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200 AFFINITY: opicinumab in a targeted population of MS patients
  1. Bing Zhu1,
  2. Peter A Calabresi2,
  3. Gavin Giovanonni3,
  4. Raj Kapoor4,
  5. Robert Naismith5,
  6. Hans-Peter Hartung6,
  7. Douglas L Arnold7,8,
  8. Paul Wolstencroft9,
  9. Kristina Johnson1
  1. 1Biogen, Cambridge, MA, USA
  2. 2Johns Hopkins Hospital, Baltimore, MD, USA
  3. 3Barts and The London School of Medicine and Dentistry, London, UK
  4. 4National Hospital for Neurology and Neurosurgery, London
  5. 5Washington University, St. Louis, MO, USA
  6. 6Department of Neurology, Medical Faculty, Heinrich-Heine University, Dusseldorf, Germany
  7. 7McGill University, Montreal, QC, Canada
  8. 8NeuroRx Research, Montreal, QC, Canada
  9. 9Biogen, Maidenhead
  10. 10Biogen, Cambridge, MA, USA, at the time of this study

Abstract

Introduction Opicinumab is a human monoclonal antibody against LINGO-1, a negative regulator of oligodendrocyte differentiation and axonal regeneration. The phase 2 SYNERGY study identified a patient subpopulation with a potentially enhanced response to opicinumab treatment.

Methods AFFINITY (NCT03222973) is an ongoing, randomised, double-blind, placebo-controlled phase 2 study to evaluate the efficacy/safety of opicinumab vs placebo as an add-on to disease-modifying therapies in a targeted population. Inclusion criteria include: age 18–58; relapsing multiple sclerosis (MS) with ≤20-year duration; Expanded Disability Status Scale (EDSS) score 2.0–6.0; evidence of disease activity within 24 months prior to enrolment; brain MRI criteria suggestive of low myelin content but preserved tissue integrity in pre-existing T2 lesions; stably treated ≥24 weeks with interferon-beta, dimethyl fumarate, or natalizumab. Primary endpoint is the multicomponent Overall Response Score (based on EDSS, Timed 25-Foot Walk, and 9-Hole Peg Test). Secondary endpoints will evaluate confirmed improvement in disability measures.

Results Enrolment began in September 2017 and was completed in September 2018. Participant baseline demographic, disease, and MRI characteristics will be presented.

Conclusions AFFINITY will further investigate the efficacy and safety of opicinumab in a subpopulation of MS patients.

Support: Biogen. Disclosures to be included on poster.

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