Pharmaceutical firm Theratechnologies has announced the pharmacokinetics (PK) and pharmacodynamics (PD) data comparing the intramuscular (IM) with the intravenous (IV) administration of ibalizumab.
The PK and PD of two doses of ibalizumab, 800mg bi-weekly and 2,000mg every four weeks and administered IM were analysed under study TMB-121.
This data was compared to the PK and PD data of similar doses of ibalizumab administered IV from an earlier study.
The results indicated that the profiles of PK and PD of both doses of ibalizumab administered IM were comparable with IV profiles.
Ibalizumab was found to be well tolerated when administered with IM or IV.
TMB-121 is a Phase I/II, randomised trial to evaluate PK / PD of IM administration of ibalizumab.
The trial is being carried out in Taiwan by the firm's partner TaiMed Biologics and has seen the enrolment of patients with HIV-1 RNA greater than 5,000 copies/mL who have not received anti-retroviral (ARV) treatment for at least one year.
The primary aim of this trial is to analyse the PK and PD profile of ibalizumab when administered by different routes of administration.
Ibalizumab is an investigational humanised monoclonal antibody presently being developed for the potential treatment of multiple drug-resistant human immunodeficiency virus-1 (MDR HIV-1) infection.
Ibalizumab is unlike other anti-retroviral agents and links primarily to the second extracellular domain of the CD4+ T-cell receptor, away from major histocompatibility complex II molecule binding sites.
While preserving normal immunological function, it potentially prevents HIV from infecting CD4+ immune cells.
Ibalizumab is active against HIV-1 resistant to all approved anti-retroviral agents.
Ibalizumab has gone through Phase I and II clinical trials. The Phase III trial is the last important clinical study required for the completion of a Biologics License Application (BLA), which is expected to be submitted to the Food and Drug Administration (FDA).