ARPEGGIO and LEGATO-HD trials will further evaluate the effect of
laquinimod in neurodegenerative diseases
JERUSALEM & LUND, Sweden--(BUSINESS WIRE)--Nov. 4, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Active Biotech
(NASDAQ OMX NORDIC:ACTI) today announced the expansion of the laquinimod
clinical development program with the initiation of the ARPEGGIO trial,
which will evaluate the potential of laquinimod to treat primary
progressive multiple sclerosis (PPMS). Additionally, Teva has screened
the first patient in the LEGATO-HD trial, which will evaluate laquinimod
in Huntington’s disease. Currently, there are no approved therapies
available for the treatment of PPMS or the treatment of Huntington’s
disease, beyond symptom management.
“Teva prides itself in striving to help patients with neurodegenerative
diseases through research and innovation,” said Michael Hayden, M.D.,
Ph.D., President of Global R&D and Chief Scientific Officer at Teva
Pharmaceutical Industries, Ltd. “Laquinimod has been shown to modulate
several significant pathways common to key neurodegenerative disease.
More specifically, it modulates the immune cell lineages in the
periphery and in the CNS. We look forward to the results from both of
these studies.”
The ARPEGGIO study will evaluate the efficacy, safety and tolerability
of laquinimod in patients with PPMS with a primary endpoint of percent
brain volume change (PBVC) through MRI analysis. PPMS is characterized
by the worsening of neurologic function without distinct relapses (also
called attacks or exacerbations). Approximately 15 percent of MS
patients fall into the PPMS category.
The LEGATO-HD study will evaluate the efficacy, safety and tolerability
of once-daily oral laquinimod as a potential treatment for adult
patients with Huntington’s disease. The primary endpoint for LEGATO-HD
is change from baseline in the Unified Huntington’s Disease Rating
Scale-Total Motor Scale (UHDRS-TMS) as defined by the sum of the scores
of all UHDRS-TMS sub-items after 12 months of treatment. Huntington’s
disease is caused by a genetically-programmed degeneration of brain
cells in select areas of the brain, which results in uncontrolled
movements, loss of intellectual faculties and personality and emotional
disturbances. Huntington’s disease affects about five to seven people
per 100,000 in Western countries.
For further details on the Phase II ARPEGGIO and LEGATO-HD studies,
please search laquinimod at ClinicalTrials.gov.
About ARPEGGIO
The study, A Randomized
Placebo-controlled Trial Evaluating
Laquinimod in PPMS, Gauging Gradations
In MRI and Clinical Outcomes
(ARPEGGIO) is a multinational, multicenter, randomized, double-blind,
parallel-group, placebo-controlled, Phase II clinical trial.
ARPEGGIO is intended to serve as a proof-of-concept study for potential
treatment with laquinimod in PPMS. The trial will evaluate two doses of
laquinimod (0.6 and 1.5mg/day) in PPMS compared to placebo. The primary
endpoint of the study is brain atrophy as defined by PBVC from baseline
to week 48. Secondary endpoints include time to confirmed disability
progression, the number of new T2 lesions and change in the Brief
International Cognitive Assessment for Multiple Sclerosis (BICAMS)
score. ARPEGGIO has an estimated completion date of H2 2017.
About LEGATO-HD
LEGATO-HD (Laquinimod Efficacy
and Safety in a GlobAl Trial
Of HD)
is a multicenter, randomized, double-blind, placebo-controlled,
parallel-group study to evaluate the efficacy and safety of laquinimod
treatment at doses of 0.5, 1.0, and 1.5 mg/day in 400 adult Huntington’s
disease patients between the ages of 21-55. Ancillary studies will
evaluate microglia activation, neuronal integrity, and peripheral
inflammatory biomarkers. LEGATO-HD has an estimated completion date of
H1 2017.
The primary endpoint of LEGATO-HD is change from baseline in the Unified
Huntington’s Disease Rating Scale-Total Motor Scale (UHDRS-TMS) as
defined by the sum of the scores of all UHDRS-TMS sub-items after 12
months of treatment. Secondary endpoints will measure brain atrophy,
cognition, clinical global impression and functional capacity.
About Laquinimod
Laquinimod is a once-daily oral, investigational, CNS-active
immunomodulator with a novel mechanism of action being developed for the
treatment of relapsing-remitting MS (RRMS), progressive MS and
Huntington’s disease. The global, Phase III, clinical development
program evaluating laquinimod in MS includes two completed pivotal
studies, ALLEGRO and BRAVO (both 0.6mg/day). A third Phase III trial,
CONCERTO, is currently ongoing and evaluating two doses of laquinimod
(0.6mg and 1.2mg/day) in approximately 2,100 patients for up to 24
months. The primary outcome measure is time to three-month
confirmed-disability progression as measured by the Expanded Disability
Status Scale (EDSS).
In the ALLEGRO and BRAVO trials, adverse reactions observed included
headache, abdominal pain, back and neck pain, appendicitis, and mild,
asymptomatic laboratory abnormalities, including liver enzyme
elevations, hematological changes and elevation of CRP or fibrinogen
levels.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules, sold in more than 100 countries, and with a direct
presence in about 60 countries. Teva's specialty medicine businesses
focus on CNS, including pain, respiratory, oncology, and women's health
therapeutic areas as well as biologics. Teva currently employs
approximately 45,000 people around the world and reached $20.3 billion
in net revenues in 2013.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC:ACTI) is a biotechnology company
with focus on autoimmune/inflammatory diseases and cancer. In pivotal
phase is laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis.
Also tasquinimod for the treatment of prostate cancer, with a unique
mode of action, is in pivotal phase. In addition, laquinimod has
concluded Phase II development for Crohn's and Lupus. The company has
two additional projects in clinical development, ANYARA primarily for
the treatment of renal cell cancer and the orally administered compound
paquinimod (57-57) for systemic sclerosis. Please visit www.activebiotech.com
for more information.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix,
215-591-8912
United States
or
Ran Meir,
215-591-3033
United States
or
Tomer Amitai, 972
(3) 926-7656
Israel
or
PR:
Iris Beck Codner,
972 (3) 926-7687
Israel
or
Denise Bradley,
215-591-8974
United States
or
Nancy Leone,
215-284-0213
United States
or
Active Biotech AB
Tomas
Leanderson, +46-46-19-20-95
or
Hans Kolam,
+46-46-19-20-44