Active Biotech: New data on laquinimod from the Phase 2 LEGATO-HD study in Huntington’s disease will be presented at the International congress of Parkinson’s disease and movement disorders

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. Hayden<sup>3 

1</sup>University 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 Hayden<sup>2

1</sup>George-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. Hayden<sup>2

1</sup>George-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

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, 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)

For further information, please contact:
Helén Tuvesson, CEO
Tel +46 46 19 21 56, Email: 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 (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.

Active Biotech AB
(org.nr 556223-9227)
Box 724, 220 07 Lund
Tel. +46 46 19 20 00

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.

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• New data on laquinimod from the Phase 2 LEGATO-HD study in Huntington’s disease will be presented at the International congress of Parkinson’s disease and movement disorders