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Active Biotech: Nya data från fas 2-studien LEGATO-HD med laquinimod i Huntingtons sjukdom presenteras på den internationella kongressen ”Parkinson’s disease and movement disorders”

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Lund den 23 september, 2019 - Active Biotech (NASDAQ STOCKHOLM: ACTI) meddelar att nya data från fas 2-studien LEGATO-HD med laquinimod i Huntingtons sjukdom kommer att presenteras i Nice, Frankrike, på den internationella kongressen Parkinson’s disease and Movement disorders 22-26 september, 2019. Resultaten kommer att presenteras i tre postrar.

Abstrakt och postrar kommer att finnas tillgängliga på Active Biotech hemsida (www.activebiotech.com) i anslutning till presentationen.


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

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


OM LEGATO-HD
LEGATO-HD är en multinationell, multicenter, randomiserad, dubbelblind, placebokontrollerad, parallellgrupp, fas 2-studie av laquinimod som potentiell behandling av patienter med Huntingtons sjukdom. Studien utformades för att utvärdera tre doser (0,5 mg, 1,0 mg och 1,5 mg dagligen) jämfört med placebo. Den högsta dosen, 1.5 mg avbröts i januari 2016, som en försiktighetsåtgärd efter att kardiovaskulära säkerhetsproblem observerats i multipel skleros-studier med laquinimod på 1,2 mg respektive 1,5 mg. Inga liknande problem identifierades i LEGATO-HD studien.

Det primära studiemålet, att utvärdera förändring efter 12 månaders behandling jämfört med studiestart i UHDRS-TMS, för dosen 1,0 mg jämfört med placebo uppnåddes inte. Däremot uppnåddes det sekundära målet procentuell förändring av hjärnatrofi (caudatusvolym) efter 12 månader jämfört med studiestart för dosen 1,0 mg jämfört med placebo. Säkerhetsprofilen i studien var likvärdig med den förväntade i patientpopulationen.

I de explorativa utfallen ingår förändring av Unified Huntington's Disease Rating Scale - Total Motor Score (UHDRS-TMS) och procentuell förändring i hjärnatrofi för dosen 0,5 mg, samt förändringar i uppmätt motorisk funktion (Q-motor), kognitiv funktion, funktionskapacitet, neuronal integritet och astrocytos (MRS) såväl som hjärnvolymer för doserna 1,0 respektive 0,5 mg var för sig. Säkerhetsmåtten omfattade rapporterade biverkningar, kliniska laboratorietester, vitalparametrar, EKGs, fysiska undersökningar och självmordsbenägenhet. 
Studien genomfördes av Teva i samarbete med Huntington Study Group och European Huntington's Disease Network. Studien är registrerad som NCT02215616 på clinicaltrials.gov och dess EudraCT-nummer är 2014-000418-75.

Lund den 23 september, 2019
Active Biotech AB (publ)

För ytterligare information, vänligen kontakta:

Helén Tuvesson, VD
Tel +46 46 19 20 95

Hans Kolam, CFO
Tel +46 46 19 20 44


Active Biotech AB (publ)
(NASDAQ Stockholm: ACTI) är ett bioteknikföretag fokuserat på utveckling av läkemedel för behandling av neurodegenerativa/inflammatoriska sjukdomar och cancer. Laquinimod, en substans i tablettform med unika immunmodulerande egenskaper utvecklas för neurodegenerativa sjukdomar. ANYARA (naptumumab), en immunterapi, befinner sig i utveckling för behandling av cancer i samarbete med NeoTX Therapeutics Ltd. Vidare bedrivs kommersiella aktiviteter för projekten tasquinimod, paquinimod och SILC. För ytterligare information besök www.activebiotech.com.

Active Biotech AB
(org.nr 556223-9227)
Box 724, 220 07 Lund
Tfn 046 19 20 00

Denna information är sådan information som Active Biotech AB är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersons försorg,  för offentliggörande den 23 september, 2019, kl. 08.30.

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