Laquinimod Fails to Slow Brain Atrophy and PPMS Progression, Says Developer Active Biotech

Sweden's Active Biotech said its experimental therapy Laquinimod failed to meet the primary and secondary objectives of Phase 2 clinical trial evaluating the drug's potential to treat primary progressive multiple sclerosis. Laquinimod, also known as Nerventra or ABR-215062, was developed by Active Biotech and Israel's Teva Pharmaceutical Industries. The drug targets inflammation and degeneration in neurological tissue. Preclinical studies using animal models of multiple sclerosis showed that laquinimod regulated inflammatory and immune responses in these animals, reducing disease progression. The ARPEGGIO Phase 2 study aimed to evaluate laquinimod's efficacy, safety and tolerability in PPMS patients. Its primary endpoint was brain atrophy as defined by percent brain volume change. Secondary goals included time to disability progression, change in timed 25-foot walk, and number of new T2 lesions. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 374 individuals. Initially, the study aimed to evaluate two doses of laquinimod — 0.6 and 1.5 mg/day — in PPMS compared to placebo. However, the highest dose was discontinued in January 2016 after some participants reported adverse cardiovascular events. In a Dec. 1 press release, Active Biotech said the lower dose of laquinimod failed to slow both the rate of brain atrophy and disease progression. “There was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6 mg,” said the company's president and CEO, Helén Tuvesson. The trial revealed a similar safety profile to that observed in previous studies in relapsing-remitting MS patients (RRMS). The most common adverse reactions were headache, nasopharyngities, upper respiratory tract infection,and back pain. Results of the ARPEGGIO trial will likely be presented at a future scientific conference and published in a scientific journal. Earlier this year, Active Biotec stopped developing laquinimod as a potential RRMS treatment after a Phase 3 study failed to achieve its primary goal: slowing disease progression. Laquinimod is also being evaluated as a potential therapy for Huntington’s disease in a Phase 2 clinical trial.

Teva Pharmaceuticals to Present New Data on Multiple Sclerosis Drugs Copaxone and Laquinimod at ECTRIMS 2015

The world’s largest generic medicines manufacturer, Teva Pharmaceutical, is at the 31st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress currently ongoing in Barcelona, from October 7-10, 2015. Teva will be presenting the latest findings on its relapsing multiple sclerosis (MS) therapy COPAXONE® (glatiramer acetate injection), and product candidate for…

Teva, Active Biotech Present Positive Findings for RRMS Experimental Therapy Laquinimod

During the 30th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) last week in Boston, Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), together with Active Biotech (NASDAQ OMX NORDIC:ACTI), presented new follow-up data evaluating the clinical safety of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS)…

Multiple Sclerosis Drug Nerventra® (Laquinimod) Disapproved in EU; Drug Developers Will Continue Research

Two pharmaceutical companies, Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech, have just confirmed reports that the Committee for Medicinal Products for Human Use (CHMP) is not recommending NERVENTRA (laquinimod) for use in treating relapsing-remitting multiple sclerosis (RRMS) within the European Union (EU), according to a recent press release. Despite CHMP’s disapproval of TEVA…