Study Confirms Tesamorelin Significantly Reduces Liver Fat in HIV Patients With NAFLD
MONTREAL, April 01, 2019 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) today announced that top-line results, from a study funded by the National Institutes of Health led by Dr. Steve Grinspoon and conducted at the Massachusetts General Hospital and Harvard Medical School and the National Institutes of Health, conclude that tesamorelin significantly reduces liver fat in HIV patients with Non Alcoholic Fatty Liver Disease (NAFLD) which was the primary endpoint of the study.
Initial results reported are from the preliminary phase of a 12-month randomized, double-blind, placebo-controlled clinical trial. A total of 61 men and women with HIV infection and hepatic fat fraction ≥5%, assessed by magnetic resonance spectroscopy, were enrolled; 31 patients were randomized in the tesamorelin group while 30 patients were enrolled in the placebo group. At baseline, patients enrolled in the study had hepatic fat levels of 13.8%. In total, 43% of patients had fibrosis as assessed by liver biopsies.
The study achieved its pre-specified primary endpoint. In patients on tesamorelin, liver fat decreased by 32% while it increased by 5% in placebo patients, from baseline, (p=0.02), amounting to a 37% relative reduction in liver fat. Furthermore, 35% of patients in the tesamorelin group returned to liver fat values below 5% in comparison to only 4% of patients on placebo (p=0.007).
Secondary endpoints suggest potential benefits for fibrosis prevention as preliminary results are showing less progression with tesamorelin than placebo. More results will be made available as data analysis is completed.
NAFLD is a strong precursor of NASH which can lead to fibrosis and severe health consequences such as liver cirrhosis. It is estimated that 25% or more of HIV patients have NAFLD.1
“Findings from this study have significant clinical implications. Currently, there are no pharmacologic treatments available for NAFLD or NASH specifically proven in HIV patients, among whom NAFLD is common. While tesamorelin is not indicated for the treatment of NAFLD or NASH, the robust results obtained in this NIH-funded study clearly indicate that tesamorelin has now become a prime candidate for a potential indication in the treatment of NAFLD-NASH with further studies,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies Inc.
“Data analysis is ongoing and Theratechnologies will quickly establish a strategy regarding the potential options now available for the continued development of tesamorelin,” said Luc Tanguay President and CEO of Theratechnologies.
Tesamorelin is currently commercialized under the tradename of EGRIFTA® for the reduction of excess abdominal fat or visceral adipose tissue (VAT) in HIV-infected patients with lipodystrophy.