Laquinimod is an oral, immunomodulatory investigational drug with a novel mechanism of action, preventing neurodegeneration and inflammation in the central nervous system. Laquinimod is in development for once-daily treatment of Huntington’s disease (HD), a rare neurodegenerative disease, and in July 2018 top line data from a phase 2 study in patients with this diseases was announced. Laquinimod has been granted Orphan Drug Designation for this indication by the FDA, which provides for seven years of market exclusivity in the event of future registration. Active Biotech is seeking a strategic partner for a pivotal clinical trial and further commercialization of laquinimod in HD.
Active Biotech entered in 2004 a development and license agreement with Teva Pharmaceutical Industries Ltd for laquinimod. In September 2018, Active Biotech regained the global development and commercialization rights for laquinimod from Teva.
In July, 2018, Active Biotech provided an update that the Phase 2 LEGATO-HD study, evaluating the safety and efficacy of laquinimod as a treatment in Huntington’s disease (HD), did not meet its primary endpoint slowing disease development. However, the secondary endpoint, reduction of brain atrophy, was met. Laquinimod showed a very good safety profile in the study. Furthermore, laquinimod showed an effect on the explorative endpoint Q-Motor, which is a sensitive, objective and standardized method to measure motor function in patients. Analysis of additional exploratory parameters is ongoing and will be presented at upcoming scientific meetings. Results from the study have so far been presented at scientific conferences in September and October 2018:
- Presentation at the annual conference in the Huntington Study Group, HSG 2018, November 2018 – view the complete poster here.
- Presentation at the European Huntingtons Disease Network (EHDN) annual meeting, September 2018 – view the complete poster here.
The previous clinical development program evaluating laquinimod in multiple sclerosis (MS) includes three completed phase 3 studies, ALLEGRO, BRAVO and CONCERTO in relapsing remitting MS (RRMS) and the completed Phase 2 study, ARPEGGIO in primary progressive MS (PPMS). Development of laquinimod in MS has been discontinued.