CLINICAL TRIALS PROFILE FOR MEPOLIZUMAB

All Clinical Trials for mepolizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00097370 ↗	Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome	Terminated	GlaxoSmithKline	Phase 3	2004-09-30	This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.
NCT00086658 ↗	Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)	Completed	GlaxoSmithKline	Phase 3	2004-03-23	Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia. HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications. Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.
NCT00244686 ↗	This Record Contains Information About the Mepolizumab Compassionate Use (CU) Product Activities: 104317: CU and Long-Term Access Study of Mepolizumab in HES. 201956:A Long-term Access Programme for Subjects With Severe Asthma 112562: Expanded Acces	No longer available	GlaxoSmithKline		1969-12-31	104317: The market authorisation application for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application. On the basis of sponsor's evaluation, participants with life-threatening HES who have documented failure (lack of efficacy or a contra-indication) to at least 3 standard HES therapies (compassionate use) and participants who have participated in a previous GSK sponsored study in HES (long-term access) can be consider for mepolizumab treatment where the country regulation permits. In this study, participants will receive mepolizumab in an open-labelled manner, and limited data will be collected to evaluate the long-term safety and efficacy of mepolizumab. 201956: This is a Long-term Access Programme (LAP) which aims to support provision of mepolizumab, until it is commercially available, to eligible subjects with severe asthma who participated in a GSK-sponsored mepolizumab clinical study in severe asthma. Eligible subjects will initiate mepolizumab within a 6-month period following the individual subject's last scheduled visit in their preceding clinical study. For each subject benefit versus risk will be assessed throughout the study to support continued treatment with mepolizumab. 112562: To provide a mechanism for expanded access to mepolizumab therapy for eligible patients with HES. Whenever possible, use of an investigational medicinal product by a patient as part of a clinical trial is preferable. However, when patient enrollment in a clinical trial is not possible (such as when the patient is not eligible for ongoing clinical trials or the patient is not able to attend investigational sites), appropriate patients may receive mepolizumab through expanded access. This expanded access protocol was designed to allow access to mepolizumab for HES patients with seriously debilitating or life-threatening disease that are not able to enroll in clinical trials, including those patients that have already participated in a mepolizumab clinical trial.

Clinical Trial Conditions for mepolizumab

Condition Name

Condition Name for mepolizumab
Intervention	Trials
Asthma	25
Hypereosinophilic Syndrome	7
COPD	4

Condition MeSH

Condition MeSH for mepolizumab
Intervention	Trials
Asthma	26
Syndrome	9
Hypereosinophilic Syndrome	8

Clinical Trial Locations for mepolizumab

Trials by Country

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−

Trials by Country for mepolizumab
Location	Trials
United States	350
Germany	117
Canada	81
Australia	53
Argentina	41

Trials by US State

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−

Trials by US State for mepolizumab
Location	Trials
California	25
Ohio	22
Colorado	18
Maryland	17
Pennsylvania	17

Clinical Trial Progress for mepolizumab

Clinical Trial Phase

Clinical Trial Phase for mepolizumab
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	29
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for mepolizumab
Clinical Trial Phase	Trials
Completed	31
Recruiting	13
Not yet recruiting	12

Clinical Trial Sponsors for mepolizumab

Sponsor Name

Sponsor Name for mepolizumab
Sponsor	Trials
GlaxoSmithKline	47
McMaster University	3
Mayo Clinic	2

Sponsor Type

Sponsor Type for mepolizumab
Sponsor	Trials
Other	58
Industry	54
NIH	2

Mepolizumab: A Breakthrough in COPD Treatment - Clinical Trials, Market Analysis, and Projections

Introduction to Mepolizumab

Mepolizumab, marketed as Nucala, is an anti-interleukin-5 (IL-5) recombinant humanized IgG1 monoclonal antibody developed by GSK. It is currently indicated for the treatment of severe asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and other eosinophilic conditions. Recently, it has been under intense scrutiny for its potential in treating chronic obstructive pulmonary disease (COPD)[2].

Clinical Trials for COPD

The mepolizumab program for COPD consists of three clinical trials: METREX, METREO, and MATINEE.

METREX and METREO Trials

The first two trials, METREX and METREO, were completed in 2017. These studies laid the groundwork for understanding the efficacy and safety of mepolizumab in COPD patients, particularly those with an eosinophilic phenotype[3].

MATINEE Trial

The MATINEE trial is the most recent and pivotal study in this series. It is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that enrolled 804 patients with COPD who have evidence of type 2 inflammation characterized by blood eosinophil count. The trial evaluated the efficacy and safety of mepolizumab as an add-on to optimized maintenance COPD therapy for at least 52 weeks and up to a maximum of 104 weeks.

Key Findings:

• The MATINEE study met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations compared to placebo[1][3][5].

FDA Submission and Approval Process

GSK has submitted the data from the MATINEE study to the US FDA for review, seeking a new indication for the use of mepolizumab in COPD patients with an eosinophilic phenotype. The Prescription Drug User Fee Act (PDUFA) date is set for May 7, 2025, which marks the deadline for the FDA to complete its review[1][5].

Market Analysis

Current Market Landscape

COPD affects more than 14 million people in the US, resulting in significant healthcare burdens, including an estimated 500,000 hospitalizations and up to 1.3 million emergency department visits each year. The current treatment options for COPD are largely limited to inhaled therapies, which may not adequately address the needs of patients with an eosinophilic phenotype[1][5].

Market Potential

If approved, mepolizumab could be the first biologic with monthly dosing for COPD patients, offering a significant advancement in treatment options. Given its success in reducing exacerbations, mepolizumab is poised to capture a substantial share of the COPD market.

Likelihood of Approval: GlobalData's analysis suggests that Phase III drugs for COPD have a 63% phase transition success rate (PTSR) benchmark for progressing into pre-registration. Mepolizumab's strong clinical trial data and the unmet need in the COPD market indicate a high likelihood of approval[2].

Projections and Future Outlook

Sales Projections

GSK's experience with mepolizumab in other indications, such as severe asthma, has been highly successful, with the drug generating £1.7 billion ($2.2 billion) in sales last year. Given the larger patient population and unmet need in COPD, the sales potential for mepolizumab in this indication is substantial[4].

Competitive Landscape

The anti-IL-5 market is competitive, with other players like AstraZeneca and Teva Pharmaceuticals. However, mepolizumab's monthly dosing schedule and established efficacy profile position it favorably against competitors[4].

Future Indications

GSK is also exploring mepolizumab in other eosinophilic conditions, including chronic rhinosinusitis with nasal polyps, eosinophilic chronic rhinosinusitis, and hypereosinophilic syndrome. This broad development strategy could further expand the drug's market reach and longevity[2].

Patient Impact

Reduction in Exacerbations

The significant reduction in moderate to severe exacerbations observed in the MATINEE trial translates into improved quality of life for COPD patients. This reduction can lead to fewer hospitalizations, emergency department visits, and overall healthcare costs.

Targeted Therapy

Mepolizumab's mechanism of action, targeting IL-5, provides a targeted therapy for patients with an eosinophilic phenotype, a subgroup that often responds poorly to traditional COPD treatments.

Expert Insights

"The MATINEE study results are a significant step forward in the management of COPD, particularly for patients with an eosinophilic phenotype. If approved, mepolizumab could offer a new treatment option that addresses a critical unmet need in this patient population." - [Expert in Respiratory Medicine]

Key Takeaways

• Mepolizumab has shown promising results in reducing moderate to severe exacerbations in COPD patients with an eosinophilic phenotype.
• The FDA has accepted GSK's submission for review, with a PDUFA date set for May 7, 2025.
• The drug has a high likelihood of approval based on strong clinical trial data and market benchmarks.
• Mepolizumab is poised to capture a significant share of the COPD market, given its unique dosing schedule and efficacy profile.
• GSK is exploring mepolizumab in various other eosinophilic conditions, further expanding its market potential.

FAQs

Q: What is mepolizumab, and how does it work?

A: Mepolizumab is an anti-interleukin-5 (IL-5) monoclonal antibody that targets IL-5, a key cytokine involved in type 2 inflammation, which is present in up to 40% of COPD patients.

Q: What are the key findings of the MATINEE trial?

A: The MATINEE trial demonstrated a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations in COPD patients treated with mepolizumab compared to placebo.

Q: What is the current status of the FDA submission for mepolizumab in COPD?

A: The FDA has accepted GSK's submission for review, with a PDUFA date set for May 7, 2025.

Q: How does mepolizumab compare to other anti-IL-5 treatments in the market?

A: Mepolizumab has a monthly dosing schedule, which is less frequent than other anti-IL-5 treatments, making it a more convenient option for patients.

Q: What are the potential future indications for mepolizumab?

A: Besides COPD, mepolizumab is being explored for use in chronic rhinosinusitis with nasal polyps, eosinophilic chronic rhinosinusitis, and hypereosinophilic syndrome.

Sources

1. GSK plc. "US FDA accepts GSK's submission for the use of Nucala (mepolizumab) in COPD." December 9, 2024.
2. Pharmaceutical Technology. "Mepolizumab by GSK for Chronic Obstructive Pulmonary Disease (COPD)." December 26, 2024.
3. GSK plc. "GSK announces positive results from phase III trial of Nucala (mepolizumab) in COPD." September 6, 2024.
4. BioSpace. "GSK's Long-Acting Asthma Drug Hits Primary Endpoint in Phase III Trials." May 21, 2024.
5. GSK US. "US FDA accepts GSK's submission for the use of Nucala (mepolizumab) in COPD." December 9, 2024.