REG - GSK PLC - ContRAst phase III programme for otilimab update

GSKAnnouncement

27/10/2022 07:01

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RNS Number : 2582E  GSK PLC  27 October 2022

Issued: 27 October 2022, London UK

 

GSK provides update on ContRAst phase III programme for otilimab in the
treatment of moderate to severe

rheumatoid arthritis

 

GSK plc (LSE/NYSE: GSK) today provided an update on the ContRAst phase III
programme for otilimab, an investigational monoclonal antibody targeting
granulocyte-macrophage colony-stimulating factor (GM-CSF), in the potential
treatment of moderate to severe rheumatoid arthritis (RA). The ContRAst phase
IIl programme enrolled a broad range of difficult-to-treat patients who had an
inadequate response to or could not tolerate available treatments.

ContRAst-1 and ContRAst-2 met their primary endpoints of a statistically
significant ACR20 1  (#_ftn1) response versus placebo at week 12 in patients
with inadequate response to methotrexate (ContRAst-1) and conventional
synthetic or biologic disease modifying antirheumatic drugs (DMARDs)
(ContRAst-2).

 

Data from ContRAst-3, the third trial in the programme, did not demonstrate
statistical significance on the primary endpoint of ACR201 response versus
placebo at week 12 in patients with inadequate response to biologic DMARDs
and/or Janus Kinase inhibitors.

While the ContRAst-1 and ContRAst-2 trials met their primary endpoints, the
efficacy demonstrated is unlikely to transform patient care for this
difficult-to-treat patient population. Assessment of efficacy and safety data
from the ContRAst programme is ongoing, however the limited efficacy
demonstrated does not support a suitable benefit/risk profile for otilimab as
a potential treatment for RA. As a result, GSK has decided not to progress
with regulatory submissions. Full results from the ContRAst phase III
programme will be submitted for publication in 2023.

About the ContRAst phase III programme

The ContRAst phase III programme was designed to compare the efficacy and
safety of two doses of otilimab (90mg and 150mg subcutaneous weekly injection)
with placebo, tofacitinib (5mg capsules twice daily) and sarilumab (200mg
subcutaneous injection every other week), all in combination with methotrexate
or conventional DMARDs. The primary endpoint for each trial (ContRAst-1,
ContRAst-2 and ContRAst-3) was the proportion of patients achieving ACR20 at
week 12 (versus placebo).

About RA

RA is a chronic, systemic inflammatory condition characterised by pain, joint
swelling, stiffness, joint destruction and disability. It is estimated to
affect 24.5 million people globally. 2  (#_ftn2) Despite the use of DMARDs, a
substantial proportion of patients either fail to respond or have an
inadequate response, indicating a need for more effective treatments with an
alternative mechanism of action.

About otilimab

Otilimab (previously GSK3196165) is a fully human monoclonal antibody that
inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a protein
that plays a central role in a broad range of immune-mediated diseases,
including RA. GM-CSF acts on cells, including macrophages (an immune cell type
that plays a key role in the inflammatory process), leading to inflammation,
joint damage and pain. Otilimab neutralises the biological function of GM-CSF
by blocking the interaction of GM-CSF with its cell surface receptor. Otilimab
is not currently approved for use anywhere in the world.

GSK assumed exclusive worldwide responsibility of otilimab from MorphoSys AG
in 2013 for all development and commercialisation activities in all
therapeutic fields.

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/company
(https://www.gsk.com/en-gb/company/) .

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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 in
the Company's Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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 1  (#_ftnref1) ACR20 is defined by the American College of Rheumatology as a
20 percent improvement in both tender and swollen joint counts, plus three of
the following: patient assessments of pain, global disease activity and
physical function, physician global assessment of disease activity and acute
phase reactant (high sensitivity c-reactive protein).

 2  (#_ftnref2) GBD 2015 Disease and Injury Incidence and Prevalence,
Collaborators. "Global, regional, and national incidence, prevalence, and
years lived with disability for 310 diseases and injuries, 1990-2015: a
systematic analysis for the Global Burden of Disease Study 2015". Lancet
(2016). 388 (10053): 1545-1602.

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