Indications -- Psoriasis/Chronic Inflammation Message Board

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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation

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To: Icebrg who wrote (463)	11/6/2003 3:35:06 AM
From: Icebrg	Read Replies (1) of 631

Active Biotech reports some "new" data on their MS-drug laquinimod in the quarterly report. Primary endpoint confirmed in SAIK-MS Phase II study The final analysis confirms that the primary endpoint of Phase II clinical study for the candidate drug SAIK-MS (laquinimod), intended for oral treatment of multiple sclerosis (MS), has been reached. Using magnetic resonance imaging (MRI), the primary endpoint of the study was to demonstrate a statistically significant decrease in disease activity in patients treated with laquinimod over a 24-week period. Patients treated with a laquinimod dose of 0.3 mg/day showed a statistically significant reduction in MRI-activity, compared with patients who received a non-active substance (placebo). A reduction was also shown in patients receiving the lower dose, 0.1 mg/day, but the decrease was not statistically significant after 24 weeks. A more extended evaluation of the study has been made using several different statistical methods to analyse the data. This analysis further strengthen the previously published results of approximately 30% decrease in disease activity. Regardless of analytical method, a statistically significant effect was achieved throughout the entire treatment period for the group that received a laquinimod dose of 0.3 mg/day. Depending on the analytical method used, laquinimod induced a decrease of 28 to 44 % in the number of new inflammatory lesions in the brain (p-value 0.0007 - 0.0498). Patients monitored during the study generally showed a low level of disease activity. A more pronounced effect was observed in patients with higher disease activity. Patients with at least one active lesion in the brain at study start (73 percent of the patients), experienced a 52-percent decline in the number of new MS-related inflammatory lesions. The highly advantageous safety profile initially reported was confirmed in the final analysis. Statistical significance was not achieved in evaluations of laquinimod.s clinical effects. This was not to be expected given the short duration of the study. Thus, in summary, Phase II data support continued development of laquinimod aiming at becoming the first oral product for treatment of MS.

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