Successful Phase III trial of ibalizumab for treatment of resistant HIV-1.- Theratechnologies Inc + TaiMed Biologics, Inc

Theratechnologies Inc. announces that it has been notified by its partner, TaiMed Biologics, Inc, of the preliminary results for the primary end point of the phase III trial with ibalizumab in patients with multi-drug resistant HIV-1 (TMB-301).

Preliminary results indicate that 82.5% of patients enrolled in the phase III study (33/40) have met the primary endpoint of a decrease of at least 0.5 log10 in viral load following a 7-day treatment period with ibalizumab. This result is statistically significantly better than results observed during the control period. The administration of ibalizumab was well tolerated during the first week of treatment. TaiMed plans to submit an abstract to present these results at a major scientific conference later this year. This Phase III study is the last clinical trial required by the FDA to complete the Biologics Licence Application (BLA) submission.

Comment: Ibalizumab is the first humanized monoclonal antibody in clinical trials for the treatment of HIV-1 infection.

Comment: The 24-week treatment study is still underway and should be completed before the end of October 2016. The companies expect to apply for approval next year.