Theratechnologies Ibalizumab Well Tolerated Via Both Intramuscular and Intravenous Administration

Theratechnologies Inc. announced the results of�pharmacokinetics (PK) and pharmacodynamics (PD) data comparing the intramuscular (IM) with the intravenous (IV) administration of ibalizumab�that was presented at the annual Conference on Retroviruses and Opportunistic Infections�(CROI) 2017.
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The PK and PD of two doses of ibalizumab, 800 mg bi-weekly and 2000 mg every four weeks, administered IM were evaluated under study TMB-121. This data was compared to the PK and PD data of similar doses of ibalizumab administered IV from a previous study. The results showed that the PK and PD profiles of both doses of ibalizumab administered IM were comparable with IV profiles. Ibalizumab was well tolerated when administered IM or IV.
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TMB-121 is a Phase I/II, randomized study primarily assessing the PK/PD of IM administration of�ibalizumab. The study is conducted in Taiwan, by our partner TaiMed Biologics inc, and enrolled patients with HIV-1 RNA > 5000 copies/mL who have not received antiretroviral (ARV) treatment for at least one year.�The primary objective of the study is to evaluate the PK and PD profile of ibalizumab when administered by different routes of administration.
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Ibalizumab is an investigational humanized monoclonal antibody currently being developed for the potential treatment of Multiple Drug Resistant Human Immunodeficiency Virus-1 (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 Biologics License Application (BLA) expected to be submitted to the Food and Drug Administration (FDA).

Ibalizumab has received "Breakthrough Therapy" designation from the FDA. This designation is given to a therapy that may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. Ibalizumab also received "Orphan Drug" designation by the FDA.
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Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients.
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For more information, visit www.theratech.com