November 07, 2019
Trogarzo® Remains Effective Close to a Decade After Treatment Initiation
Montreal, Canada – November 7, 2019 – Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that data presented at the 17th European AIDS Conference, currently being held in Basel, Switzerland, demonstrate that Trogarzo® (ibalizumab-uiyk) remains safe and effective in patients having been on treatment for almost a decade.
Results come from a sub-analysis of patients enrolled in study TMB-311. Patients in TMB-311 were enrolled in one of two cohorts. Cohort 1 included 12 patients rolled over from an Investigator-sponsored Investigational New Drug (PI-IND) protocol upon completion of TMB-202, a Phase 2 clinical trial of Trogarzo®. Cohort 1 also included 27 patients who had participated in the Phase 3 clinical trial TMB-301.
At time of last TMB-311 visit, all 12 patients rolled over from the Phase 2 clinical trial had an undetectable viral load. Those patients had been treated with Trogarzo® and an optimized background regimen for 7.8 years to 9.5 years (average 8.8 years).
Viral load suppression in patients rolled over from TMB-301 was achieved in close to 60 percent of participants (16/27).
TMB-311 also included 38 patients who had no prior history of treatment with Trogarzo®. Those patients were part of Cohort 2. After 48 weeks of treatment, 46% of Cohort 2 patients still on treatment achieved a viral load below 50 copies/mL (8/17).
In all cohorts, Trogarzo® was well tolerated and no ibalizumab antibodies were observed in any patient.
Trogarzo® is a CD4-directed post-attachment HIV-1 inhibitor. Trogarzo® is approved for commercialization in the United States and in the European Union. In the United States, 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) (NASDAQ: THTX) 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, on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
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, the safety and efficacy of Trogarzo®.
Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies’ control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include but are not limited to, the following: the safety and efficacy profile of Trogarzo® will be the same for all patients as reported herein, no unknown material adverse effects will be reported from the long-term use of Trogarzo® and Trogarzo® will not be subject to recalls.
The risks and uncertainties include, among others, that patients using Trogarzo® experience safety or efficacy issues different than those referred to herein and that undesired side effects are reported from the long-term use of Trogarzo® which could lead to a black-box warning or a recall of the product.
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.