Laquinimod Phase IIb Trial Confirms Efficacy and Favorable Safety Profile and Shows Significant Reduction in the Rate of Inflammatory Disease Activity
Tuesday September 5, 10:35 am ET
The once-daily novel oral agent for relapsing remitting multiple sclerosis (MS) patients, met its primary end-point.
JERUSALEM & LUND, Sweden--(BUSINESS WIRE)--Sept. 5, 2006--Teva Pharmaceutical Industries Ltd (Nasdaq: TEVA - News) and Active Biotech AB (ACTI.ST) today announced that a Phase IIb study designed to evaluate the safety and efficacy of laquinimod, a once-daily novel oral agent, in relapsing remitting multiple sclerosis (MS) patients, met its primary end-point.
Laquinimod treatment significantly reduced the rate of inflammatory disease activity, as measured by the cumulative number of Gadolinium enhancing lesions on brain MRI scans after 36 weeks of treatment. Laquinimod treatment also demonstrated a considerable reduction in the number of clinical relapses compared to placebo. This Phase IIb multi-center, randomized, double-blind, placebo-controlled study enrolled approximately 300 patients in 8 European countries and in Israel.
The evaluation of the safety and side-effect data confirmed the favourable safety profile that was seen in earlier phase II clinical trials. The majority of the patients who participated in the study are currently continuing treatment with laquinimod in an ongoing, blinded extension study.
"The study results with once daily oral laquinimod are very encouraging and further demonstrate our ongoing commitment to developing new classes of therapies for MS, including oral therapies, to treat the disease, as well as to improve the patients' quality of life", said Israel Makov, President and CEO of Teva Pharmaceutical Industries Ltd..
"As of today, nearly 400 patients have received laquinimod in various clinical trials over the last years. The data from the completed studies together with preclinical documentation, confirm laquinimod's efficacy and favorable safety profile in MS patients," said Sven Andreasson, President and CEO of Active Biotech AB.
The positive result of the clinical trial triggers a milestone payment to Active Biotech.
Further details about the study will be given at Teva's Innovative R&D Day in New York City on September 26th, 2006. A complete presentation of the Phase IIb data will be given at upcoming relevant scientific meetings.
Teva is discussing laquinimod's development plan with regulatory authorities in order to accelerate the clinical program into Phase III.
About Laquinimod
Laquinimod is a novel once-daily, orally administered immunomodulatory compound developed as a disease modifying treatment for multiple sclerosis (MS). Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries Ltd. in June 2004. |
