Lund, Sweden-31 July 2018 — Active Biotech (NASDAQ OMX NORDIC: ACTI) announces an update on the clinical development of laquinimod, which is carried out by Teva Pharmaceutical Industries Ltd (Teva). Phase 2-the study LEGATO-HD, which evaluates the safety and efficacy of laquinimod as a treatment of Huntington’s disease (HD) did not meet its primary objective, the change after 12 months of treatment compared with study start, as measured by the Unified Huntington’s Disease Rating Scale — Total Motor Score (UHDRS-TMS). Positive study results for the secondary objective, the reduction of hjärnatrofi (measured as the volume of the caudate) was achieved. The safety profile was equivalent to that expected in the patient population.
A full analysis of the study data will be implemented. Teva will present the study results at upcoming medical congresses and published in peer-reviewed scientific journals.
LEGATO-HD is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallellgrupp, phase 2 study of laquinimod as a potential treatment of patients with Huntington’s disease. The study was designed to evaluate three doses (0.5 mg, 1.0 mg and 1.5 mg daily) against placebo. The cardiovascular vulnerability was observed in multiple sclerosis-studies with two doses of laquinimod 1.2 mg and 1.5 mg. Although no similar problems were identified in the LEGATO-HD discontinued the Teva group that received 1.5 mg in January, 2016 on the grounds of prudence and continued to evaluate the efficacy and safety with the dosages of 0.5 mg and 1.0 mg.
All in all randomized 352 patients. At the start was the number of women and men equally, with an average age of 43.9 years, with an average score of 24.4, according to the UHDRS-TMS-the scale and an average total capability to function 11.1 according to the scale UHDRS-Total Functional Capacity (TFC). 287 patients completed the study and 65 ended prematurely, of which 30 patients completed the study when högdosen 1.5 mg was interrupted.
The primary objective was to evaluate the change after 12 months of treatment compared with study start in the UHDRS-TMS, for the dose of 1.0 mg compared with placebo. The secondary objective was the percentage change of the hjärnatrofi (caudatusvolym) after 12 months compared with the start of the dose to 1.0 mg compared with placebo. In the exploratory outcomes included change in UHDRS-TMS and the percentage change in the hjärnatrofi for the dose of 0.5 mg, as well as changes in the measured motor function, cognitive function, capability to function and hjärnvolymer for the doses of 1.0 and 0.5 mg. Safety indicators included the reported adverse reactions, clinical laboratory tests, vitalparametrar, EKGs, physical examinations and suicidal tendencies.
Teva holds since 2004 the rights to the commercialization and development of laquinimod. The study LEGATO-HD is carried out 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, 31 July 2018
Active Biotech AB (publ)
Helén And Held
For further information, please contact:
Hans Kolam, CFO
Tel 046 19 20 44
Helén and Held, PRESIDENT
Tel 046 19 21 56
Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company focused on the development of drugs for the treatment of neurodegenerative/inflammatory diseases and cancer. Laquinimod, a substance in tablet form with unique immunomodulatory properties is in development for neurodegenerative diseases in collaboration with Teva Pharmaceutical Industries Ltd. ANYARA, a form of immunotherapy, is in development for the treatment of cancer in cooperation with the NeoTX Therapeutics Ltd. Furthermore, the conducted commercial activities for the projects tasquinimod, paquinimod and SILC. For further information please visit www.activebiotech.com.
Active Biotech AB
Box 724, 220 07 Lund, Sweden
Tel 046-19 20 00
This information is such information that Active Biotech is obligated to publish under the EU marknadsmissbruksförordning. The information was submitted, by the above contact person in the government, for publication on 31 July 2018, there is a 09.15 CET.
Active Biotech provides update on laquinimod in HD
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Source: Active Biotech via Globenewswire