Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mepolizumab 750 · 1 trial · 1 indication
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids \[OCS\], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable
| Arm | Type | Description |
|---|---|---|
| Mepolizumab 750mg | ACTIVE_COMPARATOR | Mepolizumab 750mcg i.v. every 4 weeks |
| Mepolizumab 250mg | ACTIVE_COMPARATOR | Mepolizumab 250mcg i.v. every 4 weeks |
| Mepolizumab 75mg | ACTIVE_COMPARATOR | Mepolizumab 75mcg i.v. every 4 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo saline every 4 weeks i.v. |
| Name | Type | Description |
|---|---|---|
| Mepolizumab 750 | BIOLOGICAL | Mepolizumab 750mg every four weeks by i.v. |
| Mepolizumab 250 | BIOLOGICAL | Mepolizumab 250mg every four weeks by i.v. |
| Mepolizumab 75 | BIOLOGICAL | Mepolizumab 75mg every four weeks by i.v. |
| Placebo saline | DRUG | Placebo saline every four weeks by i.v. |
Inclusion Criteria: * Male or female * Aged 12 to 65 years inclusive * Minimum weight 45kg * Clinical features of severe refractory asthma * Well documented requirement for high dose inhaled corticosteroids (ICS) \[i.e. \>= 880mcg/day fluticasone propionate or equivalent daily\] for at least 12 mon...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Mepolizumab 750 is being studied for the treatment of asthma, specifically severe asthma. It is an investigational monoclonal antibody developed by GSK plc. The clinical program has focused on patients with severe asthma, and the Phase 2 trial enrolled adolescents and adults aged 12 years and older.
Mepolizumab 750 targets interleukin-5, or IL-5. It is an inhibitor of this target. By binding IL-5, the antibody is designed to interfere with IL-5 signaling, which is a key pathway in eosinophilic inflammation associated with severe asthma. The Phase 2 trial was biomarker selected.
Mepolizumab 750 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this monoclonal antibody in respiratory disease.
Mepolizumab 750 is in Phase 2 development. It is an investigational monoclonal antibody and is not described as approved. The Phase 2 trial in severe asthma has been completed, and there are currently no active trials listed for this asset.
Mepolizumab 750 has been evaluated in the Phase 2 trial NCT01000506, titled Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma. The trial was completed, randomized, double blind, and placebo controlled, enrolling 621 participants across the United States, Europe, South America, Australia, Canada, and South Korea.