Laquinimod – new promising treatment of multiple sclerosis

Laquinimod is a once-daily novel oral immunomodulatory agent developed as a disease modifying treatment for multiple sclerosis, MS, which Active Biotech has licensed to Teva Pharmaceutical Industries Ltd. (2004).

Multiple sclerosis

Multiple sclerosis (MS) is a chronic, progressive disease affecting the central nervous system. It is described as an autoimmune disease since it belongs to a large group of diseases that cause the body’s immune defense system to attack healthy areas of the body as if they were foreign bodies. MS can cause anything from minor symptoms for lengthy periods to severely incapacitating symptoms within a few years. Initially, MS comes in “flare-ups” with alternating periods of deterioration and stability.

The disease mainly affects young people, and more women than men; the average age of onset of the disease is about 30. The total market for MS pharmaceuticals amounted to USD 5 billion in 2005 (Cowen). Since MS patients must be on medication throughout their lifetime, an oral treatment creates a substantial advantage compared with existing products in the market, all of which must be injected.

Recent research

The Allegro study (assessment of oral laquinimod in preventing progression of multiple sclerosis), which is a global, pivotal, double-blind, Phase III study designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo in the treatment of RRMS, has been in progress since November 2007. The Allegro study will enroll approximately 1,000 patients and the treatment administered is a 0.6 mg tablet of laquinimod once a day or placebo. The study is scheduled to continue for 24 months with the possibility to extend to 30 months.

A second pivotal Phase III study, Bravo (benefit-risk assessment of Avonex® and laquinimod), which is a global, multi-center, randomized, placebo-controlled study with parallel groups encompassing approximately 1,200 patients who are to be studied for 24 months, has been initiated. The study will compare the effect of once-daily orally administered laquinimod 0.6 mg with placebo and also provide risk-benefit data in relation to treatment with a product presently established in the market and administered by injection (Avonex®).

Information regarding the Phase III studies is published on www.TevaClinicalTrials.com and www.clinicaltrials.gov.

Teva recently presented results from two preclinical studies for the MS project laquinimod at the conference 60th Annual Meeting of the American Academy of Neurology (AAN) held on April 12-19 in Chicago, in the US. Results from these preclinical studies can help enhance understanding of laquinimod’s positive effects in patients with multiple sclerosis, MS. The complete posters are available for download under the heading "Publications".