Benzinga | Sep 22, 2021 08:12AM EDT

Theratechnologies Announces Results For Trogarzo IV Push Administration; Says TMB-302 Study Results Demonstrate There Was No Difference In Pharmacokinetics Between IV Push And IV Infusion

Theratechnologies Inc. (Theratechnologies, or Company) (TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that a study evaluating an intravenous (IV) push form of administration of Trogarzo(r) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection achieved consistent and statistically significant results demonstrating that there was no difference in pharmacokinetics (PK) between IV Push and IV Infusion. Based on these results, a supplemental Biologics License Application (sBLA) is expected to be filed with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021.

The TMB-302 study was conducted by the Company's partner, TaiMed Biologics (TaiMed), to evaluate the safety and comparability of the current Trogarzo(r) IV Infusion mode of administration with a more convenient IV Push form of administration that can be infused within 30 seconds without dilution compared to the 15-minute infusion time of the original IV Infusion.

"These results confirm that the IV Push method of administration of Trogarzo(r) is an effective alternative to the current IV Infusion administration," said Paul Levesque, President and Chief Executive Officer of Theratechnologies. "This more convenient IV Push mode of administration also offers patients a rapid infusion time and requires only two quick infusions per month. We are confident that this faster infusion may further increase patient compliance, allowing patients to benefit from long-acting protection against HIV-1 when Trogarzo(r) is administered with other antiretrovirals."

The primary endpoint measuring a 90% confidence interval of the ratio of IV Push to IV Infusion was within the target value. The proportion of subjects with mean trough serum drug concentration equal or exceeding the target concentration was also the same for both forms of administration. Additionally, there were no serious adverse events observed and drug-related adverse events were considered mild to moderate.

Secondary endpoints were also achieved confirming no difference in HIV-1 viral load due to the change from IV Infusion to IV Push. Additionally, there were no anti-Trogarzo(r) antibodies or immunogenicity concerns of Trogarzo(r) detected.

Theratechnologies and TaiMed are currently evaluating an intramuscular (IM) method of administration for Trogarzo(r) as part of the TMB-302 study with patient screening planned for the fourth quarter of 2021. The study will be conducted and funded by Theratechnologies with support from TaiMed.

Under the terms of the agreement with TaiMed, Theratechnologies is entitled to commercialize the new IV Push and IM methods of administration of Trogarzo(r) if, and when, approved.