Biogen has launched the Phase II AFFINITY clinical trial of its investigational candidate opicinumab in patients suffering from relapsing multiple sclerosis (MS).
Opicinumab is a human monoclonal antibody designed to target leucine rich repeat and immunoglobin-like domain-containing protein 1 (LINGO-1).
The multi-centre, randomised, double-blind, placebo-controlled Phase II trial will assess opicinumab in 240 patients who are adequately controlled with anti-inflammatory disease-modifying therapy (DMT).
AFFINITY will investigate opicinumab as an add-on therapy, and will compare to DMT alone.
The target population for the AFFINITY trial was identified during analysis in a previous Phase II trial, SYNERGY, which showed potential response for the particular patient group.
Biogen Research & Development executive vice-president Michael Ehlers said: “As part of our long-standing commitment to the MS community, Biogen remains dedicated to advancing the treatment of MS and continues to pursue next-generation research to understand the therapeutic potential of repairing damage caused by the disease.
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“The SYNERGY data provide intriguing evidence that opicinumab, which has demonstrated remyelination properties in a previous Phase II study, may have a treatment effect in certain patients.”
During SYNERGY, opicinumab is reported to have demonstrated an enhanced clinical effect in participants who had the disease for shorter periods of time.
The primary endpoint of AFFINITY will be overall response score (ORS), an integrated measurement of improvement and worsening of disability over time.
Founded in 1978, Biogen develops medicines for various neurological conditions such as MS, Alzheimer’s disease, dementia, movement and neuromuscular disorders, pain, neuropsychiatry and acute neurology.