GlaxoSmithKline plc ( GSK Quick Quote GSK - Free Report) announced that it has started a late-stage study, SWIFT-2, which will evaluate its anti-IL-5 monoclonal antibody candidate, GSK3511294, in patients with severe eosinophilic asthma (SEA).
The study is part of a larger phase III program that includes two other clinical studies — SWIFT- and NIMBLE — to evaluate the candidate in SEA patients. SWIFT-1 & 2 studies will evaluate the targeted anti-IL-5 therapy in patients with severe uncontrolled asthma with an eosinophilic phenotype despite treatment with standard of care. The NIMBLE study will evaluate the candidate in severe asthma patients with an eosinophilic phenotype, who are receiving treatment with either Glaxo’s approved IL-5 antagonist drug, Nucala (mepolizumab) or
AstraZeneca’s ( AZN Quick Quote AZN - Free Report) asthma drug, Fasenra (benralizumab). Moreover, patients in the NIMBLE study will continue to receive treatment with standard of care.
Glaxo believes that GSK3511294, engineered for high affinity and long-acting suppression of IL-5 function, holds potential as targeted anti-IL-5 therapies are a well-established and effective treatment approach for SEA patients. The company’s NIMBLE study may provide clarity on the safety and effectiveness of GSK3511294 compared with already approved anti-IL-5 monoclonal antibodies.
Glaxo’s shares have gained 9.4% in the past year compared with the
industry’s growth of 29.8% in that period.
Severe asthma patients whose disease is driven by inflammation of eosinophils, a type of white blood cell, have limited treatment options, mostly oral steroids. Apart from Nucala and Fasenra,
Teva Pharmaceutical’s ( TEVA Quick Quote TEVA - Free Report) Cinqair is another antibody drug that is presently marketed for SEA patients. AstraZeneca is developing a monoclonal antibody, tezepelumab, in partnership with Amgen ( AMGN Quick Quote AMGN - Free Report) in severe, uncontrolled asthma patients.
Asthma is a chronic inflammatory disease of breathlessness and has significant unmet medical need. This affects 315 million individuals worldwide and up to 10% of patients who have severe asthma, which can become uncontrolled despite receiving high doses of standard of care medicines and require the use of chronic OCS.
Meanwhile, we note that Glaxo has a strong portfolio of respiratory disorder drugs, with Trelegy Ellipta and Nucala leading the growth in this segment. The respiratory drugs generated 11% of total sales in 2020. Successful development of GSK3511294 with improved effectiveness will likely boost demand for GSK3511294, following potential commercialization, as well as bring additional revenues for Glaxo.
Glaxo carries a Zacks Rank #5 (Strong Sell).
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