GSK Initiates Phase 3 Clinical Trials of GSK294, a Long-Acting Anti-IL-5 Biologic Administered Once Every Six Months for Severe Eosinophilic Asthma

March 19, 2021 /BioValleyBIOON/ --GlaxoSmithKline(GSK) recently announced the evaluation of the anti-inflammatory drug GSK3511294 (GSK294) for the treatment of severe eosinophilicAsthmaThe SWIFT-2 trial for (SEA) has treated the first patient. This trial is part of a Phase 3 clinical program evaluating the efficacy and safety of GSK294 in treating SEA.

GSK294 is an investigational anti-IL-5 monoclonal antibody being developed for the treatment of severe eosinophilic asthma (SEA). It has the potential to become the first biologic agent administered via subcutaneous injection every six months, providing long-term IL-5 inhibition in patients with SEA.

GSK294 is a unique, novel biological entity designed to provide high-affinity, long-acting inhibition of IL-5 function. IL-5 is the primary cytokine regulating eosinophil proliferation, activation, and survival, and has been confirmed as a therapeutic target in patients with severe asthma characterized by elevated eosinophil levels. For severe eosinophilicAsthma(SEA) patients, targeted anti-IL-5 therapy is a recognized and effective treatment method.

Christopher Corsico, Senior Vice President of Development at GSK, stated: “Approximately 10% of asthma patients suffer from severe eosinophilicAsthma(SEA), currently only one-quarter of patients eligible for biologic therapy have received such treatment. These patients may benefit from more targeted therapies to better control their condition. We believe GSK294 has the potential to provide an alternative option for patients who have responded positively to current anti-IL-5 treatments, and may offer the advantage of subcutaneous injection once every six months.”

Over a period of 3.5 years, the GSK294 project rapidly advanced from Phase I to Phase III clinical trials. The Phase III program will comprise three studies involving 2,450 patients to evaluate the efficacy and safety of GSK294.

SWIFT 1 (N=375) and SWIFT 2 (N=375) will evaluate the efficacy and safety of GSK294 in patients with eosinophilic asthma whose condition remains uncontrolled despite standard care with medium-to-high dose inhaled corticosteroids and at least one additional medication. NIMBLE (N=1,700) will assess whether patients with severe eosinophilic asthma who are currently benefiting from treatment with Nucala (mepolizumab) or Fasenra (benralizumab) can maintain therapeutic effects after switching to GSK294. Throughout the studies, all patients will continue their baseline standard of care with non-biologic agents.AsthmaTreatment.

Severe asthma refers to asthma that requires treatment with medium-to-high doses of inhaled corticosteroids (ICS) plus a second controller medication (and/or systemic corticosteroids) to prevent it from becoming “uncontrolled,” or remains “uncontrolled” despite such therapy. Patients with severe asthma are also frequently categorized based on long-term use of oral corticosteroids (OCS). Eosinophils are involved in more than 50% of severe cases.Asthmaplays a central role in patients, providing a reliable target for treatment.

Nucala isGlaxoSmithKlinean IL-5 inhibitor, first approved in late 2015, is the world’s first biologic therapy targeting IL-5. Fasenra isAstraZenecaan IL-5 inhibitor. Both of these IL-5 inhibitors have been approved for the treatment of severe eosinophilicAsthma(SEA). (Bioon.com)

Original Source: GSK starts the first phase 3 study with a long-acting anti-IL-5 treatment for patients with severe asthma