Phase IIa Laquinimod Trial Results Show Positive Data for Potential Use in Active Crohn's Disease
Teva Pharmaceutical Industries Ltd.IR:United States215-591-8912orUnited States267-468-4281orIsrael972 (3) 926-7656orPRIsrael972 (3) 926-7687orUnited States215-591-8974orActive Biotech AB+46-46-19-20-95or+46-46-19-20-44
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the presentation of Phase IIa clinical data for investigational laquinimod in moderate to severe Crohn’s disease (CD). The findings demonstrated that treatment with orally administered laquinimod 0.5 mg/day resulted in a robust, early and consistent effect on remission (48.3% vs. 15.9% of patients, respectively) and response rates (62.1% vs. 34.9% of patients, respectively) in patients with moderate-to-severe CD versus placebo. The data were reported in an oral presentation at the 20 United European Gastroenterology (UEG) Week conference
The full abstract can be found at:
“Our developmental program for laquinimod has demonstrated that the immunomodulatory effects of this oral compound stand to apply to multiple autoimmune diseases, and data presented at UEG showed an impressive impact on clinical remission in Crohn’s disease as early as one week of treatment,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries, Ltd. “These data provide a solid rationale for potential future study of laquinimod in Crohn’s disease.”
The Phase IIa study evaluated the safety and efficacy of various doses of laquinimod (0.5, 1, 1.5, or 2 mg/day) compared to placebo in active CD over eight weeks of treatment with four weeks of follow up. No effect was noted on remission/response at higher doses. Additionally, laquinimod 0.5 mg and 1 mg doses were generally well-tolerated, with adverse events similar to those seen with placebo. The data are currently undergoing further analysis and evaluation to finalize next steps in the CD clinical development plan.
The Phase IIa, multicenter, randomized, double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of laquinimod in 180 patients with moderate to severe active CD, based on a CD Activity Index (CDAI) of 220-450 and serum C-reactive protein (CRP) levels of >5mg/L or mucosal ulcerations evident on a recent endoscopy. The study tracked four dose cohorts who received laquinimod 0.5 mg/day, 1 mg/day, 1.5 mg/day, 2 mg/day, or placebo for eight weeks with four weeks follow-up. Approximately 45 patients were enrolled in each cohort in a 2:1 ration between laquinimod and placebo. Stable concomitant therapies and prior anti-tumor necrosis factor (TNF) use among patients was permitted in the study.
Laquinimod is a novel oral immunomodulator under clinical development for the treatment of multiple sclerosis (MS), Crohn’s disease (CD) and systemic lupus erythematosus (SLE or lupus). Human and animal models suggest laquinimod exerts its therapeutic effect by modulating the immune system cells, mainly resulting in a down regulation of pro-inflammatory cytokines.
CD is a chronic inflammatory condition that affects the gastrointestinal tract. The symptoms of CD can vary significantly among afflicted individuals. The main gastrointestinal symptoms are abdominal pain, diarrhea, or weight loss. CD can also cause complications outside of the gastrointestinal tract such as skin rashes, arthritis, and inflammation of the eye.
The precise cause of CD is not known. CD is considered to be an autoimmune disease. This autoimmune activity produces inflammation in the gastrointestinal tract. CD is classified as an inflammatory bowel disease, IBD.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011.
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in or entering pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, TASQ for prostate cancer as well as ANYARA for use in cancer targeted therapy, primarily of renal cell cancer. In addition, laquinimod is in Phase II development for Crohn's and Lupus. Further projects in clinical development comprise the two orally administered compounds, 57-57 for SLE & Systemic Sclerosis and RhuDex(TM) for RA. Please visit for more information.