Theratechnologies, a biopharmaceutical company focused on the development and commercialisation of innovative therapies, has announced results from a study evaluating an intramuscular (IM) method of administration for Trogarzo (ibalizumab-uiyk), a monoclonal antibody antiretroviral therapy (ART) for the treatment of heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection failing their current antiretroviral regimen.
The TMB-302 study, conducted in partnership with TaiMed Biologics, enrolled 21 subjects (seven HIV-positive and 14 HIV-negative) to assess the pharmacokinetics, efficacy, and safety of IM administration of Trogarzo as compared to intravenous (IV) infusion.
Mean Trogarzo trough concentrations were greater than 15 µg/mL, suggesting that IM injection was sufficient at maintaining the drug trough concentration above the therapeutic level of 0.3 µg/mL. The mean trough concentrations were comparable between IV infusion and IM injection in HIV-positive subjects. However, the primary endpoint measuring a 90% confidence interval of the ratio of IM injection to IV infusion (0.69, 1.08) did not meet the equivalence limits (0.8, 1.25). Viral suppression, a key secondary clinical endpoint, was maintained in all HIV-positive subjects throughout the IM phase and the overall study.
Each study subject received IM maintenance doses for eight weeks of treatment and a total of 152 IM injections were administered, which were well tolerated. One subject reported injection-site pruritus (itching) at a single time point, and no subjects reported injection-site pain when Trogarzo was administered intramuscularly.
With the TMB-302 data in hand, Theratechnologies is seeking expert advice prior to completing a regulatory submission of the Trogarzo IM administration maintenance dose to the US Food and Drug Administration (FDA). The FDA is currently reviewing the company’s submission for the loading dose of the Trogarzo IV push method of administration and a decision is expected in mid-December.