MONTREAL, Nov. 10, 2016 /PRNewswire/ -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) today announced that it has been notified by its partner, TaiMed Biologics, Inc., of the preliminary results for the safety and efficacy secondary endpoints of the 24-week Phase III trial with ibalizumab in patients with multi-drug resistant (MDR) HIV-1 (TMB-301). This Phase III trial confirms the safety and efficacy results of ibalizumab observed in the previously completed Phase IIb study, despite the fact that the patient population in the Phase III trial had higher levels of MDR HIV-1 and more advanced disease at time of enrollment. In the Phase III trial, after 24 weeks of treatment, the mean reduction in viral load was 1.6 log 10 and a total of 48% of patients had a reduction in viral load of more than 2.0 log 10 during this period. At the end of the treatment period using ibalizumab with optimized background regimen (OBR), the proportion of study participants with undetectable viral load (HIV-1 <50 copies/mL) was 43% (mean viral load reduction of 3.1 log 10) and 53% of patients had a viral load lower than 400 copies/mL. The mean viral load of patients at baseline was 100,287 copies/mL. As previously announced, the preliminary results also indicated that 83% of patients enrolled in the Phase III trial (33/40, p<0.0001) have met the primary endpoint of a decrease of = 0.5 log 10 in viral load following a 7-day treatment period with ibalizumab. The safety results in this Phase III trial are consistent with the ones previously observed in the Phase IIb study. Other than for one case of immune reconstitution inflammatory syndrome, an inflammatory response in HIV-infected patients that may be triggered after changing to more active antiretroviral therapy (ART), no serious adverse events (SAEs) were considered to be related to ibalizumab. Most treatment-emergent adverse events reported were mild to moderate in severity. No notable trends in laboratory abnormalities were observed.