Primary endpoint reached in phase II clinical trial of Active Biotech's substance for oral treatment of multiple sclerosis

17-Sep-2003

A first analysis of the main parameters in Active Biotech's clinical Phase II study with laquinimod (SAIK-MS) for oral treatment of multiple sclerosis (MS) has shown that the study's primary endpoint was reached. The primary endpoint was to show, with the aid of magnetic resonance imaging (MRI), a statistically significant reduction in the disease activity in patients treated with laquinimod during a six-month period.

An evaluation of the safety and side-effects data shows that the product has a highly advantageous safety profile.

The results indicate that patients treated with 0.3 mg/day of laquinimod showed a statistically significant reduction in MRI activity of 30% compared with patients who received a non-active substance (placebo). Patients who were treated with 0.1 mg/day of laquinimod also showed a decline in disease activity. However, it was not statistically significant from the placebo group.

Regarding the secondary objectives related to clinical outcome, this preliminary analysis only includes a limited view on the number of exacerbations and on the EDSS clinical score. This analysis indicated that only approximately 25 % of all patients had an exacerbation during the treatment period and that the mean EDSS score remained stable. As expected, due to the short treatment period, a statistically significant difference between the different treatment groups could not be detected.

An in-depth analysis of all parameters is under way and a complete report will be presented on 6 November at IVA (Royal Academy of Engineering Sciences) in Stockholm, in conjunction with a capital market day on the same date. An invitation will be forwarded separately.

https://www.bionity.com/en/news/28649/primary-endpoint-reached-in-phase-ii-clinical-trial-of-active-biotech-s-substance-for-oral-treatment-of-multiple-sclerosis.html