Ibalizumab blocks viral entry

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:

  • The impact and safety of EGRIFTA on cardiovascular health have not been studied.
  • EGRIFTA is not indicated for weight loss management.
  • It is not known whether taking EGRIFTA? helps improve compliance with anti-retroviral medications.

    Do not use EGRIFTA if you:

  • Have pituitary gland tumor, pituitary gland surgery or other problems related to your pituitary gland.
  • Have active cancer, either newly diagnosed or recurrent, or are receiving treatment for cancer.
  • Are allergic to tesamorelin or any of the ingredients in EGRIFTA.
  • Are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA and talk with your healthcare provider.

    Warnings and Precautions

  • Neoplasms: EGRIFTA therapy should be initiated after careful evaluation of the potential benefit of treatment in patients with a history of non-malignant neoplasms or treated and stable malignancies.
  • Elevated IGF-1: IGF-1 levels should be monitored closely during EGRIFTA therapy. Careful medical consideration should be given to discontinuing EGRIFTA in patients with persistent elevations of IGF-1 levels (eg, >3 SDS).
  • Fluid Retention: Fluid retention, manifesting as increased tissue turgor and musculoskeletal discomfort, may occur during EGRIFTA therapy.
  • Glucose Intolerance: EGRIFTA treatment may result in glucose intolerance. Glucose status should be carefully evaluated prior to initiating EGRIFTA treatment and monitored periodically for changes in glucose metabolism.
  • Hypersensitivity Reactions: Hypersensitivity reactions may occur in patients treated with EGRIFTA?. In cases of suspected hypersensitivity reactions, patients should be advised to seek prompt medical attention and treatment with EGRIFTA should be discontinued immediately
  • Injection Site Reactions: EGRIFTA treatment may cause injection site reactions, including injection site erythema, pruritus, pain, irritation, and bruising.
  • Acute Critical Illness: EGRIFTA has not been studied in patients with acute critical illness. Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of growth hormone. Since EGRIFTA stimulates growth hormone production, careful consideration should be given to discontinuing EGRIFTA in critically ill patients.

    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.

    For more information about EGRIFTA, call 1-844-347-EGRIFTA or 1-844-347-4382. To report suspected adverse reactions, contact the EGRIFTA ASSIST� toll-free or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    For more information, visit www.theratech.com or www.sedar.com.

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