July 29, 2017
Theratechnologies Announces New Findings with the Investigational Antiretroviral Ibalizumab and with EGRIFTA
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Theratechnologies Inc. announced that results on HIV susceptibility to ibalizumab from the Phase IIb trial, TMB-202, along with new findings for EGRIFTA(tesamorelin for injection), were presented during poster sessions at the 9th IAS Conference on HIV Science (IAS 2017) in Paris, France.
Ibalizumab
The Phase II data for ibalizumab, a long-acting monoclonal antibody, show no significant difference in susceptibility (measured by maximum percent inhibition or ICHALFMAX Fold Change) in patient HIV isolates that were either sensitive or resistant to other antiretroviral agents, including nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors, enfuvirtide and maraviroc.
"HIV drug resistance is a key topic at the IAS conference this year, and these findings are particularly important as they suggest that ibalizumab is equally active against HIV whether it is resistant or responsive to approved antiretroviral agents," said Steve Weinheimer, Vice President, Biological Sciences at TaiMed Biologics USA. "On the heels of the BLA acceptance for priority review, these data provide additional support for ibalizumab as a potential tool for the treatment of multidrug resistant HIV-1," added Mr. Weinheimer.
EGRIFTA
In a retrospective analysis of datasets from two, multicenter, randomized placebo-controlled trials of EGRIFTA among HIV-infected adults with lipodystrophy, fat in trunk muscles decreased and trunk muscle area increased over 26 weeks in patients with excess visceral adipose tissue (VAT, abdominal fat) who had shown a clinical response to EGRIFTA (VAT decrease of 8 percent or more). These results were seen across a number of trunk muscle groups and were independent of the change in the amount of VAT for many of the measures.
"This is the first study to evaluate changes in trunk muscle fat (both abdominal and spine musculature) in HIV patients who have responded to tesamorelin," said Kristine Erlandson, MD, Assistant Professor of Medicine, Divisions of Infectious Disease and Geriatric Medicine, University of Colorado. "We are pleased to continue to uncover new information on the potential effects of tesamorelin in HIV patients with excess abdominal fat," added Dr. Erlandson.
EGRIFTA is not indicated for trunk muscle fat decrease.
About Ibalizumab
Ibalizumab is an investigational humanized monoclonal antibody being developed for the treatment of multidrug resistant HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function.
Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents.
Ibalizumab is currently under review by the FDA following the acceptance of a Biologics License Application on June 30, 2017.
About EGRIFTA
EGRIFTA is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Limitations of Use:
Do not use EGRIFTA if you:
Warnings and Precautions
Adverse Reactions
In clinical trials, the most common EGRIFTA adverse reactions occurring in >5% of patients during the 26-week main phase of the combined studies included hypersensitivity reactions, reactions due to the effect of GH including arthralgia, extremity pain, peripheral edema, and myalgia, and injection site reactions including injection site erythema and pruritis.