Date: 2012-04-19
Type of information: Presentation of results at a congress
phase: 2b
Announcement: presentation of results at the 64th annual meeting of the American Academy of Neurology (AAN)
Company: Novartis (Switzerland)
Product: siponimod (BAF312)
Action
mechanism: Siponimod is a selective modulator of the S1P receptor subtypes 1 and 5 (S1P1, -5R modulator).
Disease: multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country:
Trial details:
Latest
news: * On April 19, 2012, Novartis announced that new phase 2b data will be presented at the 64th annual meeting of the American Academy of Neurology (AAN) on its investigational compound BAF312 (siponimod), a selective modulator of the S1P receptor subtypes 1 and 5 (S1P1, -5R modulator) in its multiple sclerosis portfolio. This double-blind placebo-controlled study applied an innovative adaptive trial design to optimally describe the dose response relationship. A statistically significant dose response relationship could be established. Further, the study showed that treatment with BAF312, when compared to placebo, reduced brain MRI lesions up to 80%. Relapses were infrequent and appeared reduced with treatment (ARR for 2 mg 0.20 vs. placebo 0.58; p=0.044). Data also showed that BAF312 was generally well-tolerated with an initial dose titration. The most frequent adverse events were headache, bradycardia, dizziness and nasopharyngitis. A phase III MS program is planned to start later this year. (Stüve O. et al. BAF312, a Selective Sphingosine-1-Phosphate Receptor Modulator Improves MRI and Clinical Outcomes in Relapsing-Remitting Multiple Sclerosis (RRMS). Platform Presentation at AAN, New Orleans, April 2012)
