Active Biotech update on laquinimod Development: The U.S, Food and Drug administration rescinds the Special Protocol Assessme...
19 September 2016 - 4:44PM
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remitting multiple sclerosis (RRMS) was rescinded.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the SPA was rescinded as all changes must be agreed to prior to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
Tel: +46 46 19 20 95 Hans Kolam, CFO Tel: +46
46 19 20 44 |
Active Biotech AB (Corp.
Reg. No. 556223-9227) Box 724, SE-220 07 Lund Tel: +46 46 19 20 00
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
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