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.
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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.
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The trial compared these formulations against the current 200mg/mL intramuscular version, CAB200, which is approved for HIV prevention and treatment.
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By GlobalDataIn 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.”
