ViiV HEALTHCARE PRESENTS PHASE I CLINICAL TRIAL FINDINGS OF A CABOTEGRAVIR LONG-ACTING INJECTABLE INVESTIGATIONAL FORMULATION ALLOWING AT LEAST FOUR MONTHS BETWEEN DOSES

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, 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 at every four months for HIV treatment and PrEP.”

The ongoing, open-label, single-dose, dose-escalation phase I study in 70 healthy adults evaluated the safety and PK of two different formulations of cabotegravir and their potential for less frequent dosing. To evaluate the long-acting potential of these regimens, their PK profiles were compared against the 200 mg/mL intramuscular formulation of cabotegravir (CAB200), which is currently approved for the prevention of HIV by itself or for the treatment of HIV (when combined with rilpivirine).

One part of the study evaluated single doses of CAB-ULA administered subcutaneously (SC) in 16 participants or intramuscularly (IM) in 32 participants at doses of 800 mg, 1200 mg, and 1600 mg. The maximum observed plasma concentration of CAB-ULA, regardless of route of administration, was lower than CAB200 IM at the same dose level, indicating slower absorption of CAB-ULA. The projected half-life (measure of time the drug stays in the body) of CAB-ULA (SC) and CAB-ULA (IM) was six times greater and two times greater, respectively, than the half-life of CAB200 IM. PK simulations enabled researchers to predict that a 1600 mg/3mL IM dose of CAB-ULA administered every four months or greater could potentially achieve a similar level of medicine exposure compared to the approved 600 mg/3mL IM dose of CAB200, which is administered every two months.

Administration of CAB-ULA was well tolerated with no adverse events (AEs) leading to participant study discontinuation. All participants who received SC doses of CAB-ULA reported injection site reactions (ISRs), while 22/32 who received IM doses reported ISR events. The majority of IM ISRs were mild pain (grade 1) that lasted less than 7 days. Even though dosing in this study was higher than the currently approved CAB200 IM, the CAB-ULA IM ISR profile appeared comparable to the established CAB200 IM ISR profile.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.