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TaiMed Biologics: The results pf phase 3 study of Trogarzo IV Push (study-302)

Source: TaiMed Biologics

Primary endpoints:

  • There are no serious adverse events in this study. The drug-related adverse events are mild to moderate. There are no notable safety signals on clinical laboratory parameters.

  • After IV Push with the undiluted drug Trogarzo® and IV Infusion with the diluted drug, the AUC are comparable. The 90% confidence interval of the ratio of IV Push to IV Infusion is 0.9478-1.1226, which is within the target value (0.8-1.25). The proportion of subjects with mean trough serum drug concentration equal or exceeding the target concentration are the same for both results. The p-value of the TOST (two one-sided tests of significance using Farrington-Manning method and z-statistics) is 0.0298. Both of the results suggest there are no differences in PK between IV Push and IV Infusion.

Secondary endpoints:

  • There are no differences in HIV-1 viral load due to the change from IV Infusion to IV Push.

  • No participants have an increase in plasma viral load to levels above 1,000 copies/mL on 2 consecutive measurements at least 2 weeks apart.

  • No anti-Trogarzo® antibodies detected. No immunogenicity concerns of Trogarzo®

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