- Theratechnologies Inc THTX has announced results from a study evaluating an intravenous (IV) push form of Trogarzo (ibalizumab-uiyk) for HIV-1 infection.
- The TMB-302 study was conducted by the Company's partner, TaiMed Biologics, to evaluate the current Trogarzo IV Infusion with a more convenient IV Push form that can be infused within 30 seconds without dilution to the 15-minute infusion time of the original IV Infusion.
- Data showed consistent and statistically significant results demonstrating no difference in pharmacokinetics between IV Push and IV Infusion.
- The proportion of subjects with mean trough serum drug concentration equal or exceeding the target concentration was also the same for both administration forms.
- Additionally, no serious adverse events were observed, and drug-related adverse events were considered mild to moderate.
- The Company plans to file a supplemental application with the FDA in Q4 of 2021.
- 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 antibodies or immunogenicity concerns.
- Theratechnologies and TaiMed are currently evaluating an intramuscular (IM) method of administration for Trogarzo.
- Patient screening is planned for Q4 of 2021.
- Price Action: THTX shares are up 2.80% at $3.67 during the market session on the last check Wednesday.
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