First Patient Enrolled in Biogen’s Phase 3b MS Study

The first patient has been enrolled in a global Phase 3b study evaluating the efficacy and safety of extended interval dosing (EID; every six weeks) for natalizumab compared to standard interval dosing (SID) in patients with relapsing multiple sclerosis (MS), Biogen Inc. (Nasdaq: BIIB) announced. Currently commercialized under the brand name TYSABRI^®, natalizumab 300 mg dosed every four weeks is the only approved dosing regimen.

The new study, NOVA (NCT03689972), is a two-year, prospective, randomized, interventional, controlled, open-label, rater-blinded, international Phase 3b study that will assess the efficacy, safety and tolerability of six-week natalizumab dosing intervals in people with relapsing-remitting MS. Patients who switch to EID after one year of treatment with natalizumab SID will be evaluated in relation to patients receiving continued SID treatment. The study will enroll approximately 480 patients worldwide. The primary endpoint is the number of new or newly enlarging T2 hyperintense lesions at week 48.

“For more than a decade, natalizumab has been considered a highly effective treatment option for patients with relapsing forms of MS,” said Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen. “The NOVA study may generate valuable data that we hope will answer questions for the scientific community about the efficacy of natalizumab when its dosing schedule is extended to every six weeks, and in conjunction with prior safety analyses, may inform on the drug’s benefit-risk profile.”

NOVA was initiated following analyses that showed that EID was associated with a significant reduction in the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. The pre-specified, retrospective analysis of the U.S. TOUCH (TYSABRI^®Outreach: United Commitment to Health) REMS program examined the impact of EID as compared to SID on the risk of PML, and the NOVA study aims to assess the efficacy of EID natalizumab to further evaluate the drug’s benefit-risk profile.

https://globenewswire.com/news-release/2019/01/03/1680036/0/en/First-Patient-Enrolled-in-Biogen-s-Phase-3b-Study-to-Evaluate-Extended-Interval-Dosing-EID-with-Natalizumab-in-Multiple-Sclerosis.html