Theratechnologies presents data about tesamorelin

• 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

MONTREAL, Oct. 13, 2023 — 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.