Active Biotech Regains Full Rights to Laquinimod from Teva, Plans to Continue Work on Potential MS Oral Therapy

Active Biotech announced it has regained global development and commercialization rights over laquinimod, its investigational oral therapy for multiple sclerosis (MS), from Teva Pharmaceuticals.

Teva released rights to laquinimod after the company decided not to continue with its clinical development. Teva will give Active Biotech full rights and data generated in the preclinical and clinical development program that Teva has conducted since 2004. The companies, based in Sweden (Active Biotech) and Israel (Teva), had been working together to advance laquinimod.

“We are grateful for the good collaboration with Teva and for the broad development program that has been carried out for laquinimod,” Helén Tuvesson, chief executive officer of Active Biotech, said in a press release.

“The pronounced effect of laquinimod on brain atrophy demonstrated in both RRMS [relapsing-remitting MS] and HD [Huntington’s disease] patients supports our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases, a disease area where the medical need remains high. Therefore, we will assess all opportunities for a continuation of the development of laquinimod,” Tuvesson added.

Laquinimod is an oral active modulator of the immune system that changes the behavior of immune cells of the central nervous system.

The two companies announced the beginning of a more expanded collaboration to advance laquinimod’s program in 2014.

Laquinimod was evaluated as a potential MS therapy in three Phase 3 clinical trials in RRMS patients, and a Phase 2 study in primary progressive MS (PPMS) patients.

While some results showed positive effects of laquinimod on both relapse-related endpoints and MRI (magnetic resonance imaging) parameters, one of the Phase 3 studies, the CONCERTO trial (NCT01707992), reported that it failed to slow disease progression in about 2,200 RRMS patients, the study’s primary intended outcome. Following this failure, Active Biotech and Teva announced that laquinimod would no longer be developed as a potential RRMS therapy, although Active Biotech appears to have reconsidered this.

Laquinimod also failed to slow brain atrophy and PPMS progression in the ARPEGGIO Phase 2 study (NCT02284568), aiming to evaluate laquinimod’s efficacy, safety, and tolerability in about 370 PPMS patients.

A recent study in a mouse model of MS, however, found that laquinimod might treat or prevent optic neuritis — inflammation of the optic nerve — that is often a first symptom of MS.