Theratechnologies Announces New Data from the Pivotal Phase III Trial of HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab - Seite 3

A total of 9 patients (23%) discontinued the Phase III trial prior to the completion of the 24 week trial treatment (4 non-drug related deaths, 3 withdrawals, and 2 lost to follow-up). The statistical analysis method used for efficacy, intent-to-treat - missing equals failure (ITT-MEF), represents the most stringent and most conservative data handling convention. The ITT-MEF analysis methodology considers all patients enrolled in the trial and any missing values are treated as failure (or no change) in the analysis of the results.

About TMB-301, ibalizumab Phase III study

TMB-301 was a single arm, 24-week study of ibalizumab plus optimized background regimen (OBR) in treatment-experienced patients infected with multidrug resistant HIV-1. The primary objective of the study was to demonstrate the antiviral activity of ibalizumab seven days after the first dose of ibalizumab. Patients receiving their current failing antiretroviral therapy (ART), or no therapy, were monitored during a seven-day control period. Thereafter, a single loading dose of 2,000 mg of intravenous (IV) ibalizumab was the only ART added to their regimen. The primary efficacy endpoint was the proportion of patients achieving a ≥ 0.5 log₁₀ decrease in HIV-1 RNA seven days after initiating ibalizumab therapy, day 14 of the study. Ibalizumab was continued at doses of 800 mg IV every two weeks through 24 weeks on study treatment. A total of 40 patients have been enrolled in the study. After completion of treatment, patients were offered participation in the expanded access study (TMB-311). Study TMB-311 is also open for US patients with limited options. For more information about TMB-301 (NCT 02475629) and TMB-311 (NCT02707861), please refer to the ClinicalTrials.gov website (www.clinicaltrials.gov).

About Ibalizumab

Ibalizumab is an investigational humanized monoclonal antibody currently being developed for the potential treatment of MDR HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents. Ibalizumab has been tested in Phase I and II clinical trials and the Phase III trial is the last pivotal clinical study necessary for the completion of a BLA expected to be filed with the FDA.