Teva, Active Biotech complete enrollment in phase III CONCERTO trial of laquinimod in patients with RRMS Jerusalem, Israel ,Saturday, June 27, 2015, Teva Pharmaceutical Industries Ltd., the world's largest generic medicines producer, and Active Biotech, a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer, announced that the patient enrollment for the pivotal phase III CONCERTO trial of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS) has been finalized, as well as a planned sample size re-assessment analysis of the study. CONCERTO is designed to evaluate the safety and efficacy of laquinimod (0.6mg or 1.2mg/day) with a primary endpoint of time to Confirmed Disability Progression (CDP), as measured by the Expanded Disability Status Scale (EDSS). The sample size reassessment was included as part of the protocol to confirm that the original assumptions are in line with the study and that the sample size is adequate. Based on recent agreement with FDA, under a Special Protocol Assessment (SPA) agreement, study completion will occur when either 260 events are reached or all patients complete 24 months of study treatment (whichever occurs first). CONCERTO study results are expected to be available toward mid-2017. Regulatory submission will follow study completion."We are committed to realising the full potential of laquinimod. The molecule has a unique mechanism for future treatment of MS and other neurodegenerative diseases by working directly in the central nervous system, showing promise to prevent brain atrophy and slow disability progression in these patients," said Michael Hayden, M.D., Ph.D., president of global R&D and chief scientific officer at Teva. Laquinimod is also being tested in phase II trials for the treatment of subjects with primary progressive MS and Huntington disease; two diseases for which no approved disease modifying therapies are available. Laquinimod is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), progressive MS and Huntington's disease. The global, phase III, clinical development programme evaluating laquinimod in MS includes two completed pivotal studies, ALLEGRO and BRAVO (both 0.6mg/day). A third phase III trial, CONCERTO, is currently ongoing and evaluating two doses of laquinimod (0.6mg and 1.2mg/day) in 2,199 patients for up to 24 months. The primary outcome measure is time to three-month confirmed-disability progression as measured by the Expanded Disability Status Scale (EDSS). In the ALLEGRO and BRAVO trials, adverse reactions observed included headache, abdominal pain, back and neck pain, appendicitis, and mild, asymptomatic laboratory abnormalities, including liver enzyme elevations, haematological changes and elevation of CRP or fibrinogen levels.
Laquinimod (also known as Nerventra or ABR-215062) is a tablet being developed for relapsing remitting MS by Teva and Active Biotech. It is currently in phase 3 trials, but so far has been refused a license by the EMA.
The CONCERTO trial This phase 3 study began in 2013 and will evaluate two doses of laquinimod (0.6mg and 1.2mg) in approximately 1,800 people. The trial is expected to be completed in 2018. In February 2013, Teva filed for a patent in the USA for a mixed treatment of copaxone and laquinimod. This mix would be given as an injection and has been shown in laboratory models of MS to be more effective than the current treatment.
The ARPEGGIO trial This is a phase II multicentre study that began in January 2015. The study will investigate the effect of 48 weeks of treatment with laquinimod (at two different doses) or a placebo on brain volume changes in 375 people with primary progressive MS. The study will also record progression of disability, new lesions measured by MRI and cognition.
The BRAVO trial In 2014 the results of a two year phase 3 trial were published. This study included 1,331 people with relapsing remitting MS from all over the world, and compared the effects of 0.6mg of laquinimod with interferon beta-1a (Avonex), and a placebo drug. The study did not find a statistically significant reduction in relapse rates in participants taking laquinimod compared to the placebo group. However, laquinimod did have a significant effect on reducing rates of brain shrinkage and disability progression. The study has since been extended to further evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod (0.6 mg) in people with relapsing remitting multiple sclerosis.
The ALLEGRO trial An earlier two year phase 3 trial in over 1100 people showed that a daily dose of 0.6mg of laquinimod reduced relapse rates by 23 per cent and disability progression by 36 per cent compared to a placebo.
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