New Data on Investigational Agent TMC278 in Anitretroviral-Naive HIV PatientsPhase 2b Dose-Finding Study
LOS ANGELES, March 01, 2007 /PRNewswire/ -- Tibotec Pharmaceuticals Ltd. presented the first results of the phase 2b dose-finding study of TMC278 at the 14th Conference on Retroviruses and Opportunistic Infections in Los Angeles earlier this week. TMC278 is a next-generation investigational non- nucleoside reverse transcriptase inhibitor (NNRTI). It is currently being studied in treatment-naive HIV patients in phase 2. The safety and efficacy of TMC278 in combination with other antiretroviral agents has not been established.
48-week primary analysis
TMC278-C204 is a randomized, partially blinded, controlled Phase 2b dose- finding study in 368 treatment-naive, adult HIV-1 patients. In this trial, 3 once daily doses of TMC278 -- 25mg (N=93), 75mg (N=95) and 150mg (N=91) -- and efavirenz (EFV) 600mg (N=89) are studied in combination with investigator- selected Combivir (R) or Truvada(R). 33% of the study population is women. The results presented are from the 48-week primary endpoint analysis of the study, which is ongoing to 96 weeks. At 48 weeks, 81% (25mg), 80% (75mg) and 77% (150mg) of patients receiving TMC278, in combination with other antiretroviral agents, had reached the primary endpoint of a confirmed plasma viral load <50 copies/mL; 81% of patients in the efavirenz arm also reached the primary endpoint.
The most common adverse events (AEs), at least possibly related to TMC278 or efavirenz, were dizziness, somnolence, vertigo and nausea, which were 5%, 3%, 1% and 20% across all TMC278 dose groups compared with 27%, 10%, 10% and 18% in the efavirenz group. For TMC278 and EFV respectively, the incidence of serious AEs was 10% vs. 9%, grade 3 or 4 AEs was 25% vs. 16%, and grade 3 or 4 lab abnormalities was 22% vs. 20%.
Rash and nervous system disorders were less frequent in the TMC278 groups, 8% and 33% respectively compared with 19% and 53% in the efavirenz group. Changes in lipids were more pronounced with efavirenz.
"The results from the Phase 2b study suggest that TMC278 may provide an important alternative in the treatment of ARV-naive patients. This will be further investigated in the phase 3 studies," said Dr Anton Pozniak, Chelsea and Westminster Hospital, London.
Based on the study findings, the 75mg dose has been selected for phase 3 development in treatment-naive patients.
Tibotec Investigational NNRTI portfolio
TMC125, Tibotec's first NNRTI, is in phase 3 development for treatment- experienced HIV patients, both trials DUET 1 and DUET 2 are fully recruited. An expanded access program (EAP) for TMC125 is open in the US, Canada and a number of European countries. TMC125 is available to HIV-1 infected adults, at least 18 years old, who have limited treatment options either due to virological failure or intolerance to multiple ARV regimens. Patients must be three-class experienced, having received licensed treatment from each of the 3 major oral classes of anti-HIV drugs (NRTIs, NNRTIs, and PIs), and must have received at least two PI-based regimens.
For more about the program, visit www.clinicaltrials.gov. Healthcare professionals and people living with HIV/AIDS in the US may obtain information by calling 1-866-889-2074 or emailing . TMC125EAP@i3research.com
An earlier development candidate TMC120 (dapivirine) is now being developed as a vaginal microbicide by the International Partnership for Microbicides.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
CONTACT: Karen Manson, cell: +32-479-89-47-99
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Posted: March 2007