Theratechnologies Announces New Data Demonstrating Tesamorelin’s Positive Effect on Immune Response Linked to Liver Inflammation

Data presented at ENDO 2021

MONTREAL, March 20, 2021 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that new data, demonstrating the positive effect of tesamorelin on the circulation of immune activation markers associated with liver inflammation, was presented today at The Endocrine Society’s annual meeting, ENDO 2021.

Dr. Takara L. Stanley, Assistant Professor of Pediatrics, Harvard Medical School, Assistant Pediatrician, Massachusetts General Hospital and Program Director, Pediatric Endocrine Fellowship Program, MGHfC, authored the poster presented at ENDO 2021.

The data comes from a sub-analysis of a double-blind, randomized, 12-month investigator-initiated trial studying the effect of tesamorelin on liver fat in 61 people infected with HIV with nonalcoholic fatty liver disease (NAFLD) which was conducted by Dr. Steven Grinspoon, Professor of Medicine, Harvard Medical School, Chief of the Metabolism Unit at Massachusetts General Hospital. Dr. Grinspoon’s findings were published in The Lancet HIV in October 2019.

The sub-analysis concludes that treatment with tesamorelin for 12 months decreased circulating markers of T-cell and monocyte/macrophage activity. A corresponding downregulation of immune pathways in the liver was also observed. These conclusions suggest that treatment with tesamorelin may contribute to better regulated immune activation in a population with metabolic dysregulation and systemic inflammation.

“The data presented at ENDO 2021 highlights tesamorelin’s unique mechanism of action that addresses the underlying cause of liver disease and further supports the Phase 3 development of this novel medicine for the potential treatment of NASH,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer at Theratechnologies. 

The presentation abstract is available at: https://www.abstractsonline.com/pp8/#!/9188/presentation/2240

Phase 3 clinical trial
The proposed Phase 3 clinical trial design will enroll participants with liver-biopsy confirmed NASH and stage 2 or 3 fibrosis. Participants will be randomized 1:1 to receive 2 mg of tesamorelin or placebo. A second liver biopsy will be performed after 18 months of treatment for the first 900 participants, approximately. These data will form the basis for filing an sBLA with the U.S. Food and Drug Administration (FDA) to seek accelerated approval. The primary endpoint used to seek accelerated approval will be the percentage of participants achieving NASH resolution and no worsening of fibrosis compared to placebo. Participants will remain in the Phase 3 trial for a total of 60 months. Subject to additional discussions with regulatory agencies, approximately 2,000 participants in total are expected to be enrolled, including a cohort of approximately 75 to 100 participants with HIV.