GSK plc (LSE/NYSE: LON:GSK) today announced positive results from its SWIFT-1 and SWIFT-2 phase III clinical trials, demonstrating that its investigational biologic, depemokimab, significantly reduced severe asthma exacerbations. Presented at the European Respiratory Society International Conference and simultaneously published in the New England Journal of Medicine, the data showed a 54% reduction in annual exacerbation rates compared to placebo.
Depemokimab, administered biannually, targets interleukin-5 (IL-5), a key driver of type 2 inflammation in asthma. The trials involved 382 and 380 participants, respectively, who were randomized to receive either depemokimab or a placebo in addition to standard asthma care. Both studies met their primary endpoints, with the pooled analysis demonstrating a significant reduction in exacerbations (Rate Ratio 0.46, p
Additionally, the pooled data indicated a 72% reduction in exacerbations requiring hospitalization or emergency department visits. However, individual trials did not show statistically significant improvements in quality-of-life or symptom-based measures against placebo. These results are seen as a step forward in severe asthma treatment, aiming to prevent exacerbations and the associated hospitalizations, lung damage, and disease progression.
Adverse events were comparable between the depemokimab and placebo groups, with no serious events linked to the treatment. The trial period coincided with high COVID-19 prevalence, yet no significant difference in COVID-19 cases was reported between the groups.
The findings could lead to regulatory filings worldwide, though depemokimab is not yet approved in any country. GSK's development program for depemokimab also includes studies on its efficacy in other IL-5 mediated diseases.
The success of depemokimab could represent a significant advancement in the management of severe asthma by offering a long-acting treatment option that reduces the frequency of exacerbations and potentially improves patient adherence and outcomes. This information is based on a press release statement from GSK plc.
In other recent news, GSK has seen a series of significant developments. The company's respiratory syncytial virus (RSV) vaccine, Arexvy, received approval from the European Commission for use in adults aged 50-59 at increased risk of severe RSV infection. Additionally, GSK's Nucala gained approval in Japan for the treatment of chronic rhinosinusitis with nasal polyps, marking it as the first biologic in Japan with a four-weekly dosing schedule for this condition.
Furthermore, GSK's investigational treatment for chronic hepatitis B, bepirovirsen, was awarded SENKU designation by the Japanese Ministry of Health, Labour and Welfare, signifying an expedited review process due to the therapy's potential to address serious unmet medical needs. On the legal front, GSK is currently under review by the Delaware Supreme Court regarding the admissibility of expert testimony in ongoing Zantac litigation.
The company reported a 13% increase in Q2 sales to £7.9 billion and a 21% rise in core operating profit to £2.5 billion, leading to an upgraded full-year guidance. Analyst ratings have been mixed, with Deutsche Bank (ETR:DBKGn) and Berenberg reaffirming their Buy ratings on GSK, while JPMorgan (NYSE:JPM) maintained its Underweight rating.
GSK's investigational drug GSK5764227 for the treatment of extensive-stage small-cell lung cancer has been granted Breakthrough Therapy Designation by the FDA. The FDA also approved the expanded use of Jemperli, a key product in GSK's immuno-oncology portfolio, for the treatment of endometrial cancer.
InvestingPro Insights
Following GSK plc's announcement of positive trial results for depemokimab, the company's financial health and market performance remain critical for investors monitoring the potential impact on its stock value. According to recent data from InvestingPro, GSK has a robust market capitalization of $88.35 billion, reflecting investor confidence in its market position. The company's P/E ratio stands at 16.67, suggesting a reasonable valuation compared to earnings, while the adjusted P/E ratio for the last twelve months as of Q2 2024 is even more attractive at 9.84. This lower adjusted P/E ratio indicates that the company may be undervalued based on its recent earnings performance.
InvestingPro Tips highlight that GSK is a prominent player in the Pharmaceuticals industry, which may reinforce investor confidence given its successful track record and steady dividend payments for 24 consecutive years. However, investors should note that 5 analysts have revised their earnings downwards for the upcoming period, which could signal caution. On the positive side, the company's valuation implies a strong free cash flow yield, and GSK generally trades with low price volatility, providing a level of stability for shareholders. For those interested in a deeper dive into GSK's performance and future prospects, InvestingPro offers additional tips and insights at https://www.investing.com/pro/GSK.
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