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Currently, maintenance doses of Trogarzo® are administered by IV infusion over 15 minutes every two weeks. Maintenance doses are prepared by diluting 4 vials of Trogarzo® (800 mg in a volume of about 5.3 mL) into a 250 mL intravenous bag of 0.9% Sodium Chloride (normal saline) and then infused.
Our partner Taimed is currently conducting a clinical study to test the safety and drug levels in blood when an 800 mg maintenance dose of Trogarzo® is administered as an undiluted IV push over 30 seconds. The drug levels of Trogarzo® using the IV Push will be compared to the drug levels of Trogarzo® after an IV infusion using the currently approved method.
Enrollment in this study is now complete and TaiMed expects to complete the trial in the third quarter of 2021. The patients will start receiving two administrations of Trogarzo® using the currently approved infusion. Subsequent administrations will be given at 800 mg undiluted via IV Push over 30 seconds.
Theratechnologies and TaiMed plan to conduct a clinical trial to evaluate an intramuscular mode of administration for Trogarzo®. The trial will be managed and financed by Theratechnologies.
Theratechnologies completed the evaluation and development of the F8 Formulation of tesamorelin, which based on internal studies, is bioequivalent to the original formulation of tesamorelin, or F1 Formulation, commercialized as EGRIFTA®. The F1 Formulation is no longer available in the United States and has been replaced by EGRIFTA SV®. The F8 Formulation has a number of advantages over the current formulation of EGRIFTA SV®, or F4 Formulation, itself bioequivalent to the Formulation F1. Specifically, it is two times more concentrated resulting in a smaller volume of administration and is intended to be presented in a multi-dose vial that can be reconstituted once per week. Similar to the current formulation of EGRIFTA SV®, the F8 Formulation is stable at room temperature, even once reconstituted.
In parallel, Theratechnologies is currently working on the development of a multi-dose pen injector to be used with the F8 Formulation. Theratechnologies intends to seek marketing approval of the pen in conjunction with the F8 Formulation. We plan to file a supplemental Biologics License Application (sBLA) for the F8 Formulation and multi-dose pen injector in early 2022 for the treatment of lipodystrophy in people living with HIV.