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 February 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: 21 February 2024, London UK
LATITUDE phase III interim trial data
indicates ViiV Healthcare's long-acting injectable HIV
treatment Cabenuva (cabotegravir + rilpivirine) has superior
efficacy compared to daily therapy in individuals living with HIV
who have adherence challenges
●
Data
Safety Monitoring Board (DSMB) for ACTG study recommends study be
modified to stop randomisation and to give participants receiving
daily oral therapy the option to transition to long-acting
injectable therapy
●
Full
data set to be presented at an upcoming scientific
conference
London, 21
February 2024 - ViiV Healthcare, the global specialist HIV company
majority owned by GSK, with Pfizer Inc. and Shionogi Limited as
shareholders, today announced results from an interim analysis of
the LATITUDE phase III trial, indicating their long-acting
injectable antiretroviral treatment (ART) for
HIV, Cabenuva (cabotegravir
+ rilpivirine), demonstrated superior efficacy in maintaining
viral load suppression compared to daily oral therapy in
individuals with a history of ART adherence
challenges.
"The interim data indicating the superiority of long-acting therapy
compared to daily oral therapy in individuals who have difficulty
taking pills for HIV every day is a remarkable
outcome," said Kimberly Smith, MD, MPH, Head
of R&D at ViiV Healthcare. "There are many reasons why people may find
it challenging to stay on daily oral treatment and the LATITUDE
study shows cabotegravir and rilpivirine injectable treatment can
help them keep their virus suppressed, which benefits their overall
health. Optimising therapy for all people living with HIV,
including those with adherence challenges, is critical to the
effort to end the HIV epidemic."
The LATITUDE (Long-Acting
Therapy to Improve Treatment Success in Daily
Life) study
is ongoing across 31 sites in the U.S. including Puerto Rico,
implemented through Advancing
Clinical Therapeutics Globally for HIV/AIDS and Other
Infections (ACTG),
a global NIH-funded clinical trials network focused on HIV and
other infectious diseases. Participants with challenges taking
daily oral ART as prescribed and evidence of viremia were screened
to ensure the HIV in their blood was not resistant to the study
drugs and that they met other health and safety criteria. Once
enrolled, they received comprehensive and incentivised adherence
support while taking guideline-recommended, three-drug regimen oral
ART, including dolutegravir and bictegravir-based regimens, to
achieve viral suppression. They were then randomised to receive
long-acting injectable ART (cabotegravir +
rilpivirine) every
four weeks or to continue taking daily oral
ART.
Last week, the DSMB performed a planned interim review. They
considered the totality of all the study endpoints together and
concluded that the evidence indicated superior efficacy of
long-acting ART over daily oral standard of care. The DSMB
recommended that all eligible participants should be offered
long-acting injectable cabotegravir +
rilpivirine.
There are many factors that can influence a person's ability to
take medicine every day, including access to health care or health
insurance, affordability, unstable housing, stigma and fear of
having their HIV status disclosed. Lack of consistent adherence is
a common reason why some people living with HIV have difficulty
maintaining undetectable viral loads.
LATITUDE is sponsored and funded by the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health, and is being conducted by ACTG, with
additional support from the National Institute of Mental Health,
the National Institute on Drug Abuse, ViiV Healthcare and the
Janssen Pharmaceutical Companies of Johnson &
Johnson.
About Cabenuva (cabotegravir +
rilpivirine)
Cabenuva is
indicated as a complete regimen for the treatment of HIV-1
infection in adults to replace the current antiretroviral regimen
in those who are virologically suppressed (HIV-1 RNA <50 c/ml)
on a stable antiretroviral regimen with no history of treatment
failure and with no known or suspected resistance to either
cabotegravir or rilpivirine.
The complete regimen combines the integrase strand transfer
inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with
rilpivirine, a non-nucleoside reverse transcriptase inhibitor
(NNRTI) developed by Janssen Sciences Ireland Unlimited Company.
Rilpivirine tablets are approved in the US as a 25mg tablet taken
once a day to treat HIV-1 in combination with other antiretroviral
agents in antiretroviral treatment-naïve patients 12 years of
age and older and weighing at least 35kg with a viral load
≤100,000 HIV RNA c/ml.
INSTIs inhibit HIV replication by preventing the viral DNA from
integrating into the genetic material of human immune cells
(T-cells). This step is essential in the HIV replication cycle and
is also responsible for establishing chronic disease. Rilpivirine
is an NNRTI that works by interfering with an enzyme called reverse
transcriptase, which stops the virus from multiplying.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.
Please consult the full Prescribing
Information: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Cabenuva/pdf/CABENUVA-PI-PIL-IFU2-IFU3.PDF
About ACTG
ACTG is the world's largest and longest running clinical trials
network focused on HIV and other infectious diseases and the people
living with them. It is funded by NIAID and collaborating NIH
Institutes. Founded in 1987, ACTG conducts research to improve the
management of HIV and its comorbidities; develop a cure for HIV;
and innovate treatments for tuberculosis, hepatitis B, and emerging
infectious diseases. It comprises thousands of dedicated
researchers, staff, and community members who are pursuing research
into novel treatments and cures for infectious diseases at hundreds
of locations across four continents, with the ultimate goal of
advancing science that meaningfully impacts the lives of the people
we serve.
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.
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James Dodwell
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+44 (0) 20 8047 2406
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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
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.
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GSK plc
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(Registrant)
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Date: February
21, 2024
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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