Teriflunomide Significantly Reduced Annualized Relapse Rate and was Well Tolerated in MS Patients
PARIS, August 30, 2010/PRNewswire-FirstCall/ --
- First Results From the TEMSO Phase III Trial to be Presented
During the ECTRIMS Congress in October 2010
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today
that the investigational once-daily oral drug teriflunomide
significantly reduced annualized relapse rate (ARR) at 2 years
versus placebo in patients with relapsing multiple sclerosis (RMS),
thus achieving the primary endpoint in the TEMSO phase III trial.
Both the 7mg and 14mg doses of teriflunomide were well tolerated
with a similar number of patients reporting either
treatment-emergent adverse events (TEAEs) or TEAEs leading to
treatment discontinuation in the treatment arms versus
placebo.
Effects on other clinical and MRI related outcomes further
support the primary outcome. The safety profile was in line with
previous clinical experience.
The TEMSO trial is the first study of a large phase III clinical
development program to produce results on teriflunomide as
monotherapy. Study findings from TEMSO will be presented during the
platform presentation scheduled for October 15, 2010, starting at
9:15 a.m. CET at the 26th Annual Meeting of the European Committee
for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
Gothenburg, Sweden. The TEMSO study results are embargoed until
this oral presentation.
About Teriflunomide
Teriflunomide is a new oral disease modifier for RMS that blocks
de novo pyrimidine synthesis thus reducing T- and B-cells
proliferation with no cytotoxicity. A comprehensive clinical
development program for teriflunomide has been launched in
monotherapy. First Phase II study results of the safety and
efficacy of teriflunomide monotherapy in MS were published in
Neurology in 2006. In addition to the TEMSO trial, two other Phase
III trials, TOWER and TENERE, are ongoing in RMS. A Phase III
study, TOPIC, is also underway in early MS or Clinically Isolated
Syndrome (CIS). Teriflunomide has also been evaluated as an adjunct
therapy to either interferon 1-beta or glatiramer acetate in two
Phase II studies. Results of these studies were presented earlier
this year during the American Committee for Treatment and Research
in Multiple Sclerosis meeting (ACTRIMS) congress, and the American
Academy of Neurology (AAN) meeting respectively. Phase II studies
with teriflunomide (7mg and 14mg) in adjunct with interferon 1-beta
demonstrated an improvement in outcomes, with a consistent safety
profile in patients treated with the adjunct treatment compared
with patients treated with IFN-beta and receiving placebo. In the
other Phase II study, teriflunomide in adjunct to glatiramer
acetate (GA) was well-tolerated compared to patients receiving GA
and placebo. Although there was a numerical trend for the reduction
in number and volume of gadolinium enhancing T-1 brain MRI lesions
in the adjunct arm compared to placebo with GA, the relative effect
was not as robust as that observed for teriflunomide with
IFN-beta.
About TEMSO Study
TEMSO is a 2-year randomized, double-blind, placebo controlled
study including 1088 RMS patients worldwide, aged 18-55 years, with
an Expanded Disability Status Scale (EDSS) <= 5.5 and at least
one relapse over the previous year or at least 2 relapses over the
preceding 2 years. Patients were randomized to placebo or
teriflunomide, 7mg or 14mg, once daily. The primary endpoint was
annualized relapse rate defined as the number of confirmed relapses
per patients-year. The key secondary endpoint was the time to
disability progression measured by EDSS. Safety and tolerability
evaluations were based on treatment emergent adverse events,
physical examinations, vital signs and laboratory
investigations.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, unpredictable and
progressively disabling disease. Patients with MS typically are
diagnosed at a young age and they face a lifetime of uncertainty
with gradually declining health. Today, over two million people
around the world suffer from MS. MS is the result of damage to
myelin, a protective sheath surrounding nerve fibres of the central
nervous system. When myelin is damaged, this interferes with
messages between the brain and other parts of the body. Multiple
sclerosis is a very variable condition and the symptoms depend on
which areas of the central nervous system have been affected. There
is no definite pattern to MS and everyone with MS has a different
set of symptoms, which vary from time to time and can change in
severity and duration, even in the same person. Management of MS is
complex; early intervention in the pathological process is
recommended in order to delay disease progression or at least, slow
it down. A complex support system is required for the care of MS
patients, including health and social services, as well as various
healthcare professionals. Although there is no known cure for
multiple sclerosis, several therapies are proven to be helpful but
there remains an unmet need for new oral therapies with an
acceptable benefit/risk profile.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company,
discovers, develops and distributes therapeutic solutions to
improve the lives of everyone. Sanofi-aventis is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).
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Source: Sanofi-aventis
Media contact: Philippe BARQUET, Tel: +33(0)6-70-48-61-28, Email: philippe.barquet@sanofi-aventis.com
Posted: August 2010
