ViiV Healthcare demonstrates positive findings from the phase I study of cabotegravir long-acting injectable investigational formulation

GSK plc and ViiV Healthcare, a specialized HIV company majority-owned by GSK with Pfizer and Shionogi as shareholders, announced positive phase I study results for cabotegravir ultra long-acting (CAB-ULA). This formulation allows dosing intervals of at least four months, promising significant progress in HIV treatment and prevention.

Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) in Denver, Colorado, data highlighted the safety and pharmacokinetics of CAB-ULA's intramuscular dosing, supporting longer intervals between doses. ViiV Healthcare plans a registrational study in 2024 to further assess CAB-ULA for HIV prevention.

The ongoing, open-label, single-dose, dose-escalation phase I trial evaluated cabotegravir formulations in healthy adults, showing CAB-ULA's potential for prolonged drug exposure with less frequent dosing. Additionally, a co-administration approach with recombinant human hyaluronidase PH20 was discontinued due to safety concerns.

Established in 2009, ViiV Healthcare aims to advance HIV treatment and prevention through innovative medicines and community support.