Multiple Sclerosis Clinical Trial Update: Laquinimod

What is laquinimod?

Laquinimod is a once-daily oral medication that has been developed and tested for the treatment of relapsing-remitting multiple sclerosis (RRMS) and primary progressive MS (PPMS).

The mechanism of action for laquinimod is not well understood.  Previous studies have suggested that it may work through a combination of protecting nerves and exerting an anti-inflammatory activity.  In particular, the use of laquiniqmod in animal models of MS has shown that it can decrease nerve damage, prevent immune cells from entering the central nervous system and create a less inflammatory environment.

What have previous studies shown?

The results of two phase III trials have been published into the use of laquinimod in people with multiple sclerosis.  The findings are summarised below:

ALLEGRO:  a 2 year randomised, blinded trial comparing the effects of laquinimod versus placebo.  In this study, laquinimod significantly reduced relapse rate, confirmed disability progression and the total number of lesions.  It was also seen that a higher proportion of people in the treatment group were relapse free during the trial period.

BRAVO:   a 2 year randomised, blinded trial comparing the effects of laquinimod and interferon-beta 1a versus placebo.  The results of this trial were less straightforward, as a difference in the groups at baseline had to be adjusted for.  After accounting for those differences, it was found that laquinimod significantly reduced relapse rate, confirmed disability progression and the percentage of brain volume loss.

What are the latest findings?

The results of the CONCERTO trial have just been announced by Teva.  This large trial aimed to investigate the potential for laquinimod to decrease confirmed disability progression in approximately 1800 people with RRMS.  Unfortunately, the findings showed that laquinimod did not meet the primary endpoint – that is – it did not significantly decrease the disease progression in people with RRMS compared to placebo.

Some of the secondary endpoints, such as change in brain volume and relapse rate, were achieved.  Dr Michael Hayden (Chief Scientific Officer from Teva) has suggested that although they “are disappointed by not meeting the primary endpoint…positive results on a number of secondary and exploratory endpoints…fuels our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases”

What is the future?

Teva have confirmed that they will not be pursuing laquinimod as a treatment option for RRMS.  However, they will continue their trials in PPMS and Huntington’s Disease.  We will await the release of the PPMS results and provide updates when they are available.

The press release of the CONCERTO findings can be viewed here.