With Gilenya generics looming, Novartis’ siponimod team buffs up the MS data package being prepped for the FDA

Researchers for Novartis $NVS turned up at the 70th American Academy of Neurology annual meeting in LA Friday to polish up their pivotal data package for their would-be MS blockbuster siponimod.

Bruce Cree

In the latest update on Phase III results, they noted that while there was no benefit in memory, patients in the drug arm did get a significant boost on cognitive processing speed compared to placebo (p=0.0004). And they have data to demonstrate that there’s a significant reduction in risk of disease progression among non-relapse patients that grows from a sustained level of 14%-to-20% at three months to 29%-to-33% at six months.

Why is that important?

“Siponimod’s beneficial effect on preventing disability progression, independent from its reduction in relapse frequency, demonstrates that patients with secondary progressive MS could benefit from this treatment,” said study steering committee member Bruce Cree. “This is very exciting because many people diagnosed with relapsing-remitting MS, the most common form of the disease, will ultimately transition to SPMS, where without effective new therapies, they experience gradual worsening of disability despite infrequent relapses.”

Danny Bar-Zohar

A month ago we were told investigators tracked a significant 21% reduction in the risk of disease progression among patients taking siponimod (BAF312) after three months, making the primary goal of the study. The full results published in The Lancet provided a more complete portrait. 

Secondaries in the study demonstrated the therapy:

  • Slowed the rate of brain volume loss by 23%.
  • Limited the increase of T2 lesion volume by a mean of about 80%.
  • Reduced the annual relapse rate by 55%.
  • And raised the bar on reducing disease progression to 26% at month 6.

“This is pretty much the first and only study in secondary progressive MS that showed meaningful results,” Novartis’ Danny Bar-Zohar, the global head of neuroscience development at Novartis, told me last month. The drug works by binding to the S1P1 sub-receptor on lymphocytes, which prevents them from penetrating the central nervous system.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
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Atlas Venture Cambridge, MA

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