Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that 20 abstracts related to Dupixent® (dupilumab) and the investigational therapy itepekimab will be presented at the European Respiratory Society (ERS) Congress 2024, taking place from September 7 to 11 in Vienna, Austria. These abstracts, which include both clinical and real-world data, were developed in collaboration with Sanofi. The presentations will highlight the potential of targeting key drivers of type 2 inflammation and other pathways to address respiratory diseases such as COPD and asthma, with the aim of improving patient outcomes. The collection includes four oral presentations.
“The breadth of our presentations at the ERS Congress demonstrates our ongoing commitment to advancing the management of challenging respiratory diseases,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President, and Chief Scientific Officer at Regeneron, who is also a principal inventor of Dupixent. “Our clinical program for Dupixent has provided us with a deep understanding of airway disease biology. We are now leveraging these insights to tackle COPD, a complex and heterogeneous condition, and we are excited about the potential of our research into Dupixent and our anti-IL-33 antibody itepekimab to support COPD patients, regardless of their smoking history.”
One of the key presentations on Dupixent at the ERS Congress will be a pooled analysis from the Phase 3 BOREAS and NOTUS trials, which investigated the treatment of uncontrolled COPD with evidence of type 2 inflammation, indicated by raised blood eosinophil levels. All patients in these trials were receiving background maximal standard-of-care inhaled therapy, with nearly all on triple therapy. The findings from BOREAS and NOTUS were instrumental in the recent European Commission approval and global regulatory submissions for Dupixent in specific patient populations with uncontrolled COPD.
According to the abstract, the pooled analysis showed that patients treated with Dupixent (n=938) experienced a 31% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks compared to placebo (n=936; nominal p<0.0001). Additional COPD data to be presented at the meeting will assess Dupixent’s impact on daily symptom frequency and severity, exacerbations, and lung function, irrespective of baseline body mass index, airflow obstruction, dyspnea (shortness of breath), and exercise capacity measures. The safety results were generally in line with the known safety profile of Dupixent in its approved indications. The most common adverse events observed with Dupixent (≥5%) compared to placebo in either COPD trial included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.
Furthermore, new research from the Phase 4 VESTIGE trial will be presented, focusing on a novel imaging study that evaluates the effects of Dupixent on airway remodeling in certain adults with asthma. Two poster presentations will provide new data on the 4-week impact of Dupixent treatment on airway inflammation, volume, flow, and mucus plugging, as well as clinical remission outcomes after 4 and 24 weeks of treatment in adults with uncontrolled moderate-to-severe asthma.
