Theratechnologies Presents Data at ID Week Showing Tesamorelin Reduces Visceral Adipose Tissue (VAT) and Liver Fat in People with HIV on Integrase Inhibitors (INSTIs)

Rhea-AI Summary

Theratechnologies presents data demonstrating that treatment with tesamorelin reduces visceral adipose tissue (VAT) and hepatic fat fraction (HFF) in people with HIV on integrase inhibitor-based regimens.

Positive

• Treatment with tesamorelin reduced VAT by 8.3% after 12 months, compared to a 10.8% increase in VAT among placebo-treated patients (p=0.0034). Tesamorelin group experienced a 31% relative reduction in HFF compared to 0% reduction for the placebo group at 12 months (p=0.006).

Negative

• None.

• Significant reduction in INSTI-associated VAT accumulation with tesamorelin contrasts with VAT increase in patients taking placebo
  

• VAT accumulation observed after 12 months on INSTI-containing regimens, even in the absence of significant weight or body mass index changes
  
• Results also show a reduction in hepatic fat fraction in people taking tesamorelin
  

^{This news release constitutes a “designated news release” for the purposes of the Company’s prospectus
supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, 2021.}

MONTREAL, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today presented data in a poster session at ID Week 2023 in Boston, Mass., demonstrating that treatment with tesamorelin significantly reduced visceral adipose tissue (VAT) and hepatic fat fraction (HFF, a measure of liver fat) in people with HIV treated with integrase inhibitor (INSTI) based regimens.

In the retrospective sub-analysis, tesamorelin reduced VAT by 8.3% after 12 months of treatment, compared to a 10.8% increase in VAT among placebo-treated patients treated with INSTIs (p=0.0034). While anthropometric measurements at baseline did not differ between the two groups, VAT increased in the placebo group (p=0.01) even in the absence of significant weight or BMI changes. Furthermore, the tesamorelin group experienced a 31% relative reduction in HFF compared to a 0% reduction for the placebo group at 12 months (p=0.006).

“Our study sub-analysis shows that tesamorelin effectively reduces visceral and hepatic fat in people with HIV on integrase inhibitor-based regimens – one of the most common classes of antiretroviral drugs for the treatment of HIV,” said study investigator Lindsay Fourman, M.D., Assistant Professor of Medicine in the Metabolism Unit at Massachusetts General Hospital and Harvard Medical School. “Accordingly, tesamorelin may be effective in countering gains in adiposity that commonly occur with integrase inhibitors.”

Tesamorelin, a growth hormone-releasing hormone analog, has been shown to reduce VAT by more than 15% over six months in persons with HIV with excess visceral abdominal fat. That finding prompted the latest analysis, in which investigators reviewed data from a previous placebo-controlled trial of 61 patients with HIV-associated non-alcoholic fatty liver disease (NAFLD). Amongst participants, 39 (64%) were on INSTI-containing regimens, the most common of which was dolutegravir (41%). Those individuals were largely similar at baseline to those on regimens without INSTIs, including their VAT and HFF.

“As we learn more about the mechanisms of rapid weight gain and, in particular, visceral fat accumulation in people with HIV who are on integrase inhibitors, potential treatment strategies will become more important,” commented Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “Tesamorelin remains the only FDA-approved therapy to treat excess abdominal fat in adults with HIV, and these data are yet another key piece in highlighting its efficacy in modern HIV management.”

Complete abstract and poster details are available on the Company’s website.

About Theratechnologies

Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on LinkedIn and Twitter.

Forward-Looking Information

This press release contains forward-looking statements and forward-looking information (collectively, the “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", “promising”, “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 efficacy of tesamorelin for the reduction of VAT and HFF. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on this information since actual results may vary from the Forward-Looking Statements. Certain assumptions made in preparing the Forward-Looking Statements include that: participants in the study may or may not have been responders to the taking of tesamorelin; results observed in study subjects may or may not be generally observed in people with HIV treated with integrase inhibitor based regimens; and there may be unknown side effects of tesamorelin in people with HIV treated with integrase inhibitor based regimens. Forward-Looking Statements 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 Statements. These risks and uncertainties include, but are not limited to, those related to or arising from: the safety and efficacy results observed in the conduct of the study may vary among people with HIV treated with integrase inhibitor based regimens. We refer current and potential investors to the “Risk Factors” section of our Annual Information Form dated February 27, 2023, available on SEDAR at www.sedarplus.ca and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 28, 2023, under Theratechnologies’ public filings for additional risks involved in our business. 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.

Contacts:

Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800

Investor inquiries:
Phillipe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
438-315-6608

FAQ

What did the study show about tesamorelin treatment?

The study showed that treatment with tesamorelin significantly reduced visceral adipose tissue (VAT) and hepatic fat fraction (HFF) in people with HIV on integrase inhibitor-based regimens.

What were the specific reductions observed in VAT and HFF?

After 12 months, tesamorelin reduced VAT by 8.3% compared to a 10.8% increase in VAT among placebo-treated patients. The tesamorelin group experienced a 31% relative reduction in HFF compared to 0% reduction for the placebo group.

What is tesamorelin used for?

Tesamorelin is an FDA-approved therapy to treat excess abdominal fat in adults with HIV.

What are integrase inhibitors?

Integrase inhibitors are a common class of antiretroviral drugs used for the treatment of HIV.

Where can I find more details about the study?

Complete abstract and poster details are available on Theratechnologies' website.