Lund Sweden, September 23, 2019 - Active Biotech (NASDAQ STOCKHOLM: ACTI) announces that new data from exploratory analysis of the Phase 2 LEGATO-HD study of laquinimod in Huntington’s disease will be presented at the International congress of Parkinson’s disease and Movement disorders in Nice, France, September 22-26, 2019. The data will be presented in three posters.
The abstracts and posters will be available on Active Biotech's website (www.activebiotech.com) in connection with the presentation.
P24 - Magnetic Resonance Spectroscopy Evaluation of Neuronal Integrity and Astrocytosis in a Phase 2 study of Laquinimod as a Treatment for Huntington Disease (LEGATO-HD)
Blair R. Leavitt1, Ralf Reilmann2, Mark Forrest Gordon3, Karen E. Anderson4, Andrew Feigin5, Sarah J. Tabrizi6, Julie C. Stout7, Paola Piccini8, Bretta Russell-Schulz1, Alex L. Mackay1, Beth Borowsky3, Gail Rynkowski3, Rita Volkinshtein3, Juha-Matti Savola3, Michael R. Hayden3
1University of British Columbia, 2George-Huntington-Institute, 3Teva Pharmaceuticals, 4MedStar Georgetown University Hospital & Georgetown University Medical Center, 5NYU Langone Health, 6UCL Institute of Neurology, 7Monash University, 8Imperial College Hayden3
P43 - Brain MRI Volume Changes after 12 months laquinimod treatment of Huntington disease (LEGATO-HD)
Ralf Reilmann1, Mark Forrest Gordon2, Karen E. Anderson3, Andrew Feigin4, Sarah J. Tabrizi5, Blair R. Leavitt6, Julie C. Stout7, Paola Piccini8, Nicola Hobbs9, Richard Manber9, Beth Borowsky2, Gail Rynkowski2, Rita Volkinshtein2, Juha-Matti Savola2 and Michael Hayden2
1George-Huntington-Institute, 2Teva Pharmaceuticals, 3MedStar Georgetown University Hospital & Georgetown University Medical Center, 4NYU Langone Health, 5UCL Institute of Neurology, 6University of British Columbia, 7Monash University, 8Imperial College, 9IXICO plc, London
P44 - Quantitative Motor (Q-Motor) Assessments Suggest a Beneficial Central Effect of Laquinimod in a Phase II Study in Huntington Disease (LEGATO-HD)
Ralf Reilmann1, Mark Forrest Gordon2, Robin Schubert1, Karen E. Anderson3, Andrew Feigin4, Sarah J. Tabrizi5, Blair R. Leavitt6, Julie C. Stout7, Paola Piccini8, Beth Borowsky2, Gail Rynkowski2, Rita Volkinshtein2, Juha-Matti Savola2, Michael R. Hayden2
1George-Huntington-Institute, 2Teva Pharmaceuticals, 3MedStar Georgetown University Hospital & Georgetown University Medical Center, 4NYU Langone Health, 5University College of London, 6University of British Columbia, 7Monash University, 8Imperial College London
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, neuronal integrity and astrocytosis (MRS) as well as 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.
Active Biotech AB (publ)
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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 (naptumumab), 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 www.activebiotech.com for more information.
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This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 08.30 a.m. CET on September 23, 2019.