Theratechnologies Inc. (Theratechnologies) (TSX: TH) announced today that its partner, TaiMed Biologics, Inc., has completed the submission to the Food and Drug Administration (FDA) in the United States of the Biologics License Application (BLA) of ibalizumab in the treatment of human immunodeficiency virus type 1 drug-resistant (HIV-1 PRM). If approved, ibalizumab will be the first antiretroviral treatment with a new mechanism of action to be launched in nearly 10 years and the only treatment requiring no daily intake. In view of the fact that ibalizumab obtained the status of therapeutic breakthrough and orphan drug, TaiMed requested that “
The ibalizumab BLA is based on data from the TMB-301 Phase III clinical trial, which was a 24-week non-comparative ibalizumab study in addition to optimal baseline therapy (TBO) in Of patients already treated for HIV-1 infection that is multi-drug resistant. The complete results of this study were recently presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI).
“The BLA submission is an important milestone for patients, physicians and all those who have worked tirelessly to make this important drug available to people living with HIV-1 PRM,” said Luc Tanguay, President And CEO, Theratechnologies Inc. “This is a significant step in the development of our product portfolio, which supports our mission to improve the lives of people living with HIV,” added Mr. Tanguay.
As HIV multiplies in the body, it sometimes happens that the virus mutates and produces drug-resistant strains. When this happens, drugs that manage to control a person’s viral load may no longer be effective, leading to treatment failure. Approximately 20,000 to 25,000 Americans are infected with HIV-1 currently resistant to at least one drug in each of the three classes of antiretroviral therapy, and up to 12,000 of these patients will experience virological failure during one Treatment period of 48 weeks, requiring their physician to modify their treatment.
“While some people may be able to contain their viral load with currently approved therapies, there is an urgent need for new options to counter multi-drug resistance,” said Christian Marsolais, Ph.D., senior vice president And Chief Medical Officer, Theratechnologies Inc.
“We are sensitive to the fact that some people living with HIV-1 have special needs and we will continue to offer solutions to help them live healthier lives,” concluded Mr. Tanguay.
Ibalizumab is a humanized monoclonal antibody under study and under development for the treatment of drug-resistant HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds to the secondary extracellular domain of the CD4 + T cell receptor, away from major histocompatibility class II receptors. Potentially, it prevents infection of CD4 + T immune cells by HIV while retaining normal immunological functions. Ibalizumab demonstrates activity against HIV-1 resistant to all other currently approved antiretroviral agents.
Ibalizumab has been designated as a “therapeutic breakthrough” by the US Food and Drug Administration (FDA), which is granted where therapy can potentially provide a substantial improvement over what is already available for treatment A serious and life-threatening condition. The FDA also granted it the designation of “orphan drug”.
About the Phase III study of ibalizumab, TMB-301
The TMB-301 clinical trial was a 24-week, non-comparative study of ibalizumab in addition to an optimized baseline treatment (TBO) in 40 patients already treated for HIV-1 drug-resistant drug. The main objective of the study was to demonstrate the antiviral activity of ibalizumab seven days after receiving an initial dose of ibalizumab. Patients who received their failing antiretroviral therapy (ART) or no therapy were followed for a seven-day control period. Subsequently, a single initial dose of 2000 mg of intravenous (IV) ibalizumab was the only treatment added to their ART. The primary efficacy endpoint was the proportion of patients achieving = 0.5 log10 reduction, HIV-1 ribonucleic acid (HIV-1 RNA) seven days after initiation of treatment with ibalizumab, ie on the fourteenth day of the study. Ibalizumab was subsequently administered at 800 mg IV every two weeks for the duration of the 24-week study. A total of 40 patients were enrolled for the study. At the end of the treatment period, patients had the opportunity to participate in the expanded-access study (TMB-311). TMB-311 is also available for US patients with limited treatment options.
Source: Theratechnologies Inc.