PRESS RELEASE
New data from the Phase 2 LEGATO-HD study of laquinimod in Huntington's disease will be presented at the scientific conference HSG 2018
Lund Sweden, November 8, 2018 - Active Biotech (NASDAQ STOCKHOLM: ACTI) announces that new data from the Phase 2 LEGATO-HD study of laquinimod in Huntington's disease will be presented by Global Coordinating Principal Investigator, Dr Ralf Reilmann at the annual Huntington Study Group conference, HSG 2018, in Houston, Texas November 8-10. The results will be presented at an oral session on November 9 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". In addition to previously presented data on primary and secondary endpoints and safety profile, results for exploratory endpoints will be presented. Data for Q-Motor, a sensitive, standardized rate-independent and unbiased measure, revealed nominal improvement on motor coordination in patients treated with laquinimod. These data together with the strong treatment effect on brain volume loss propose a central effect of laquinimod in the LEGATO-HD study. Additional 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.
ABOUT LEGATO-HD
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.
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 (Q-motor), 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 November 8, 2018
Active Biotech AB (publ)
For further information, please contact:
Helén Tuvesson, CEO
Tel +46 46 19 21 56Email: helen.tuvesson@activebiotech.com
Hans Kolam, CFO
Tel +46 46 19 20 44
Email: hans.kolam@activebiotech.com
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
(org.nr 556223-9227)
Box 724, 220 07 Lund
Tfn +46 46 19 20 00
The information was submitted for publication at 13.00 p.m. CET on November 8, 2018.
