MONTREAL, March 08, 2019 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that new data, presented today at the 26th annual Conference on Retroviruses and Opportunistic Infections (CROI), show that Trogarzo® (ibalizumab-uiyk) injection maintains viral suppression at week 96.
Patients rolled over into the TMB-311 trial had, at baseline, a median viral load of 21,700 copies/mL. 19% of patients had a viral load ≥100,000 copies/mL. The median CD4+ cell count was 102 cells/µL.
At both week 25 and week 96, 15 of 27 patients (56%) achieved viral suppression (<50 copies/mL). At week 96, the median viral load reduction was 2.8 log10 compared to 2.5 log10 at week 25. The median CD4+ cell count increase was 45 cells/µL at week 96 in comparison to 42 cells/µL at week 25.
In addition, Trogarzo®, combined to an optimized background regimen (OBR), was still well tolerated at week 96 with no safety concerns emerging.
TMB-311 is a continuation of the pivotal of the 24-week, single-arm TMB-301 trial. The eligible 27 patients who completed TMB-301 rolled over into the TMB-311 trial to assess safety and efficacy of the treatment over a longer period of time.
Overall, the efficacy results observed at week 25 were maintained until week 96.
Efficacy in dolutegravir (DTG) and darunavir (DRV) patients in TMB-301
Trogarzo® was also shown to be effective in patients with dolutegravir (DTG) or darunavir (DRV) as part of their OBR. DTG and DRV are two commonly used antiretrovirals.
At week 25, 44% of patients resistant to DTG, achieved a viral load reduction >0.5 log10 from baseline while 82% of DTG susceptible patients reached the same reduction level.
“The increased efficacy of Trogarzo® in patients susceptible to DTG compared to DTG resistant patients is an interesting finding as it supports an earlier intervention with Trogarzo® in patients showing early signs of multidrug resistance,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies Inc.
In DRV resistant patients, 67% of patients achieved a viral load reduction >0.5 log10 from baseline while 62% of DRV susceptible patients reached the same reduction level.
About Trogarzo® (ibalizumab-uiyk) injection
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 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
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical 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.
Forward-Looking Information
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 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 efficacy observed in patients enrolled in the TMB-311 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 efficacy of Trogarzo® varies amongst patients and that untowards 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.
For media inquiries:
Denis Boucher
Vice President, Communications and Corporate Affairs
514-336-7800