Experimental Medications: Monoclonal Antibodies
- 750 mg given via intravenous (IV) infusion
- Being studied in RMS and SPMS
Opicinumab is a human monoclonal antibody that targets LINGO-1, a protein that suppresses the redevelopment of axons (brain cells that send functional information throughout the body) and re-formation of myelin sheaths (fibers that protect the axons). Axons and myelin sheaths are lost or damaged in patients with MS, leading to loss of physical and cognitive function. By blocking LINGO-1, opicinumab is formulated to promote regeneration of axons and myelin.55
The Phase II, double-blind AFFINITY study is assessing the effectiveness of opicinumab as an add-on therapy in people with relapsing or secondary-progressive forms of MS (RMS or SPMS). Approximately 240 individuals treated with an interferon beta medication, dimethyl fumarate (Tecfidera), or natalizumab (Tysabri) will receive IV opicinumab 750 mg or placebo every four weeks for 72 weeks.
Researchers will measure overall disability improvement or worsening, as well as specific measures of physical and cognitive function. Participants entering the study have had MS for 20 years or less, and have moderate to severe disability, preserved brain function, stable disease status, and at least one relapse between four months and two years before the study.55 The estimated completion date for the study is May 2022.56
A previous Phase II trial evaluated four doses of opicinumab as an adjunct to interferon beta therapy in an MS patient group with similar characteristics. Patients who received 10 mg of opicinumab per kilogram of body weight each month saw a 65.6 percent improvement in MS disability, while those who received 30 mg/kg every four weeks improved by 68.8 percent. However, individuals who received lower and higher doses (3 mg/kg or 100 mg/kg) did not see significant improvement compared with those in the placebo group. In all, 334 participants completed the study.57