Proventus

Making Life Fairer

 

Help-Line 01233 334 879

 

Working together to make a difference

Disease Modifying Drugs & Therapies

 

 

Find Us Here

You tube
Follow Provpeter on Twitter
You Tube
twitter

If you have experienced any adverse side effects from a medication or therapy - Report it

Laquinimod - ABR-215062              

A novel once daily, orally administered immunomodulatory compound developed as a disease modifying treatment.

A new type of immumodulatory agent for relapsing remitting multiple sclerosis (RRMS), led to a 40% reduction in lesions, according to results of a multicenter, placebo-controlled phase IIb trial.

Laquinimod affects the levels of certain cytokines (substances released by immune cells) and reduces the passage of immune cells into the brain and spinal cord. Ref

Patients treated with laquinimod at a dose of 0.6 mg a day averaged 2.6 gadolinium-enhancing lesions on MRI compared with 4.2 for the placebo group (P=0.0048) as reported by Giancarlo Comi, M.D., of the University Vita-Salute and colleagues in the June issue of The Lancet.

The between-group difference emerged early in the trial, and follow-up beyond the primary study period demonstrated even larger reductions in MRI-detected lesions with laquinimod versus placebo.

Additionally, the number of new lesions was reduced by 50% in the laquinimod group.

 

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

Teva Pharmaceutical Industries Ltd. and Active Biotech AB 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 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, M.D., 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."

   

Laquinimod is a novel once-daily, orally administered immunomodulatory compound developed as a disease modifying treatment for multiple sclerosis (MS). [1]

A recent Phase II study of oral laquinimod concluded that it is well tolerated and effective in suppressing development of active MRI lesions in relapsing MS. Treatment over six months resulted in a 30% decrease in MRI disease activity. People with disease activity at the start of the study showed a decrease of more than 40%.

A second, 9-month phase II study, using a higher dose has been recently completed, showing a statistically significant effect on decreasing the number of active lesions in the brain, as well as a clear trend of reducing the number of clinical relapses.

Phase III clinical trials are in preparation [2]

 

Teva - The company announced that FDA granted fast track designation to laquinimod Feb. 12. Phase IIb study results showed oral laquinimod administered daily reduced MRI disease activity in RRMS patients and showed a favourable trend toward reducing relapse rate compared to placebo. Teva is eyeing a potential launch in 2011.

 

Source: Teva Pharmaceutical Industries Ltd

 

  1. Polman C et al. Treatment with laquinimod reduces development of active MRI lesions in relapsing MS. Neurology 2005;64(6):987-991.
  2. The Lancet - Comi G, et al "Effect of laquinimod on MRI-monitored disease activity in aptients with relapsing-remitting multiple sclerosis: a multicenter, randomized, double-blind, placebo-controlled phase IIb study" Lancet 2008; 371: 2085-2092. (20/06/08)

Top of Page