Clinical Trials

Date: 2014-02-19

Type of information: Halting of the trial

phase: 3

Announcement: halting of the trial

Company: Teva Pharmaceutical Industries (Israel) Active Biotech (Sweden)

Product: Nerventra® (laquinimod)

Action mechanism:

immunomodulating agent. This oral, once-daily, immunomodulator with a novel mechanism of action has been developed by Active Biotech. The positive ALLEGRO results are supported by new pre-clinical data, also presented at the AAN meeting, that further establish the mechanism of action of laquinimod, which led to a reduction in axonal damage, the main determinant of permanent clinical disability in MS. Data from the cuprizone model, designed to investigate the effect on neurodegeneration, independent of inflammation, demonstrated that laquinimod reduced demyelination and axonal damage while preserving more myelin-producing cells. This unique effect suggests a direct decrease in nerve damage in the central nervous system (CNS). Additionally, laquinimod was shown to modulate the brain-derived neurotrophic factor (BDNF) pathway, a key factor in maintaining axonal integrity.

Disease: relapsing remitting multiple sclerosis (RRMS)

Therapeutic area: Autoimmune diseases - Neurodegenerative diseases

Country:

Trial details:

LIBRETTO has been designed to evaluate the efficacy, safety and tolerability of two doses of oral laquinimod (0.6 and 1.2 mg/day), compared to interferon beta-1a, in patients with relapsing remitting multiple sclerosis. Primary endpoint of the study will be brain atrophy.
The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III laquinimod trial, CONCERTO, is evaluating two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months. The primary outcome measure will be time to confirmed disability progression as measured by the EDSS.

Latest news:

• On February 19, 2014, Active Biotech has announced that its partner Teva Pharmaceuticals, has decided not to proceed to the randomization stage of the planned Libretto trial for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS), as the current design is no longer aligned with the regulatory strategy. This decision has no impact on other ongoing studies, such as CONCERTO, which are proceeding as planned, or on Teva Pharmaceuticals' plans to initiate clinical studies in Primary Progressive Multiple Sclerosis (PPMS).
• On November 4, 2013, Active Biotech has announced that its partner Teva Pharmaceutical Industries Ltd. will initiate a further clinical trial, LIBRETTO, to evaluate the efficacy, safety and tolerability of two doses of oral laquinimod (0.6 and 1.2 mg/day), compared to interferon beta-1a, in patients with relapsing remitting multiple sclerosis. Primary endpoint of the study will be brain atrophy.