From Active Biotech's website:
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 was fully recruited in November 2008 encompassing 1,000 patients. 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 24 months study with parallel groups, was initiated in April 2008. 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®). The Bravo study was fully recruited in June 2009 encompassing 1,200 patients.
This means that more than 2,000 patients are now participating in pivotal studies for this indication. The patients will be treated over a period of two years after which laquinimod's effect on disease progression will be determined. At the end of 2010, treatment of the final patient in the first Phase III study ("Allegro") will be complete.
Laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA) in February 2009. Two global Phase III clinical studies, ALLEGRO and BRAVO, have completed enrollment and are currently ongoing, with results anticipated in [the first and third quarters of] 2011 respectively.
In September 2010, the results were presented of a 36-week active extension study evaluating two doses of laquinimod for the treatment of relapsing remitting multiple sclerosis (RRMS). The double-blind, multinational study demonstrated the sustained positive benefit/risk profile of laquinimod, which was shown to reduce Gd-enhancing (GdE) T1 lesions, while maintaining a good safety profile. These findings were published online by the journal Multiple Sclerosis.
The results of Phase II showed a 52% reduction of GdE T1 lesions.
One article, reported, "Laquinimod was safe and well-tolerated. The overall frequencies of adverse events were comparable to those observed in the placebo group. No deaths were reported in laquinimod-treated patients. Overall incidence of infections was similar between the two arms of the trial."
Next, some information on Teriflunomide, which is being developed by sanofi-aventis. It works by inhibiting rapidly dividing cells, including activated T cells, which are thought to drive the disease process in MS. Teriflunomide may decrease the risk of infections compared to chemotherapy-like drugs because of its more-limited effects on the immune system.
From a Medscape article:
Results of a phase 3 trial of teriflunomide, an oral disease-modifying therapy, showed a significant reduction in annualized multiple sclerosis (MS) relapse rates with 2 doses of the drug of more than 30% vs placebo.More information can be found in this press release from October 2010.
Disability progression was also significantly reduced by 30% with the higher 14-mg dose, and both doses were well tolerated, with a similar number of patients reporting treatment-emergent adverse events, including serious adverse events, in the treatment and placebo arms.
"Certainly it's safe and effective and is a potential new oral monotherapy for MS with relapses and, again, potentially a first-line treatment given its combination of efficacy and safety characteristics," Paul O'Connor, MD, director of the MS Clinic at St. Michael's Hospital, Toronto, Ontario, Canada, and principal investigator of the TEMSO study told delegates here.
Side effects that were more common in the teriflunomide groups were diarrhea, nausea, alanine transferase increases that were mainly mild and asymptomatic with no dose effect, and mild hair thinning and hair loss, which rarely led to treatment discontinuation.
Hope this is educational! Sounds like there are some exciting new oral therapies coming soon!
For more information about ongoing clinical trials, visit http://www.clinicaltrials.gov/.
Tune in next time for "Future Therapies Continued."