Active Biotech update on laquinimod Development: The U.S, Food and Drug administration rescinds the Special Protocol Assessment for laquinimod
(Thomson Reuters ONE) -
Lund, September 19, 2016 - Active Biotech (Nasdaq Stockholm: ACTI) provided an
update today on laquinimod which is being developed in multiple sclerosis (MS)
and Huntington's disease (HD) by Teva Pharmaceutical Industries, Ltd. The U.S.
Food and Drug Administration (FDA) has informed Teva that the Special Protocol
Assessment (SPA) for the Phase III CONCERTO clinical trial evaluating laquinimod
in relapsing remitting multiple sclerosis (RRMS) was rescinded.
Both companies confirmed in January 2016 that the highest dose arms in two MS
trials and one trial in HD were discontinued at the recommendation of the Data
Monitoring Committees (DMC). In February, 2016, Teva submitted to the FDA an
amendment to the SPA to account for this change. However, per FDA regulatory
process, the SPA was rescinded as all changes must be agreed to prior to
implementation of the change. This requirement could not be fulfilled in the
current case, since the DMC recommendation triggered an immediate action to
withdraw the 1.2 mg dose for the treatment of RRMS in the interest of patient
safety.
The CONCERTO trial continues with one dose (0.6mg/day) vs. placebo on the
original schedule, and Teva plans to use this pivotal trial to support filing
for marketing approval for laquinimod in the US and EU, as previously
communicated. No change is anticipated in the trial's completion date.
Teva has completed two Phase III trials with the 0.6mg daily dose in RRMS and
continues long-term extension studies of laquinimod at this dose. Laquinimod is
currently being studied in RRMS, primary progressive MS (PPMS) and Huntington
disease (HD).
For further information, please contact:
Tomas Leanderson, President and CEO Active Biotech AB
Tel: +46 46 19 20 95 (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Hans Kolam, CFO Tel: +46 46 19 20 00
Tel: +46 46 19 20 44 Fax: +46 46 19 11 05
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, is
in pivotal Phase 3 development for the treatment of relapsing remitting multiple
sclerosis. Also, laquinimod is in Phase 2 development for the treatment of
primary progressive multiple sclerosis and Huntington's disease. Furthermore,
commercial activities are conducted for the tasquinimod, SILC, ANYARA and
paquinimod projects. Please visit www.activebiotech.com for more information.
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 19 2016.
Active Biotech update on laquinimod Development 19 September 2016:
http://hugin.info/1002/R/2042910/762592.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Unternehmensinformation / Kurzprofil:
Datum: 19.09.2016 - 08:30 Uhr
Sprache: Deutsch
News-ID 495435
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contact information:
Town:
LUND
Kategorie:
Business News
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