Additional results of phase III trial of ibalizumab in HIV/AIDS presented- Theratechnologies

Theratechnologies announced that additional secondary efficacy and safety endpoint results from the 24-week ibalizumab Phase III trial, TMB-301, in HIV/AIDS. Preliminary secondary efficacy and safety endpoint results were announced on November 10, 2016. The new data showed that patients with multidrug resistant (MDR) HIV-1 infection experienced a mean increase in CD4+ T cell of 48 cells/�L after 24 weeks of treatment with ibalizumab plus an optimized background regimen (OBR). These data supplement previously reported findings, where 83% of patients achieved a ? 0.5 log10 decrease in viral load from baseline seven days after the single loading dose of 2000 mg of ibalizumab (primary endpoint) and a mean reduction in viral load of 1.6 log10 over the 24 week treatment period with more than 48% of patients experiencing a viral load reduction of more than 2.0 log10.

Patients enrolled in this Phase III trial experienced a significant decrease in viral load after receiving a single loading dose of ibalizumab 2,000 mg intravenously (IV) in addition to their failing ART (or no therapy). Viral load decreases were maintained during the 24-week trial. At the end of the treatment period, the proportion of study participants with undetectable viral load (HIV-1 <50 copies ml was 43 mean viral load reduction of 3.1 log10 and 50 of patients had a viral load lower than 200 copies ml.>

The safety results in this Phase III trial are consistent with the ones previously observed in the Phase IIb trial. Results were presented at a late-breaker session at the Conference on Retroviruses and Opportunistic Infections (CROI) 2017.