GSK announces start of Phase lll programme for mepolizumab in severe refractory asthma

GlaxoSmithKlineGlaxoSmithKline plc (GSK) has announced the start of a Phase III programme to evaluate the efficacy and safety of mepolizumab, an investigational IL-5 antagonist, as adjunctive therapy in severe uncontrolled refractory asthma. The Phase III programme includes two key studies:
  • MEA115588: A 32-week multicentre, randomised, double-blind, double-dummy, placebo-controlled study in patients with severe uncontrolled refractory asthma. The primary endpoint of the study is to evaluate the efficacy of mepolizumab 75 mg intravenous (i.v.) and 100 mg subcutaneous (SC) every 4 weeks versus placebo on the frequency of clinically significant exacerbations in patients with severe refractory asthma.
  • MEA115575: A 24-week randomised, double-blind, placebo-controlled, parallel-group, multicentre study to evaluate the use of mepolizumab 100mg subcutaneous adjunctive therapy every 4 weeks to reduce steroid use in patients with severe refractory asthma.

The Phase III programme also includes safety extension trials that will further assess treatment of subsequent asthma attacks in mepolizumab-naive as well as previously-treated patients.

"The progression of this Phase III programme represents a significant milestone in the clinical development of mepolizumab as a potential treatment option for patients with severe uncontrolled refractory asthma," commented Steve Yancey, Vice-President and Head of the mepolizumab development team.

About mepolizumab
Mepolizumab is an investigational fully humanised IgG monoclonal antibody specific for interleukin 5 (IL-5) which is in development for severe refractory asthma in patients who exacerbate despite high-dose inhaled (ICS) or oral corticosteroids (OCS) and long-acting beta-2 agonist use. IL-5 is a cytokine which regulates the growth, activation and survival of eosinophils (white blood cells) and provides an essential signal for the movement of eosinophils from the bone marrow into the lung. Mepolizumab binds to human IL-5, stopping it from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this manner reduces blood, tissue and sputum eosinophil levels, which in turn reduces the frequency of exacerbations. Mepolizumab is not approved for use anywhere in the world.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Most Popular Now

Scientists uncover SARS-CoV-2-specific T cell immu…

The study by scientists from Duke-NUS Medical School, in close collaboration with the National University of Singapore (NUS) Yong Loo Lin School of Medicine, Singapore Ge...

Common FDA-approved drug may effectively neutraliz…

A common drug, already approved by the Food and Drug Administration (FDA), may also be a powerful tool in fighting COVID-19, according to research published this week in ...

Neutralizing antibodies isolated from COVID-19 pat…

Researchers at Columbia University Irving Medical Center have isolated antibodies from several COVID-19 patients that, to date, are among the most potent in neutralizing ...

Another mRNA-based vaccine candidate protects anim…

An experimental messenger RNA (mRNA)-based vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) elicits protective immune responses in mice and no...

GSK and CureVac announce strategic mRNA technology…

GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialis...

Pfizer and BioNTech granted FDA Fast Track designa…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, "BioNTech") announced that two of the companies' four investigational vaccine candidates from their BNT162 mRNA-bas...

Novartis launches first-of-its-kind not-for-profit…

Novartis announced a new initiative to help patients in low-income and lower-middle-income countries (LIC; LMIC) access affordable medicines to treat the major symptoms o...

COVID-19 vaccine AZD1222 showed robust immune resp…

Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD1222 was tolerated and generated robust immune responses against the SARS-Co...

Pfizer and BioNTech announce an agreement with U.S…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of...

Pfizer and BioNTech choose lead mRNA vaccine candi…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate a singl...

Experimental COVID-19 vaccine protects upper and l…

Two doses of an experimental vaccine to prevent coronavirus disease 2019 (COVID-19) induced robust immune responses and rapidly controlled the coronavirus in the upper an...

Pfizer and BioNTech announce agreement with the Un…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candid...