Active Biotech: Data from the Phase 2 LEGATO-HD study of laquinimod in Huntington's disease will be presented at "European Huntington's Disease Network (EHDN) plenary meeting 2018"September 13, 2018 11:00 (CEST)
Data from the Phase 2 LEGATO-HD study of laquinimod in Huntington's disease will be presented at the scientific conference "European Huntington's Disease Network (EHDN) plenary meeting 2018"
Lund Sweden, September 13, 2018 - Active Biotech (NASDAQ STOCKHOLM: ACTI) announces that initial data from the Phase 2 LEGATO-HD study of laquinimod in Huntington's disease will be presented by Global Coordinating Principal Investigator, Dr Ralf Railmann at the scientific conference "European Huntington's Disease Network (EHDN) plenary meeting 2018" held September 14-16 in Vienna. The results will be presented at an oral session on September 16 and as a poster titled "LEGATO-HD Study: A phase 2 study assessing the efficacy and safety of laquinimod as a treatment for Huntington disease". Data presented includes results on primary and secondary endpoints and safety profile. Full analysis of the study is ongoing and further results will be presented at upcoming scientific meetings.
The poster will be available on Active Biotech's website (www.activebiotech.com) in connection with the presentation.
LEGATO-HD is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 study of laquinimod as a potential treatment in patients with HD. The study was designed to evaluate three doses arms (0.5mg, 1.0mg, and 1.5mg daily) versus placebo. The highest dose of 1.5 mg was discontinued in January 2016 as a precautionary measure after cardiovascular safety problems were observed in multiple sclerosis studies with laquinimod of 1.2 mg and 1.5 mg respectively. No similar issues were identified in the LEGATO-HD study.
The primary endpoint evaluating the change from baseline at month 12 in the UHDRS-TMS for the 1.0 mg dose as compared with placebo was not achieved. The secondary endpoint, percent change in brain atrophy (caudate volume) from baseline at 12 months in the 1.0 mg dose as compared to placebo, was met. The safety profile in the study was similar to that expected in the patient population.
Full analysis of the study is ongoing and the exploratory outcome includes change of Unified Huntington's Disease Rating Scale - Total Motor Score (UHDRS-TMS) and percentage change in brain atrophy for the 0.5 mg dose, as well as changes in measured motor function, cognitive function, functional capacity and brain volumes for the 1.0 and 0.5 mg doses individually. The safety measures included adverse event reporting, clinical laboratory tests, vital signs, electrocardiograms, physical examinations and suicidality.
The study was conducted by Teva in collaboration with the Huntington Study Group and European Huntington's Disease Network. The study is registered as NCT02215616 on clinicaltrials.gov and its EudraCT number is 2014-000418-75.
Lund September 13, 2018
Active Biotech AB (publ)
For further information, please contact:
Hans Kolam, CFO
Tel +46 46 19 20 44
Helén Tuvesson, CEO
Tel +46 46 19 21 56
Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties in development for neurodegenerative diseases. ANYARA, an immunotherapy, in development for cancer indications in partnership with NeoTX Therapeutics Ltd. Furthermore, commercial activities are conducted for the tasquinimod, paquinimod and SILC projects. Please visit http://www.activebiotech.com/en for more information.
Active Biotech AB
Box 724, 220 07 Lund
Tfn +46 46 19 20 00
The information was submitted for publication at 11.00 a.m. CET on September 13, 2018.