NASDAQ OMX

Active Biotech: Information om den kliniska studien LEGATO-HD

11.1.2016 08:30 | NASDAQ OMX

Dela

Lund, January 11, 2016 - Active Biotech (Nasdaq Stockholm: ACTI) today announces that its partner Teva Pharmaceutical Industries Ltd, will amend the trial design in a Phase 2 study of laquinimod in Huntington's disease. The amendment consists of dropping the highest of three doses (1.5 mg/day) in the trial while keeping two remaining active doses (0.5 and 1 mg/day) unchanged. This is a precautionary measure in the interest of patient safety being suggested by Teva to the Data Safety Monitory Board (DSMB) for the LEGATO-HD trial.

DSMB godtog rekommendationen efter att ha gått igenom de data som observerat kardiovaskulära biverkningar hos patienter som fått höga doser laquinimod i två olika kliniska studier för multipel skleros (MS) och som rapporterades den 4 januari 2016. Inga kardiovaskulära biverkningar har observerats på någon av dosnivåerna i studien LEGATO-HD. Teva är fortsatt starkt engagerad i att studera laquinimod för behandling av Huntingtons sjukdom.

För närvarande är de underliggande orsakerna till de kardiovaskulära biverkningarna i MS-studierna okända. Även om ingen specifik relation vad gäller exponeringstid för denna biverkan kunnat identifieras, kan kardiovaskulära riskfaktorer och demografi vara av vikt.

För ytterligare information, vänligen kontakta:
Tomas Leanderson, VD
Tfn 046 19 20 95

Hans Kolam, CFO
Tfn 046 19 20 44

Active Biotech AB
Box 724, 220 07 Lund
Tfn 046-19 20 00
Fax 046-19 11 00

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, är i registreringsgrundande fas 3-prövning för behandling av relapserande remitterande multipel skleros. Laquinimod är även i fas 2-prövningar för behandling av primärprogressiv multipel skleros och Huntingtons sjukdom. Vidare bedrivs kommersiella aktiviteter för projekten ISI, ANYARA och paquinimod. För ytterligare information besök www.activebiotech.com.

Active Biotech är skyldigt att offentliggöra informationen i detta pressmeddelande enligt lagen om värdepappers-marknaden och/eller lagen om handel med finansiella instrument. Informationen lämnades för offentliggörande den 11 januari 2016, kl. 08.30.




This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Active Biotech via Globenewswire

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