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 May 2025
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(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: 8 May 2025, London UK
GLISTEN phase III trial results show linerixibat significantly
improves cholestatic pruritus (relentless itch) in primary biliary
cholangitis (PBC)
●
Primary
and key secondary endpoints met, demonstrating a rapid, significant
and sustained improvement in cholestatic pruritus and itch-related
sleep interference versus placebo
●
Cholestatic
pruritus presents in the majority of PBC patients, with
debilitating impacts on quality of life including sleep
disturbance
●
Late-breaking
results presented at the European Association for the Study of the
Liver (EASL) Congress 2025
__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
GSK plc (LSE/NYSE: GSK) today
announced positive results from the GLISTEN phase III trial
evaluating linerixibat, an investigational targeted inhibitor of
the ileal bile acid transporter (IBAT), in adults with cholestatic
pruritus and PBC, a rare autoimmune liver disease. The full data
were presented in a late-breaker oral presentation at the EASL
Congress 2025.
GLISTEN met the primary endpoint of change from baseline in monthly
itch score and showed linerixibat (n=119) significantly
improved itch versus placebo (n=119) over
24-weeks, as measured on a 0-10 numerical rating scale (NRS) for
the worst itch (WI-NRS) (least squares [LS] mean difference [95%
CI]: -0.72 [-1.15, -0.28], p=0.001). Monthly itch score evaluated
the worst weekly itch of each month over the 24-week treatment
period. This finding supports linerixibat's potential to address a
major symptom of PBC, relentless itch.
The trial also met key secondary endpoints including itch score at
week 2 and itch-related sleep interference NRS over 24 weeks
demonstrating:
●
Improvement in itch
was rapid with a significant improvement over placebo at week 2 (LS
mean difference [95% CI]: -0.71 [-1.07, -0.34], p<0.001) and
sustained throughout the trial.
●
Significant
improvement in itch-related sleep interference, which impacts
patient quality of life, over 24 weeks of treatment with
linerixibat compared with placebo (LS mean difference [95% CI]:
-0.53 [-0.98, -0.07], p=0.024).
●
More patients in the
linerixibat group had clinically meaningful itch improvement
(WI-NRS ≥3-point reduction) with 56% versus 43% in the
placebo group at week 24 (treatment difference 13% [95% CI 0%-27%],
nominal p=0.043).
Kaivan Khavandi, SVP, Global
Head, Respiratory, Immunology & Inflammation R&D,
GSK,
said: "Relentless
itch is present in the majority of patients with PBC and is
a symptom
that affects
sleep, mental health, and quality of life. With linerixibat, we are
one step closer to addressing the high unmet need of itch and its
related sleep interference that are critically important to
patients but historically under-treated."
The safety profile of linerixibat was consistent with previous
studies and the mechanism of IBAT inhibition, with gastrointestinal
side-effects more common in the active treatment group. The most
common adverse event, diarrhoea, was mostly mild in intensity;
discontinuation due to diarrhoea was 4% in the linerixibat group
versus <1% in the placebo group.
Gideon Hirschfield, Lily
and Terry Horner Chair in Autoimmune Liver Disease Research,
Director of the Autoimmune and Rare Liver Disease Programme at
University Health Network, Toronto and
lead author of the GLISTEN study, said: "Currently
there are very limited therapies for pruritus in PBC and previous
attempts to develop new therapies have been unsuccessful. As an
investigator who also sees many patients with PBC, and who has
worked with this molecule from the early phase II studies, the
clear improvements in itch and its related sleep interference seen
in GLISTEN are meaningful and clinically
important."
Linerixibat is
currently not approved anywhere in the world.
About cholestatic pruritus in PBC
In PBC, a cholestatic liver disease, bile flow from the liver is
disrupted. The resulting excess bile acids in circulation are
thought to play a causal role in cholestatic pruritus, an internal
itch that cannot be relieved by scratching. Pruritus can occur at
any stage of PBC disease or biochemical control, and is experienced
in varying degrees of severity by up to 90% of people living with
PBC.1 The
first line treatment for PBC controls disease in approximately 70%
of patients,2 but
does not reduce the severity or impact of the
pruritus.3 Cholestatic
pruritus is a serious condition that can be debilitating, with
patients experiencing sleep disturbance, fatigue, impaired quality
of life3 and
even sometimes requiring liver transplantation in the absence of
liver failure.4
About linerixibat (GSK2330672)
Linerixibat is an IBAT inhibitor, a targeted oral agent with
potential to treat cholestatic pruritus (itch) associated with the
rare autoimmune liver disease known as PBC. By inhibiting bile acid
re-uptake, linerixibat reduces multiple mediators of pruritus in
circulation. The US Food and Drug Administration and the European
Medicines Agency have granted orphan drug designation for
linerixibat in the treatment of cholestatic pruritus in patients
with PBC.
About the GLISTEN trial
GLISTEN is a double-blind, randomised, placebo-controlled, phase
III trial (NCT04950127; GSK study 212620) conducted in 238 PBC
patients with cholestatic pruritus initially enrolled equally into
active and placebo arms (n=119 each). The primary analysis
evaluated the efficacy and safety of linerixibat compared with
placebo. Participants with moderate to severe itch were enrolled.
Participants initially received either linerixibat or placebo and
had the potential to cross over in a part B of the trial. Primary
and secondary outcome measures were assessed using a 0-10 NRS for
worst itch and itch-related sleep interference. Stable use of
guideline suggested anti-itch therapy was permitted. The trial was
the first truly global PBC study completed in 19 countries
including the Americas, Europe, China and Japan.
About GSK research in hepatology
GSK is currently investigating multiple potential treatments for
patients with liver disease. In addition to PBC, we are also
investigating potential treatments for chronic hepatitis B,
alcohol-related liver disease (ALD), and metabolic
dysfunction-associated steatohepatitis (MASH).
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.
|
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)
|
|
|
Lyndsay
Meyer
|
+1 202
302 4595
|
(Washington
DC)
|
|
Investor
Relations:
|
Constantin
Fest
|
+44 (0)
7831 826525
|
(London)
|
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for
2024, and
GSK's Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
Footnotes
[I]
The term nominal significance refers to results with a p-value
<0.05 where there was no control for multiple comparisons or
where the test was performed after a break in the multiplicity
hierarchy.
References
1 Gungabissoon
U, et al. BMJ Open
Gastroenterol 2024;
11(1)
2 Carbone
M, et al. Lancet
Gastroenterol Hepatol. 2018
Jul 13;3(9):626-634
3. Smith 2025; Hepatol
Commun.9(3):e0635
4. Lindor KD, et al.
Hepatology. 2019;69(1):394-419
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: May
08, 2025
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GSK plc
|