Teva Announces Successful Results of Phase III Study with Oral Laquinimod for Multiple Sclerosis

Teva Pharmaceutical Industries Ltd. and Active Biotech announced initial results from the two-year Phase III ALLEGRO study, demonstrating that relapsing-remitting multiple sclerosis (MS) patients treated with 0.6 mg daily oral laquinimod experienced a statistically significant reduction in annualized relapse rate compared to placebo. The study also showed a significant reduction in disability progression, as measured by Expanded Disability Severity Scale (EDSS).

Key Takeaways:

• The Phase III ALLEGRO study met its primary endpoint, demonstrating a statistically significant reduction in annualized relapse rate in relapsing-remitting MS patients treated with 0.6 mg daily oral laquinimod.
• Laquinimod significantly slowed the progression of disability in MS patients, as measured by Expanded Disability Severity Scale (EDSS).
• The overall frequencies of adverse events were comparable to those observed in the placebo group, and no deaths were reported in laquinimod-treated patients.
• The incidence of infections was similar between the two arms of the trial.
• Laquinimod has shown a favorable safety and tolerability profile, making it a promising therapeutic option for the MS community.
• Principal Investigator, Professor Giancarlo Comi, Director of the Department of Neurology and Institute of Experimental Neurology at the University Vite Salute, San Raffaele, Italy, commented: "Laquinimod demonstrated a significant reduction in the progression of disability which may be explained by its unique mechanism of action that includes neuroprotective properties."
• Teva's President and Chief Executive Officer, Shlomo Yanai, stated: "We are very pleased to have achieved this major milestone in the development of oral laquinimod, a novel therapy that can potentially improve the lives of many MS patients in a safe way."

Sources:

• Active Biotech
• Teva Pharmaceutical Industries Ltd.