New 48-Week Data Presented at IDWeek Show Trogarzo® Remains Safe and Effective
MONTREAL, Oct. 03, 2019 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that new 48-week data from the TMB-311 extension study confirm that Trogarzo® provides durable viral suppression and a safety profile consistent with the 24-week pivotal Phase III study. Study results were presented today at IDWeek™ in Washington, D.C.
Results come from the expanded access protocol of TMB-311. A total of 38 patients were enrolled in Cohort 2. Patients had a viral load >1,000 copies/mL, resistance to at least 1 antiretroviral from three different classes and full viral sensitivity to at least 1 antiretroviral.
In Cohort 2 patients, viral load reduction at week 24 and week 48 was comparable. Respectively, 46 percent and 47 percent of patients taking Trogarzo® and an optimized background regimen consisting of at least one fully active agent reached a viral load reduction below 50 copies/mL. Furthermore, at both timepoints, the median viral load reduction was -2.6 log10 copies/mL. This far exceeds the initial targeted endpoint of ≥ 0.5 log10 viral load reduction in the phase III trial.
Importantly, a viral load below 50 copies/mL is considered undetectable and patients cannot transmit HIV.
Trogarzo® is a CD4-directed post-attachment HIV-1 inhibitor. Trogarzo®, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Before you receive Trogarzo®, tell your healthcare provider if you are pregnant or plan to become pregnant as it is not known if Trogarzo® may harm your unborn baby or if you are breastfeeding or plan to breastfeed as it is not known if Trogarzo® passes into breast milk.
Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements.
Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your health care provider right away if you start having new symptoms after starting your HIV-1 medicine.
The most common side effects of Trogarzo® include: diarrhea, dizziness, nausea, cough, fatigue and rash. These are not all the possible side effects of Trogarzo®. For more information, ask your healthcare provider or pharmacist. Full prescribing information available at www.trogarzo.com.
Theratechnologies (TSX: TH) is a commercial-stage biopharmaceutical company addressing unmet medical needs by bringing to market specialized therapies for people with orphan medical conditions, including those living with HIV. Further information about Theratechnologies is available on the Company's website at www.theratech.com and on SEDAR at www.sedar.com.
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as "may", "will", "should", "could", “would”, "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to statements regarding the sustained safety and efficacy of Trogarzo® and its use thereof.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: the safety and efficacy data observed in patients enrolled in the TMB311 study will be similar for all patients using Trogarzo®.
Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this press release. These risks and uncertainties include, among others, the risk that the safety and efficacy of Trogarzo® varies amongst patients and that untoward side-effects from the use of Trogarzo® develop over time.
We refer potential investors to the "Risk Factors" section of our annual information form dated February 20, 2019 for additional risks regarding the conduct of our business and Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date.
We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
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