Active Biotech

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

Sweden'sĀ Active BiotechĀ said its experimental therapyĀ LaquinimodĀ failed to meet the primary and secondary objectives of Phase 2 clinical trial evaluating the drug's potentialĀ to treat primary progressive multiple sclerosis. Laquinimod, also known asĀ NerventraĀ orĀ ABR-215062, was developed by Active Biotech and Israel'sĀ 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 ā€” 0.6 and 1.5 mg/day ā€” 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,Ā Active Biotech said the lower dose of laquinimod failed to slow both the rate of brain atrophy and disease progression.Ā ā€œThere was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6 mg,ā€ said the company's president and CEO, HelĆ©n 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 BiotecĀ 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 Huntingtonā€™s disease in a Phase 2 clinical trial.

MS Drug Under Study No Longer Being Given in Higher Doses to Patients

Teva Pharmaceutical Industries Ltd. and Active Biotech have discontinued the use of higher doses of the drug laquinimod in two ongoing multiple sclerosis (MS) studies. The decision was based on a recommendation byĀ the Data Monitoring Committee (DMC)Ā that isĀ supervising the clinical trials afterĀ cardiovascular events, none of which were fatal,…

Teva and Active Biotech Expand Investigational MS Treatment Program

Drug manufacturersĀ Teva Pharmaceutical Industries Ltd.Ā and Active Biotech announced that they expanding the ongoing clinical research program for the study ofĀ laquinimod, a potential treatment for primary progressive multiple sclerosis (PPMS), as the companies are now initiating theĀ ARPEGGIO trial. In addition, Teva has also announced…