Theratechnologies' IV Push Form Of HIV Treatment At Par With IV Infusion

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.