phase III DAYBREAK open-label extension (OLE) and Phase III SUNBEAM trials, showing early Zeposia use demonstrated cognitive benefits in people with relapsing multiple sclerosis (MS), with the greatest effect seen in people with high thalamic volume (TV), supporting an association between preserved brain volume (BV) and improved long-term cognitive outcomes.