Active Biotech update on laquinimod Development: The U.S, Food and Drug administration rescinds the Special Protocol Assessme...
September 19 2016 - 02:30AM
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(RRMS) was rescinded.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regulatory process, the SPA was rescinded as all changes must be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
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
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
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