Active Biotech provides update on laquinimod in Huntington's disease
31 July 2018 - 5:15PM
PRESS RELEASE
Lund Sweden, July 31, 2018 -Active Biotech (NASDAQ OMX
NORDIC: ACTI) today provided an update regarding the clinical
development of laquinimod by Teva Pharmaceutical Industries Ltd.
The Phase 2 LEGATO-HD trial evaluating the safety and efficacy of
laquinimod as a treatment in Huntington's disease (HD) did not meet
its primary endpoint of change from baseline after 12 months of
treatment, as measured by the Unified Huntington's Disease Rating
Scale - Total Motor Score (UHDRS-TMS). The study's secondary
endpoint, reduction of brain atrophy (measured by caudate volume)
was met. The safety results were similar to the expected event
profile in this patient population.
Study data will be fully analyzed. Teva will
submit study results for presentations at future medical meetings
and publication in peer-reviewed journals.
ABOUT LEGATO-HD
LEGATO-HD is a multicenter, multinational, randomized,
double-blind, placebo-controlled, parallel-group Phase 2 study of
laquinimod as a potential treatment in patients with HD. The study
was designed to evaluate three doses arms (0.5mg, 1.0mg, and 1.5mg
daily) versus placebo. Cardiovascular safety concerns were observed
in multiple sclerosis studies with laquinimod doses of 1.2mg and
1.5mg. Although no similar concern was identified in LEGATO-HD,
Teva discontinued the 1.5mg arm in January 2016 as a precautionary
safety measure and continued to evaluate the efficacy and safety of
the 0.5mg and 1.0mg doses.
Overall, 352 patients were randomized. At
baseline, there were similar numbers of males and females with a
mean age of 43.9 years, mean UHDRS-TMS score of 24.4, and mean
UHDRS-Total Functional Capacity (TFC) score of 11.1. 287
patients completed the study and 65 terminated early, including the
30 patients who stopped study when the 1.5 mg dose was
terminated.
The primary endpoint evaluated the change from
baseline at month 12 in the UHDRS-TMS for the 1.0 mg dose as
compared to placebo. The secondary endpoint measured the percent
caudate atrophy (the percent change in caudate volume) from
baseline at month 12 in the 1.0 mg dose as compared to placebo.
Exploratory outcomes included the change in the UHDRS-TMS and the
percent caudate atrophy both for the 0.5 mg dose, and changes in
measures of motor function, cognitive function, functional
capacity, and brain volumes for the 1.0 and 0.5 mg doses
individually. Safety measures included adverse event reporting,
clinical laboratory tests, vital signs, electrocardiograms,
physical examinations, and suicidality.
Teva Pharmaceutical Industries Ltd. has held the
commercialization and development rights for laquinimod since 2004.
The LEGATO-HD study is sponsored by Teva Pharmaceutical Industries
Ltd. in collaboration with the Huntington Study Group and the
European Huntington's Disease Network. This study is registered as
NCT02215616 in clinicaltrials.gov and its EudraCT number is
2014-000418-75.
Lund, July 31, 2018
Active Biotech AB (publ)
Helén Tuvesson
President and CEO
For further information, please
contact:
Hans Kolam, CFO
Tel +46 46 19 20 44
Helén Tuvesson, CEO
Tel +46 46 19 21 56
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 development for neurodegenerative diseases in
partnership with Teva Pharmaceutical Industries Ltd. ANYARA, an
immunotherapy, in development for cancer indications in partnership
with NeoTX Therapeutics Ltd. Furthermore, commercial activities are
conducted for the tasquinimod, paquinimod and SILC projects. Please
visit http://www.activebiotech.com/en for more information.
Active Biotech AB
(Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund, Sweden
Tel: +46 (0)46 19 20 00
This information is information
that Active Biotech is obligated 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 09.15 a.m. CET on July 31, 2018.
Active Biotech provides update on
laquinimod in Huntington's disease
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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