Opicinumab, an investigative treatment aiming to promote remyelination in relapsing multiple sclerosis (MS) patients, will be tested in a new clinical trial — having failed at an earlier effort, but having shown promise enough in particular patients to be worth a closer look.
In fact, the new AFFINITY study “is only possible because we learned a lot from the SYNERGY study,” Sarah Sheikh, medical director for Clinical Development at Biogen, said in an interview with Multiple Sclerosis News Today.
Sheikh spoke about opicinumab, an anti-LINGO antibody being developed by Biogen to promote re-myelination in the central nervous system of people with MS, on the first day of the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris that runs through Oct. 28.
Opicinumab failed to reach its primary goal in the Phase 2 SYNERGY trial (NCT01864148) earlier this year, but data indicated that a specific patient population did respond to the treatment, showing less disability.
For this reason, Biogen launched AFFINITY, a Phase 2b trial (NCT03222973) evaluating opicinumab as an add-on therapy at five U.S. test sites. It expects to enroll 240 relapsing MS patients on a stable dose of various disease-modifying therapies, which they will continue to use during the 72-week study.
Its primary endpoint is overall response score (ORS) — a four-component measure that takes into account changes in disability over time — in patients given the add-on therapy and those given placebo.
The fixed dose of opicinumab that will be used in AFFINITY — 750 mg — came from the results seen in the SYNERGY study concerning an optimal dose, Sheikh said. Opicinumab will be delivered intravenously in a once monthly infusion.
“In addition to the dose … the SYNERGY study has allowed us to identify a patient population that might particularly benefit from opicinumab” she added, referring to the subgroup of patients who responded to treatment in the initial study.
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