Delving into the Latest Updates on Depemokimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

德莫奇单抗, GSK-294, GSK-3511294

+ [2]

Target

IL-5

Mechanism

IL-5 inhibitors(Interleukin-5 inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCardiovascular Diseases+ [4]

Active Indication

Chronic rhinosinusitis with nasal polypsEosinophilic AsthmaHypereosinophilic Syndrome+ [4]

Inactive Indication-

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline Trading Services Ltd.

GSK Plc

GlaxoSmithKline (China) Investment Co., Ltd.

+ [1]

Inactive Organization

GlaxoSmithKline Manufacturing SpA

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 42934L

Source: *****

Sequence Code 319233406H

Source: *****

主要目的（安全性）：描述12个月开放性扩展期间，嗜酸性粒细胞型重症哮喘受试者在现有哮喘治疗的基础上加用GSK3511294 100 mg（SC，每26周给药一次）的长期安全性特征。次要目的（有效性）：评价12个月开放性扩展期间，在现有哮喘治疗的基础上加用GSK3511294 100 mg（SC，每26周给药一次）长期给药对哮喘控制的一系列临床标志物和额外有效性评估的影响。其他目的：1. 描述12个月开放性扩展期间，嗜酸性粒细胞型重症哮喘受试者在现有哮喘治疗的基础上加用GSK3511294 100 mg（SC，每26周给药一次）的长期安全性特征。2. 评价GSK3511294长期给药对患者哮喘严重程度总评量表的影响。药效学（PD）目的：评价GSK3511294的长期PD效应。医疗资源利用终点目的：进一步评价GSK3511294 100 mg SC对医疗资源利用的影响。

[Translation]

Primary objective (safety): To describe the long-term safety profile of GSK3511294 100 mg (SC, once every 26 weeks) added to existing asthma treatment in subjects with eosinophilic severe asthma during the 12-month open-label extension period. Secondary objective (efficacy): To evaluate the effects of long-term administration of GSK3511294 100 mg (SC, once every 26 weeks) added to existing asthma treatment during the 12-month open-label extension period on a range of clinical markers of asthma control and additional efficacy assessments. Other objectives: 1. To describe the long-term safety profile of GSK3511294 100 mg (SC, once every 26 weeks) added to existing asthma treatment in subjects with eosinophilic severe asthma during the 12-month open-label extension period. 2. To evaluate the effects of long-term administration of GSK3511294 on the patients' asthma severity scale. Pharmacodynamic (PD) objective: To evaluate the long-term PD effects of GSK3511294. Healthcare resource utilization endpoint Objective: To further evaluate the effect of GSK3511294 100 mg SC on healthcare resource utilization.

Start Date11 Jan 2023

Sponsor / Collaborator

GlaxoSmithKline (Ireland) Ltd.

[+2]

NCT05602025

/ CompletedPhase 1

An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous Depemokimab When Delivered With a Safety Syringe Device or an Autoinjector in Healthy Adult Participants

This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.

Start Date13 Dec 2022

Sponsor / Collaborator

GSK Plc

[+1]

NL-OMON56281

/ RecruitingPhase 3

A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis) - 217095 - ANCHOR-1

Start Date12 Dec 2022

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Depemokimab

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100 Translational Medicine associated with Depemokimab

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100 Patents (Medical) associated with Depemokimab

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5

Literatures (Medical) associated with Depemokimab

01 Jan 2025·ANNALS OF INTERNAL MEDICINE

In severe asthma with an eosinophilic phenotype, depemokimab improved exacerbations, but not quality of life, at 52 wk

Article

Author: McDonald, Christine F.

CLINICAL IMPACT RATINGS:

GIM/FP/GP: [Formula: see text] Allerg & Immunol: [Formula: see text] Pulmonology: [Formula: see text].

19 Dec 2024·NEW ENGLAND JOURNAL OF MEDICINE

Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype

Article

Author: Schalkwijk, Stein ; Jackson, David J ; Howarth, Peter ; Jackson, Daniel J ; Pfeffer, Paul E ; Jacques, Loretta ; Smith, Douglas ; Pavord, Ian D ; Wechsler, Michael E ; Bernstein, David ; Korn, Stephanie ; Chen, Ruchong ; Dymek, Lucyna ; Saito, Junpei ; de Luíz Martinez, Gustavo ; Bird, Nicholas

BACKGROUND:

Depemokimab is an ultra-long-acting biologic therapy with enhanced binding affinity for interleukin-5 that may enable effective 6-month dosing intervals.

METHODS:

In these phase 3A, randomized, placebo-controlled replicate trials, we evaluated the efficacy and safety of depemokimab in patients with severe asthma and an eosinophilic phenotype characterized by a high eosinophil count (≥300 cells per microliter in the previous 12 months or ≥150 cells per microliter at screening) and a history of exacerbations despite the receipt of medium- or high-dose inhaled glucocorticoids. Patients were randomly assigned in a 2:1 ratio to receive either depemokimab (at a dose of 100 mg subcutaneously) or placebo at weeks 0 and 26, plus standard care. The primary end point was the annualized rate of exacerbations at 52 weeks. Secondary end points, which were analyzed in a hierarchical manner to adjust for multiplicity, included the change from baseline in the score on the St. George's Respiratory Questionnaire (SGRQ), the forced expiratory volume in 1 second, and asthma symptom reports at 52 weeks.

RESULTS:

Across the two trials, 792 patients underwent randomization and 762 were included in the full analysis; 502 were assigned to receive depemokimab and 260 to receive placebo. The annualized rate of exacerbations was 0.46 (95% confidence interval [CI]), 0.36 to 0.58) with depemokimab and 1.11 (95% CI, 0.86 to 1.43) with placebo (rate ratio, 0.42; 95% CI, 0.30 to 0.59; P<0.001) in SWIFT-1 and 0.56 (95% CI, 0.44 to 0.70) with depemokimab and 1.08 (95% CI, 0.83 to 1.41) with placebo (rate ratio, 0.52; 95% CI, 0.36 to 0.73; P<0.001) in SWIFT-2. No significant between-group difference in the change from baseline in the SGRQ score was observed in either trial, so no statistical inference was drawn on subsequent secondary end points. The proportion of patients with any adverse event was similar in the two groups in both trials.

CONCLUSIONS:

Depemokimab reduced the annualized rate of exacerbations among patients with severe asthma with an eosinophilic phenotype. (Funded by GSK; SWIFT-1 and SWIFT-2 ClinicalTrials.gov numbers, NCT04719832 and NCT04718103.).

01 Dec 2024·Med

Depemokimab, the first ultra-long-acting anti-IL-5 monoclonal antibody for severe eosinophilic asthma

Article

Author: Nolasco, Santi ; Crimi, Claudia

Depemokimab, the first ultra-long-acting anti-IL-5 monoclonal antibody, significantly reduced exacerbation rates in patients with severe eosinophilic asthma when administered biannually.¹ While it offers potential benefits for patient adherence and convenience, the trials showed no improvement in symptoms and lung function. Further research is needed to determine its optimal place in therapy and identify patients who will benefit the most.

29

News (Medical) associated with Depemokimab

07 Jan 2025

·www.echemi.com

Ten New Drugs Approved, Changing Medical History

According to the official announcement from the National Medical Products Administration (NMPA), Platinum Biotechnology (Beijing) Co., Ltd. has received conditional approval for its stem cell therapy "Aimi Mitosai," which is used to treat acute graft-versus-host disease (GVHD) in patients aged 14 and older, primarily affecting the digestive tract and resistant to hormone therapy. This therapy has become the first approved stem cell therapy in China. In addition, AstraZeneca's new indication application for Osimertinib has also been officially approved. This drug will be used to treat adult patients with locally advanced unresectable (stage III) non-small cell lung cancer (NSCLC) who have not shown disease progression after receiving platinum-based radical chemoradiotherapy and have epidermal growth factor receptor (EGFR) exon 19 deletion (Ex19del) or exon 21 (L858R) substitution mutations. The NMPA also announced the approval of the marketing applications for Lanapavir tablets and injections submitted by Gilead Sciences. Lanapavir is an HIV-1 capsid inhibitor that will provide a new treatment option for HIV-infected individuals who do not respond effectively to existing therapies, requiring administration only twice a year. This drug has previously been approved in the EU, the U.S., and other regions. Johnson & Johnson's innovative compound drug "Maxiten" has been submitted for marketing approval in China for the treatment of pulmonary arterial hypertension (PAH). PAH is a rare progressive and life-threatening vascular disease characterized by the constriction of small pulmonary arteries and increased pulmonary circulation pressure, which may eventually lead to right heart failure. Multiple drugs have been approved for the treatment of PAH. GlaxoSmithKline (GSK)'s depemokimab has also been submitted for marketing approval in China. Based on the progress of clinical trials, the expected indication is for severe eosinophilic asthma (SEA). Depemokimab is a new generation anti-IL-5 monoclonal antibody developed by GSK, featuring a longer half-life, high binding affinity, and potency, requiring only one injection every six months. Innovent Biologics' next-generation ROS1 tyrosine kinase inhibitor (TKI) Dabrutinib's second New Drug Application (NDA) has also been approved by the NMPA for the treatment of adult patients with ROS1-positive locally advanced or metastatic NSCLC. This approval is based on positive results from the Phase II clinical study TRUST-I (NCT04395677).

Phase 2Drug ApprovalClinical ResultCell TherapyImmunotherapy

03 Jan 2025

·endpts.com

GSK’s Nucala bags another China approval, but biggest test yet to come

GSK’s blockbuster respiratory drug Nucala has secured a China label expansion for certain patients with inflamed sinuses. But a more important challenge on the way to hitting its multibillion-dollar peak sales projections is on the horizon. Nucala could reach $2.35 billion in 2026 sales, according to GlobalData analysts. But this sky-high forecast is mainly driven by a potential new expansion in chronic obstructive pulmonary disease — the third leading cause of death worldwide. Late-stage data are still yet to be detailed, but a PDUFA date is set for May 7. On Friday, China’s NMPA greenlit the drug as an add-on to intranasal corticosteroids for people with chronic rhinosinusitis with nasal polyps (CRSwNP) that are inadequately controlled. The approval marks the third indication for Nucala in the country, following previous green lights for severe asthma and eosinophilic granulomatosis with polyangiitis. There are around 30 million people in China with CRSwNP, according to GSK. The latest approval gives them an alternative option to surgery and repeat use of oral corticosteroids, GSK’s head of respiratory and immunology R&D Kaivan Khavandi said in a release. Nucala is also approved for CRSwNP in the US, alongside other indications including severe asthma, hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis. The product reached £444 million ($550 million) in sales in the third quarter of 2024. While Nucala’s market expansion in China is welcome, the bigger commercial focus for GSK is COPD. In September, Nucala passed a Phase 3 test for the disease, which affects more than 390 million people worldwide. The drugmaker has yet to share details of the data publicly, but has already submitted them to the FDA. In December, CEO Emma Walmsley told investors at the Redburn Atlantic CEO Conference that Nucala could become “the first once-monthly biologic proven to reduce exacerbations across the full spectrum of COPD patients.” And “that’s important when you look at the competitive context here because we have included the most difficult-to-treat patients – those with emphysema, which I think is about a third of the market,” she added. Elsewhere, the company also has an ultra-long acting anti-IL-5 candidate, depemokimab, which is set to enter Phase 3 development for COPD this year. The drug has the potential to be efficacious when administered as little as once every six months, offering more convenience for patients.

Drug ApprovalPhase 3Phase 2

02 Jan 2025

·www.echemi.com

GSK's New Drug Depemokimab: One Injection Every Six Months for Asthma

According to information from the CDE website, GlaxoSmithKline (GSK) has submitted a marketing application for depemokimab in China. Considering the latest progress in clinical trials, the expected indication for this drug is severe eosinophilic asthma (SEA). Depemokimab is a new generation anti-interleukin 5 (IL-5) monoclonal antibody developed by GSK, characterized by a longer half-life, high binding affinity, and high potency, requiring only one injection every six months. In contrast, GSK's first-generation IL-5 monoclonal antibody, mepolizumab (trade name: Nucala), requires monthly injections and was approved for marketing in the United States in November 2015. According to GSK's financial report, global sales of mepolizumab were approximately $2 billion in 2023. Currently, depemokimab has completed four Phase III clinical studies targeting SEA and chronic rhinosinusitis with nasal polyps (CRSwNP). Two Phase III studies for SEA (SWIFT-1 and SWIFT-2) showed a significant reduction in the frequency of asthma attacks in the depemokimab group compared to the placebo group after 52 weeks of treatment. Similarly, two Phase III studies for CRSwNP (ANCHOR-1 and ANCHOR-2) also indicated a significant decrease in the total nasal endoscopic polyp score in the depemokimab group compared to the placebo group after 52 weeks of treatment. Additionally, the nasal congestion scores in the depemokimab group, assessed through a verbal rating scale (VRS) during weeks 49-52, also showed a significant reduction compared to the placebo group. Detailed data has not been publicly disclosed yet.

Phase 3Drug ApprovalClinical ResultBiosimilar

100 Deals associated with Depemokimab

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic rhinosinusitis with nasal polyps	NDA/BLA	CN	GlaxoSmithKline (China) Investment Co., Ltd.	04 Jan 2025
Chronic rhinosinusitis with nasal polyps	NDA/BLA	CN	GlaxoSmithKline Trading Services Ltd.	04 Jan 2025
Eosinophilic Asthma	NDA/BLA	CN	GlaxoSmithKline Trading Services Ltd.	01 Jan 2025
Eosinophilic Asthma	NDA/BLA	CN	GlaxoSmithKline (China) Investment Co., Ltd.	01 Jan 2025
Hypereosinophilic Syndrome	Phase 3	US	GSK Plc	06 Sep 2022
Hypereosinophilic Syndrome	Phase 3	CN	GSK Plc	06 Sep 2022
Hypereosinophilic Syndrome	Phase 3	JP	GSK Plc	06 Sep 2022
Hypereosinophilic Syndrome	Phase 3	AR	GSK Plc	06 Sep 2022
Hypereosinophilic Syndrome	Phase 3	AU	GSK Plc	06 Sep 2022
Hypereosinophilic Syndrome	Phase 3	BE	GSK Plc	06 Sep 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04719832 (SWIFT-1, CTgov)	Phase 3	Asthma	395	Placebo (Placebo)	bqkcaqcqbp(blvedxrmma) = ioqmfyinvn jjkhxcrhbh (rdhwyctwmj, wzgwoufnwn - btsyhrhuam) View more	-	17 Dec 2024
				GSK3511294 (Depemokimab) (GSK3511294)	bqkcaqcqbp(blvedxrmma) = xushclqris jjkhxcrhbh (rdhwyctwmj, wxsdodvhzw - dastdrohzm) View more
NCT04718103 (SWIFT-2, CTgov)	Phase 3	Asthma	397	GSK3511294 (GSK3511294)	elyjkmemqw(ltavprdpab) = kpcfpvlhbq bugqauwuvk (kiobmmjoiz, valzbempmr - valrprtgtw) View more	-	29 Nov 2024
				Placebo (Placebo)	elyjkmemqw(ltavprdpab) = blycbabubo bugqauwuvk (kiobmmjoiz, qupmimtrdl - smgnyzpsny) View more
NCT04719832 \| NCT04718103 (SWIFT-1, Pubmed \| Biospace \| N Engl J Med) Manual	Phase 3	Severe asthma	792	depemokimab (SWIFT-1)	phczwfnyeo(oogrhqhhzy) = tkermzokxo atlkfrrylo (tfoubmldgy, 0.36 - 0.58)	Positive	09 Sep 2024
				Placebo (SWIFT-1)	phczwfnyeo(oogrhqhhzy) = qggplatenc atlkfrrylo (tfoubmldgy, 0.86 - 1.43)
NCT04718103 (SWIFT-2, Company_Website) Manual	Phase 3	Severe asthma	380	Depemokimab	csbfwqnwdj(ldgepxuqkf) = statistically significant and clinically meaningful reductions in exacerbations over 52 weeks vs. placebo. ukmwftzjnb (mnbefwkzte ) Met	Positive	21 May 2024
NCT03287310 (Pubmed \| Br J Clin Pharmacol) Manual	Phase 1	Asthma	48	GSK3511294	zdhgdmktmv(yqtbrlgeqw) = no Serious Adverse Event fvgadikari (loigdaehrg ) View more	Positive	22 Jul 2021
				Placebo
NCT03287310 (CTgov)	Phase 1	Asthma	50	placebo+GSK3511294 (Placebo)	ywndbfwlct(gulnilwykp) = vvxulhlztr pgtqigybym (svpecohwrm, eonjslaqcq - gekvvdoxuc) View more	-	01 Mar 2021
				GSK3511294 (GSK3511294 2mg)	ywndbfwlct(gulnilwykp) = pefchuhisi pgtqigybym (svpecohwrm, enznfzwqen - moltaxaltg) View more