TMC278 Pivotal Phase 3 Clinical Trials Achieve Primary Objective
- Data on investigational, once-daily TMC278, the third antiretroviral compound developed by Tibotec Pharmaceuticals, presented at International AIDS Conference -
VIENNA, July 22 /PRNewswire/ -- Tibotec Pharmaceuticals
announced today results from two pivotal Phase 3, double-blind,
randomized clinical trials comparing the efficacy, safety and
tolerability of its investigational non-nucleoside reverse
transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus
efavirenz (EFV), each administered once daily with a
nucleoside/nucleotide background regimen in treatment-naive,
HIV-1-infected adults. These global trials, known as ECHO and
THRIVE, reached their primary objective, which was to demonstrate
non-inferiority of TMC278 vs. EFV in the proportion of patients
achieving an undetectable viral load (less than 50 copies/mL) at
week 48 (with a maximum allowable difference of 12 percent). A
pooled analysis of ECHO and THRIVE was presented today at the XVIII
International AIDS Conference in Vienna, Austria.
ECHO and THRIVE pooled results showed that 84.3 percent of
patients (n=686) in the TMC278 group reached an undetectable viral
load, compared with 82.3 percent of patients (n=682) in the EFV
group. The difference between the treatment groups was not
significant. Patients received TMC278 (25 mg) or EFV (600 mg), each
administered once daily in combination with a nucleoside/nucleotide
background regimen. The virologic failure rate was 9 percent in the
TMC278 group and 4.8 percent in the EFV group.
TMC278 is an investigational product, and the safety and
efficacy has not yet been established. Tibotec plans to submit
these results to the U.S. Food and Drug Administration (FDA) to
support approval of TMC278 for use in treatment-naive adult
patients.
"I'm very excited by the findings of these Phase 3 results for
TMC278," said Calvin J. Cohen, M.D., M.Sc., lead clinical
investigator and Research Director at Community Research Initiative
of New England and Harvard Vanguard Medical Associates. "These
studies provide valuable information on the safety and tolerability
of TMC278 and, specifically, its metabolic and CNS side effect
profiles."
Adverse events (AEs) leading to discontinuation in the TMC278
group were 3.4 percent compared to 7.6 percent in the EFV group,
and Grade 2-4 AEs at least possibly related to treatment were 15.9
percent in the TMC278 group versus 31.1 percent in the EFV group.
Grade 2-4 AEs of interest by organ class reported among patients in
the TMC278 group versus the EFV group were psychiatric (14.9
percent vs. 22.7 percent), neurological (17.1 percent vs. 37.8
percent) and rash-all types (3.1 percent vs. 13.6 percent). Grade
3/4 lipid abnormalities were also reported among patients in the
TMC278 group versus the EFV group for increases in total
cholesterol (0.1 percent vs. 2.5 percent), LDL-cholesterol (0.7
percent vs. 4.1 percent) and triglycerides (0.3 percent vs. 2.2
percent).
About ECHO and THRIVE
ECHO (TMC278-TiDP6-C209) and THRIVE (TMC278-TiDP6-C215) are
pivotal Phase 3, double-blind, randomized studies that evaluated
the efficacy, safety and tolerability of TMC278 in 1,368
treatment-naive, HIV-1-infected adults. ECHO (Efficacy Comparison
in treatment-naive HIV-infected subjects Of TMC278 and EFV)
evaluated TMC278 (25 mg) once daily, versus EFV (600 mg) once
daily, combined with a fixed background regimen consisting of
emtricitabine + tenofovir disoproxil fumarate. THRIVE (TMC278
against HIV, in a once daily RegImen Versus Efavirenz) evaluated
TMC278 (25 mg) once daily versus EFV (600 mg) once daily, combined
with an investigator-selected background regimen consisting of two
N[t]RTIs (abacavir + lamivudine or emtricitabine + tenofovir
disoproxil fumarate or zidovudine + lamivudine).
Each study is being conducted at more than 100 sites, in more
than 20 countries. The studies will last for a total of 104 weeks,
which includes a four-week screening period, a 96-week treatment
period and a four-week follow-up period.
Tibotec Pharmaceuticals plans to file the 48-week findings from
ECHO and THRIVE with the FDA when seeking marketing authorization
for TMC278. Pending approval, Tibotec Therapeutics will
commercialize TMC278 in the United States. Tibotec has also entered
into a license and collaboration agreement with Gilead Sciences,
Inc. (NASDAQ:GILD) for the development and
commercialization of a once-daily, fixed-dose combination of TMC278
and Gilead's Truvada® (emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg).
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, based in Cork, Ireland, is a
pharmaceutical research and development company. The Company's main
research and development facilities are in Beerse, Belgium, with
offices in Titusville, NJ, USA. Tibotec is dedicated to the
discovery and development of innovative HIV/AIDS drugs and
anti-infectives for diseases of high unmet medical need.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Centocor Ortho Biotech
Products, L.P., headquartered in Titusville, NJ, is dedicated to
delivering innovative virology therapeutics that help healthcare
professionals address serious unmet needs in people living with
HIV.
Tibotec Pharmaceuticals and Centocor Ortho Biotech Products,
L.P. are subsidiaries of Johnson & Johnson.
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995.
These statements are based on current expectations of future
events. If underlying assumptions prove inaccurate or unknown risks
or uncertainties materialize, actual results could vary materially
from Tibotec Pharmaceuticals and/or Johnson & Johnson's
expectations and projections. Risks and uncertainties include
general industry conditions and competition; economic conditions,
such as interest rate and currency exchange rate fluctuations;
technological advances and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approvals; domestic and foreign health care reforms and
governmental laws and regulations; and trends toward health care
cost containment. A further list and description of these risks,
uncertainties and other factors can be found in Exhibit 99 of
Johnson & Johnson's Annual Report on Form 10-K for the fiscal
year ended January 3, 2010. Copies of this Form 10-K, as well as
subsequent filings, are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. Neither
Tibotec Pharmaceuticals nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new
information or future events or developments.
Truvada is a registered trademark of Gilead Sciences, Inc.
Contact: Hans Vanavermaete
Mobile: +32 (0) 478 44 72 78
Pamela Van Houten
Mobile: +1 908-295-7367
Source: Tibotec Pharmaceuticals
CONTACT: Hans Vanavermaete, Mobile: +32 (0) 478 44 72 78, or
Pamela Van
Houten, Mobile: +1-908-295-7367
Posted: July 2010
