REG - GSK PLC - New ViiV LA formulation potential 4-month dosing

GSKAnnouncement

05/03/2024 07:00

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RNS Number : 5290F  GSK PLC  05 March 2024

-  Issued: 4 March 2024, London UK

 

ViiV Healthcare presents phase I clinical trial findings of a cabotegravir
long-acting injectable investigational formulation allowing at least four
months between doses

 

·   Data show for the first time a new ultra long-acting cabotegravir
formulation (CAB-ULA) that doubles the current dosing interval

·   Pharmacokinetic, tolerability and safety data supports moving CAB-ULA
to the next stage of clinical development

 

 

 

GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist
HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,
today announced positive findings from its phase I study showing that an
investigational formulation of cabotegravir, known as cabotegravir ultra
long-acting (CAB-ULA), can be dosed at intervals of at least four months. This
is the company's first step towards delivering ultra long-acting injectable
HIV treatment and prevention medicines that would potentially enable people to
have at least four months between visits to the clinic.

 

Data also showed that the intramuscular dosing of CAB-ULA has a safety and
pharmacokinetic (PK) profile that supports a longer dose interval. 1  (#_edn1)
These findings were presented today at the Conference on Retroviruses and
Opportunistic Infections (CROI 2024)
(https://www.croiconference.org/croi-2024-attendees-resources/)  2  (#_edn2) ,
in Denver, Colorado.

 

ViiV Healthcare is conducting a registrational study of CAB-ULA in 2024 to
further evaluate its use for the prevention of HIV in adults. Future areas of
study will include its potential use in combination with other medicines as a
complete, ultra long-acting HIV treatment regimen.

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.

 

Kelong Han, Ph.D., Primary Study Investigator, GSK, said: "These findings
suggest CAB-ULA has a PK profile with the potential for a dosing interval of
at least four months, which is longer than any currently approved HIV
prevention option. We look forward to the further clinical development of this
promising medicine. As we look to the future, further advancements in longer
acting medicines have the potential to revolutionise how HIV is treated and
prevented."

 

A second part of the study evaluated a variety of doses of CAB200 administered
by SC injection in 22 participants in combination with recombinant human
hyaluronidase PH20 (rHuPH20), an enzyme that enables a large amount of fluid
to be rapidly delivered by subcutaneous injection. In this part, rHuPH20
(10,000 IU) was administered first, followed by CAB200 at 800 mg, 1600 mg, and
3200 mg doses.

 

Following co-administration of CAB200 + rHuPH20, the observed CAB plasma
concentration increased proportionally with dose, and the maximum observed CAB
plasma concentration was higher than CAB200 IM alone at the same dose level,
indicating an increased initial absorption rate of the medicine. The mean
half-life for the three different CAB200 + rHuPH20 doses was similar to CAB200
IM alone, indicating a low potential to achieve less frequent dosing.

 

ISRs occurred in all participants with a dose-related trend for increased ISR
grades. One participant who received the highest CAB200 dose (3200mg) SC +
rHuPH20 experienced a drug-related serious AE of injection site erythema with
necrosis.  Based on these combined findings, ViiV Healthcare is no longer
pursuing CAB 200 SC + rHuPH20 for ultra long-acting dosing.

 

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.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com.

 

 ViiV enquiries
 Media:               Ken Inchausti      +1 732 690 6938        (Colorado)

                      Rachel Jaikaran    +44 (0) 78 2352 3755   (London)
                      Audrey Abernathy   + 1 919 605 4521       (North Carolina)
 GSK enquiries
 Media:               Tim Foley          +44 (0) 20 8047 5502   (London)
                      Sarah Clements     +44 (0) 20 8047 5502   (London)
                      Kathleen Quinn     +1 202 603 5003        (Washington DC)
                      Alison Hunt        +1 540 742 3391        (Washington DC)

 Investor Relations:  Nick Stone         +44 (0) 7717 618834    (London)
                      James Dodwell      +44 (0) 20 8047 2406   (London)
                      Mick Readey        +44 (0) 7990 339653    (London)
                      Josh Williams      +44 (0) 7385 415719    (London)
                      Camilla Campbell   +44 (0) 7803 050238    (London)
                      Steph Mountifield  +44 (0) 7796 707505    (London)
                      Jeff McLaughlin    +1 215 751 7002        (Philadelphia)
                      Frannie DeFranco   +1 215 751 4855        (Philadelphia)

 

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described under
Item 3.D "Risk factors" in the company's Annual Report on Form 20-F for 2022,
and Q4 Results for 2023.

 

Registered in England & Wales:

GSK plc
 
ViiV Healthcare Limited

No. 3888792
 
No. 06876960

 

Registered Office:

GSK
plc
ViiV Healthcare Limited

980 Great West Road                                GSK
Medicines Research Centre

Brentford, Middlesex                                  Gunnels
Wood Road, Stevenage

United Kingdom
 United Kingdom

TW8 9GS
    SG1 2NY

 1  (#_ednref1) K. Han, et al. Phase I Study of Cabotegravir Long-Acting
Injectable Formulations Supports ≥4-Monthly Dose Interval. Presented at
Conference on Retroviruses and Opportunistic Infections (CROI). March 2024.

 2  (#_ednref2) https://www.croiconference.org/croi-2024-attendees-resources/
(https://www.croiconference.org/croi-2024-attendees-resources/)

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