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Stephen Krieger, MD Assistant P rofessor of Neurology and Medical Director

Laquinimod , a Once-Daily Oral Drug in Development for The Treatment of Relapsing–Remitting Multiple Sclerosis. Scott S. Zamvil , MD, PhD Professor of Neurology Department of Neurology University of California, San Francisco San Francisco, CA.

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Stephen Krieger, MD Assistant P rofessor of Neurology and Medical Director

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  1. Laquinimod, a Once-Daily Oral Drug in Development for The Treatment of Relapsing–Remitting Multiple Sclerosis • Scott S. Zamvil, MD, PhD • Professor of Neurology • Department of Neurology • University of California, SanFrancisco • San Francisco, CA Stephen Krieger, MD Assistant Professor of Neurology and Medical Director The Corinne Goldsmith Dickinson Center for Multiple Sclerosis Icahn School of Medicine at Mount Sinai New York, NY

  2. Laquinimod: Overview • Oral therapy • Small molecule: a quinolone-carboxamide • Half-life approximately 70 hours • Dual action: • Within peripheral immune system • Within central nervous system (CNS) • Activity in CNS is relevant to disability • Studied initially in autoimmune encephalomyelitis (EAE) model in two modes • Prevention • Established disease

  3. ALLEGRO and BRAVO • Phase III trials in relapsing-remitting MS • Laquinimod 0.6 mg vs placebo • Primary endpoint = reduction in relapse rate • ALLEGRO: primary endpoint met • BRAVO: primary endpoint not met • Both ALLEGRO and BRAVO showed greater efficacy for reducing disability progression and atrophy than for reducing relapse rate • Unique observation because all other MS drugs have shown greater efficacy for relapse rate

  4. Laquinimod and Atrophy • Animal model • Laquinimod given after the onset of disease (ie, the progressive phase) prevents axonal transection • Human trials • Laquinimod has shown effect on accumulation of atrophy

  5. CONCERTO Trial • Ongoing phase III trial in relapsing-remitting MS • Approximately 1800 patients randomized 1:1:1 • Laquinimod 0.6 mg • Laquinimod 1.2 mg • Placebo • Primary endpoint = disability progression • The hope is that the higher dose will significantly reduce disease progression compared with the lower dose • ClinicalTrials.gov number NCT01707992

  6. Laquinimod: Areas of Future Study • Combination therapy • Pair with disease-modifying therapy that has strong efficacy in relapse rate reduction • Draw on lessons learned in SENTINEL and CombiRx • Progressive MS • Trial endpoints of disability progression and atrophy are particularly relevant for progressive MS • ALLEGRO and BRAVO showed efficacy of laquinimod in patients who progressed without relapse • Area of unmet need

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