Introduction: Multiple sclerosis (MS) is considered an autoimmune disease with inflammatory and neurodegenerative underlying processes that affect the central nervous system. The available disease-modifying therapies (DMTs) approved to treat MS have only shown partial benefit in controlling the disease progression, primarily impeding its inflammatory component, while the parenteral administration of most of these therapies has shown to affect patient compliance. Laquinimod is a promising new oral drug recently evaluated in a third phase III clinical trial that demonstrated beneficial effects in delaying disease progression and preventing brain atrophy, suggesting a potential neuroprotective effect and a favorable safety profile.
Areas covered: This is a comprehensive review covering clinical efficacy and safety data obtained from two phase III clinical trials, as well as the presumed beneficial mechanism of action, of laquinimod. This article also provides a short overview of the oral DMTs recently approved for the treatment of relapsing MS, as well as challenges that still remain to be overcome to fully control the relentless course of MS.
Conclusion: Laquinimod has been shown to have a novel immunomodulatory and potential neuroprotective mechanism of action as suggested from animal models and in vitro experimental data. Phase III clinical trials ALLEGRO (Clinicaltrials.gov #NCT00509145) and BRAVO (Clinicaltrials.gov #NCT00605215) have demonstrated clinical efficacy and tolerability, while the third phase III study is currently evaluating the safety and efficacy of laquinimod at a higher dosage. Emerging oral treatments like laquinimod will provide new options for patients to consider that can lead to better patient adherence and improved outcomes.
Keywords: Clinical trials; Disease modifying therapies; Laquinimod; Multiple sclerosis; Neurology; Neuroprotection.