TMC125: iniziano innovativi studi di fase III

La Tibotec comunica l’inizio degli studi di fase III del TMC 125, un nuovo NNRTI. Gli studi (2, su 600 pazienti in 18 paesi, randomizzati, controllati da placebo) sono rivolti a pazienti pre-trattati, con documentata resistenza agli NNRTI e almeno 3 mutazioni primarie agli IP.

In questi studi, l’IP utilizzato sarà il TMC 114. Questi studi pionieristici che associano due farmaci in sperimentazione sono supportati dalle autorità regolatorie americane ed europee e dalla comunità dei pazienti.

L’avvio degli studi segue la presentazione a 24 settimane degli studi di fase II sul TMC 125 a Dublino durante l’EACS:

TMC125-C223 was a phase 2b dose–ranging, randomized, partially-blinded study in HIV-1 infected patients with substantial treatment experience and documented evidence of NNRTI resistance and 3 or more protease mutations. Despite the patients’ NNRTI resistance, the viral load reduction in patients receiving TMC125 was significantly greater than in the active control at the 24-week primary endpoint. The mean change from baseline in viral load was –1.04, –1.18 and –0.19 log10 copies/ml in the TMC125 400 and 800 mg bid and active control groups, respectively.

TMC125-C203 was a Phase II dose-escalation trial in which the primary objective was to assess the safety and tolerability of TMC125. The most common adverse events (AEs) were diarrhoea, headache, rash and nausea with the incidence of AEs not substantially different between TMC125 and placebo.