Teva Pharmaceutical Industries Ltd. and Active Biotech AB has announced the initiation of enrolment in the Allegro trial (assessment of oral laquinimod in preventing progression of multiple sclerosis).
Allegro is a global pivotal, 24/30-month, double-blind, phase III study designed to evaluate the efficacy, safety and tolerability of the oral investigational compound laquinimod versus placebo in the treatment of relapsing-remitting multiple sclerosis (RRMS). The Allegro trial aims to enrol approximately 1,000 patients with RRMS.
"Currently, there are several RRMS treatments available; however, they are all administered via injection or infusion. An orally administered therapy brings us one step closer to offering patients and physicians a highly effective, new, convenient and less invasive method of drug delivery," said Doug Jeffery, MD, Ph.D., Associate Professor, Wake Forest University Baptist Medical Centre. "Previous phase II studies have demonstrated positive results for laquinimod, and we hope that results from this pivotal phase III trial will further reinforce these findings".
Recently, Teva concluded a 36-week extension of the 36-week phase IIb core trial, which demonstrated that laquinimod 0.6 mg met its primary endpoint. The data from this extension trial further confirmed and strengthened the results from the initial 36-week phase IIb trial. The majority of the patients that have participated in the trial are now receiving treatment with laquinimod in a continued open-label extension trial.
"The initiation of phase III clinical trial is a critical milestone for Teva in our commitment to the MS community," said Moshe Manor, group vice president - global innovative resources, of Teva Pharmaceutical Industries Ltd. "We are excited about the development of Laquinimod, which together with Copaxone, will broaden our MS platform and position Teva as a leading company in the MS field".
Additional new data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on October 13, 2007 in Prague, demonstrated that laquinimod reduced inflammation, demyelination and axonal damage in an animal model experimental autoimmune encephalomyelitis (EAE), indicating that the compound may have both anti-inflammatory and neuroprotective properties.
Based on encouraging results from various animal models, laquinimod is now being investigated for other autoimmune diseases. "We are very pleased to see how Teva has successfully advanced the laquinimod clinical trial program in order to bring a novel, first-in-class product to the market for the treatment of MS," said Sven Andr?son, president and CEO of Active Biotech AB.
The efficacy, safety, and tolerability of laquinimod will also be studied in an additional phase III pivotal trial in RRMS (BRAVO), which is expected to begin enrolment in the first quarter of 2008. This trial is a multinational, multi-centre, randomized, parallel-group, placebo-controlled study which will compare the effects of laquinimod to those of placebo, and provide risk-benefit data comparing once-daily orally administered laquinimod to a product presently used for treatment of RRMS (an active comparator). This study plans to enrol approximately 1,200 participants who will be followed for 24 months.