UK-based pharmaceutical company ViiV Healthcare has reported data from a Phase I trial of its investigational formulation, cabotegravir ultra long-acting (CAB-ULA), for HIV treatment and prevention.
The clinical data suggested that the injectable therapy could be administered at intervals of a minimum of four months to help potentially reduce clinic visits for patients.
The study demonstrated that CAB-ULA's safety and pharmacokinetic profile support the possibility of a longer dosing interval.
ViiV Healthcare plans to carry out a registrational study of CAB-ULA this year to further assess its effectiveness in preventing HIV in adults, as well as explore it in combination with other drugs as part of a complete HIV treatment regimen.
The open-label, dose-escalation Phase I trial involved 70 healthy adult participants and investigated the pharmacokinetics and safety of two cabotegravir formulations, aiming to establish their suitability for less frequent dosing.
The trial compared these formulations against the current 200mg/mL intramuscular version, CAB200, which is approved for HIV prevention and treatment.
In one part of the study, single doses of CAB-ULA were administered subcutaneously and intramuscularly to participants at various levels.
The findings showed that CAB-ULA's maximum plasma concentration was lower than that of CAB200 while its half-life was significantly longer.
CAB-ULA was found to be well-tolerated, without any adverse events leading to study discontinuation in trial subjects.
ViiV Healthcare research and development head Kimberly Smith said: “The HIV community has told us of their desire for longer-acting medicines that can help alleviate the burden of daily treatment.
“ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the HIV community.
“This new formulation of cabotegravir (CAB-ULA) with a higher concentration and at least double the half-life puts us on the path toward delivering dosing every four months for HIV treatment and PrEP.”
