REG - GSK PLC - Positive phase III asthma results for depemokimab

GSKAnnouncement

21/05/2024 07:00

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RNS Number : 1898P  GSK PLC  21 May 2024

Issued: 21 May 2024, London UK

 

GSK announces positive results from phase III severe asthma trials of
depemokimab

 

·   Primary endpoints met in SWIFT-1 and SWIFT-2 trials with statistically
significant and clinically meaningful reductions in exacerbations over 52
weeks vs. placebo

·   Depemokimab has the potential to be the first approved
ultra-long-acting biologic with a six-month dosing schedule for severe asthma

·   Six-month dosing could simplify treatment to support millions of
patients with severe asthma

 

 

GSK plc (LSE/NYSE: GSK) today announced positive headline results from the
phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and
safety of depemokimab versus placebo in adults and adolescents with severe
asthma with type 2 inflammation characterised by blood eosinophil count.(1,2)
 Both SWIFT-1 and SWIFT-2 met their primary endpoints of a reduction in the
annualised rate of clinically significant exacerbations (asthma attacks) over
52 weeks.(1,2) Across both trials the overall incidence and severity of
treatment-emergent adverse events were similar in patients treated with either
depemokimab or placebo. Further analysis of these data is ongoing.

 

Depemokimab is the first ultra-long-acting biologic to be evaluated in phase
III trials with a binding affinity and high potency for interleukin-5 (IL-5),
enabling six-month dosing intervals for patients with severe asthma.(1,2,3)
IL-5 is known to be a key cytokine (protein) in type 2 inflammation.(4,5) This
inflammation, typically identified by elevated blood eosinophil count, is the
underlying pathology responsible for more than 80% of people with severe
asthma and can lead to unpredictable exacerbations.(5,6)

 

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, said:
"These results add to the established body of evidence that targeted
inhibition of IL-5 plays a key role in reducing type 2 inflammation that
drives severe asthma exacerbations. Depemokimab could offer the possibility of
sustained inhibition of this pathway, with a dosing schedule of just two
injections per year. This is important as research shows that 73% of
physicians(7) believe longer dosing intervals would be beneficial to patients
who are often juggling multiple therapies."

 

Expertise in respiratory diseases and the science of IL-5 has informed the
ongoing evidence generation program evaluating the impact of six-month dosing
of sustained IL-5 inhibition in patients achieving clinical remission in
severe asthma.(5) The full results of SWIFT-1 and SWIFT-2 will be presented at
an upcoming scientific congress and will be used to support regulatory
submissions to health authorities worldwide.

 

Depemokimab is currently not approved anywhere in the world.

 

About the depemokimab development programme

The phase III programme consists of SWIFT-1 and SWIFT-2 in severe asthma,
along with an open label extension study (AGILE).(1,2,8) SWIFT-1 and SWIFT-2
were replicate 52-week, randomised, double-blind, placebo-controlled,
parallel-group, multi-centre phase III clinical trials.(1,2) The trials
assessed the efficacy and safety of depemokimab adjunctive therapy in 375 and
380 participants who were randomised to receive depemokimab or a placebo, in
addition to their standard of care treatment with medium to high-dose inhaled
corticosteroids plus at least one additional controller.(1,2)

 

An additional study (NIMBLE) is underway to assess the efficacy and safety of
depemokimab when participants with severe asthma are switched from mepolizumab
or benralizumab.(9)

 

Depemokimab's extended half-life has the potential to provide sustained
inhibition of broad inflammatory functions and is being investigated in a
variety of type 2 inflammatory conditions.(1,2,8-13) Depemokimab is also
currently being evaluated in phase III trials across a range of other IL-5
mediated diseases, including eosinophilic granulomatosis with polyangiitis
(EGPA), chronic rhinosinusitis with nasal polyps (CRSwNP) and
hypereosinophilic syndrome (HES).(9-12)

 

About severe asthma and type 2 inflammation

Severe asthma is defined as asthma that requires treatment with high-dose
inhaled corticosteroids plus a second controller (and/or systemic
corticosteroids) or biologic therapy, to prevent it from becoming
'uncontrolled' or which remains 'uncontrolled' despite therapy.(5,14) In more
than 80% of patients with severe asthma, their condition is driven by type 2
inflammation in which patients exhibit elevated levels of eosinophils (a type
of white blood cell).(5,6) Blood eosinophils count can be measured via a
simple blood test. IL-5 is a core cytokine (protein) in type 2 inflammation
alongside IL-4 and IL-13.(5) Type 2 inflammation drives the underlying
pathology in a variety of immune-mediated conditions. IL-5 is responsible for
the growth, activity and survival of eosinophils.(5)

 

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious
treatment goals, develop the next generation standard of care, and redefine
the future of respiratory medicine for hundreds of millions of people with
respiratory diseases. With an industry-leading respiratory portfolio and
pipeline of vaccines, targeted biologics and inhaled medicines, we are focused
on improving outcomes and the lives of people living with all types of asthma
and COPD along with less understood refractory chronic cough or rarer
conditions like systemic sclerosis with interstitial lung disease. GSK is
harnessing the latest science and technology with the aim to modify underlying
disease dysfunction and prevent disease progression.

 

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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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 GSK's Annual Report on Form 20-F for 2023, and
GSK's Q1 Results for 2024.

 

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References:

1.    ClinicalTrials.gov. Placebo-controlled Efficacy and Safety Study of
GSK3511294 (Depemokimab) in Participants With Severe Asthma With an
Eosinophilic Phenotype - (SWIFT-1) Available at:
https://classic.clinicaltrials.gov/ct2/show/NCT04719832
(https://classic.clinicaltrials.gov/ct2/show/NCT04719832) Last accessed May
2024.

2.    ClinicalTrials.gov. A Study of GSK3511294 (Depemokimab) in
Participants With Severe Asthma With an Eosinophilic Phenotype (SWIFT-2)
Available at: https://classic.clinicaltrials.gov/ct2/show/NCT04718103
(https://classic.clinicaltrials.gov/ct2/show/NCT04718103) Accessed May 2024.

3.    Singh D, et al. A Phase 1 study of the long-acting anti-IL-5
monoclonal antibody GSK3511294 in patients with asthma. Br J Clin Pharmacol.
2022;88:702-712.

4.    Principe S, et al. Severe asthma: Targeting the IL-5 pathway. Clin
Exp Allergy. 2021 Aug;51(8):992-1005

5.    Global Initiative for Asthma. Global Strategy for Asthma Management
and Prevention,2024. Updated May 2024. Available at: https://ginasthma.org/
(https://ginasthma.org/) .  Accessed May 2024.

6.    Heaney L, et al. Eosinophilic and Noneosinophilic Asthma: An Expert
Consensus Framework to Characterize Phenotypes in a Global Real-Life Severe
Asthma Cohort. Chest. 2021;160(3):814-830.

7.    Research Partnership Quant uptake Market Research, 200 HCPs Top two
box on a seven-point scale where seven equaled "highly beneficial".

8.    ClinicalTrials.gov. An Open-Label Extension Study of GSK3511294
(Depemokimab) in Participants Who Were Previously Enrolled in 206713
(NCT04719832) or 213744 (NCT04718103) (AGILE). Available at:
https://clinicaltrials.gov/study/NCT05243680
(https://clinicaltrials.gov/study/NCT05243680) Last accessed May 2024.

9.    ClinicalTrials.gov. A Study of GSK3511294 (Depemokimab) Compared With
Mepolizumab or Benralizumab in Participants With Severe Asthma With an
Eosinophilic Phenotype (NIMBLE). Available at:
https://clinicaltrials.gov/study/NCT04718389
(https://clinicaltrials.gov/study/NCT04718389) Accessed May 2024.

10.  ClinicalTrials.gov. Efficacy and Safety of Depemokimab Compared With
Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis
With Polyangiitis (EGPA) Available at:
https://clinicaltrials.gov/study/NCT05263934
(https://clinicaltrials.gov/study/NCT05263934) Accessed May 2024.

11.  ClinicalTrials.gov. Efficacy and Safety of Depemokimab (GSK3511294) in
Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-1)
Available at: https://clinicaltrials.gov/study/NCT05274750
(https://clinicaltrials.gov/study/NCT05274750) Accessed May 2024

12.  ClinicalTrials.gov. Efficacy and Safety of Depemokimab (GSK3511294) in
Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)
Available at: https://clinicaltrials.gov/study/NCT05281523
(https://clinicaltrials.gov/study/NCT05281523) Accessed May 2024.

13.  ClinicalTrials.gov. Depemokimab in Participants With Hypereosinophilic
Syndrome, Efficacy, and Safety Trial (DESTINY) Available at:
https://clinicaltrials.gov/study/NCT05334368
(https://clinicaltrials.gov/study/NCT05334368) Accessed May 2024.

14.  GINA Difficult-to-treat and severe asthma in adolescent and adult
patients: diagnosis and management. Global Strategy for Asthma Management and
Prevention 2021. Available at:
https://ginasthma.org/wp-content/uploads/2021/08/SA-Pocket-guide-v3.0-SCREEN-WMS.pdf
(https://ginasthma.org/wp-content/uploads/2021/08/SA-Pocket-guide-v3.0-SCREEN-WMS.pdf)
. Accessed May 2024.

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