laquinimod and BG00012

A board to discuss future MS therapies in early stage (Phase I or II) trials.

laquinimod and BG00012

Postby dignan » Wed Nov 07, 2007 9:23 am

A couple of oral drugs with already announced phase 3 trials have commenced enrollment. Of the oral drugs that have started enrolling phase 3 trials, the order of expected finish, from first to last, is: mylinax, teriflunomide, FTY720, BG00012, laquinimod.



Initiation of Enrollment in Pivotal Phase III Clinical Study of Oral Laquinimod for Relapsing-Remitting Multiple Sclerosis

Teva and Active Biotech announced today the initiation of enrollment 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 enroll 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, M.D., Ph.D., Associate Professor, Wake Forest University Baptist Medical Center. "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 Andréasson, 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 enrollment in the first quarter of 2008. This trial is a multinational, multi-center, 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 enroll approximately 1,200 participants who will be followed for 24 months.

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Participants Sought for Two New Clinical Trials of Oral Drug BG00012 for Relapsing-Remitting MS

November 2, 2007 - Summary: Enrollment has begun for two large-scale clinical trials testing the safety and effectiveness of the experimental oral drug BG00012 (dimethyl fumarate, Biogen Idec, Inc) in people with relapsing-remitting multiple sclerosis. These phase III studies are known as the DEFINE study and the CONFIRM study. The DEFINE study compares two different doses of BG00012 against inactive placebo, and is enrolling 1011 patients at 160 sites in North America, Europe and other parts of the world. The CONFIRM study compares two different doses of BG00012, or injections of glatiramer acetate (Copaxone, Teva Pharmaceutical Industries), against inactive placebo. That study is enrolling 1232 patients at 175 sites in North America, Europe and other parts of the world. Both studies are being sponsored by Biogen Idec, Inc.

People with relapsing-remitting MS experience clearly defined flare-ups (also called relapses, attacks, or exacerbations) of acute worsening of neurologic function, followed by partial or complete recovery periods (remissions) free of disease progression.

Rationale: Multiple sclerosis occurs when the immune system mistakenly attacks nerve fiber-insulating myelin and other brain and spinal cord tissues. Although its exact mechanism of action is not known, BG00012, an oral fumarate, is thought to inhibit immune cells and molecules and may be protective against damage to the central nervous system. Preliminary results of an earlier multicenter, controlled clinical trial of oral BG00012 involving 257 people with relapsing-remitting MS were reported at a major medical meeting in 2006. For 24 weeks, patients received either low, medium or high doses of BG00012 capsules or inactive placebo. Compared with placebo, treatment with high dose BG00012 led to a 69% reduction in active inflammation on MRI scans acquired at weeks 12 to 24.

Eligibility: To enroll in either of these phase III studies, people must be 18-55 years of age, and must have a confirmed diagnosis of relapsing-remitting MS. Other entrance and exclusion criteria apply.

Details of DEFINE: The primary goal of the DEFINE study is to determine whether BG00012 can decrease the proportion of participants experiencing relapses and whether the agent is safe and well tolerated. Secondary objectives include assessing the drug’s effects on the frequency of relapses, disability progression, disease activity detected by MRI and other measures.

For the two-year DEFINE study, participants will be randomly assigned to one of 3 groups:

Group 1 will take 2 capsules orally, 3 times a day, of low dose BG00012 plus placebo (240 mg 2 times a day plus 2 inactive placebo capsules once a day);

Group 2 will take 2 capsules orally, 3 times a day of high dose BG00012 (240 mg 3 times a day);

Group 3 will take 2 capsules orally, 3 times a day of placebo.

Contact: For information on sites that are currently enrolling for the DEFINE study, please contact DEFINE@dandersoncompany.com.

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dignan
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