Image Credit: Adobe Stock Images/Sebastian Kaulitzki
GSK announced promising results from its Phase III clinical trials, SWIFT-1 and SWIFT-2, evaluating depemokimab in adults and adolescents with severe asthma characterized by type 2 inflammation and elevated blood eosinophil counts. According to the company, both trials successfully met their primary endpoint, which aimed to demonstrate a significant reduction in the annual rate of asthma exacerbations over 52 weeks.
Both trials were replicate 52-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center based, and included 375 and 380 volunteers, respectively, with depemokimab adjunctive therapy being compared to a placebo. Reportedly, depemokimab is the first ultra-long-acting biologic to be evaluated in phase III trials with a binding affinity and high potency for interleukin-5 (IL-5), resulting in the ability to dose every six-months.1
“These results add to the established body of evidence that targeted inhibition of IL-5 plays a key role in reducing type 2 inflammation that drives severe asthma exacerbations,” said Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, GSK, in a press release. “Depemokimab could offer the possibility of sustained inhibition of this pathway, with a dosing schedule of just two injections per year. This is important as research shows that 73% of physicians7 believe longer dosing intervals would be beneficial to patients who are often juggling multiple therapies.”
GSK launched the SWIFT-2 study in 2021 to measure the safety and efficacy of GSK3511294 in patients with severe eosinophilic asthma (SEA). The Phase III program also included NIMBLE, a study that focused on 1700 participants severe asthma with an eosinophilic phenotype, who are currently experiencing positive results from mepolizumab or benralizumab treatment, evaluating whether they can maintain treatment benefit when switched.2
“Around 10% of all asthma patients suffer from the avoidable symptoms of severe eosinophilic asthma and only one in four patients who are eligible for a biologic therapy currently receive one. These patients might benefit from more targeted therapies to better control their condition. We believe GSK’294 could provide another option to these patients that build on the positive impact seen with current anti-IL5 treatments and may also offer the advantage of one subcutaneous injection every six months,” said Christopher Corsico, SVP, development, GSK, in a press release.
According to the World Health Organization (WHO), asthma is the most common chronic disease among children. In 2019, it resulted in approximately 455,000 deaths, with most fatalities occurring in low- and lower-middle-income countries, citing issues with treatment and diagnoses.3
“People with under-treated asthma can suffer sleep disturbance, tiredness during the day, and poor concentration,” reports WHO. “Asthma sufferers and their families may miss school and work, with financial impact on the family and wider community. If symptoms are severe, people with asthma may need to receive emergency health care and they may be admitted to hospital for treatment and monitoring. In the most severe cases, asthma can lead to death.”
References
1. GSK announces positive results from phase III severe asthma trials of depemokimab. GSK. May 21, 2024. Accessed May 21, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-phase-iii-severe-asthma-trials-of-depemokimab/
2. GSK starts the first phase 3 study with a long-acting anti-IL-5 treatment for patients with severe asthma. GSK. March 18, 2021. Accessed May 21, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-starts-the-first-phase-3-study-with-a-long-acting-anti-il-5-treatment-for-patients-with-severe-asthma/
3. Asthma. WHO. May 6, 2024. Accessed May 21, 2024. https://www.who.int/news-room/fact-sheets/detail/asthma