UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of March 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
- 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] These
findings were presented today at the Conference
on Retroviruses and Opportunistic Infections (CROI
2024)
[2],
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
Rachel
Jaikaran
|
+1 732
690 6938
+44 (0)
78 2352 3755
|
(Colorado)
(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] 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] https://www.croiconference.org/croi-2024-attendees-resources/
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
|
GSK plc
|
|
(Registrant)
|
|
|
Date: March
05, 2024
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GSK plc
|
GSK (NYSE:GSK)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
GSK (NYSE:GSK)
Historical Stock Chart
Von Mai 2023 bis Mai 2024