Regeneron, Sanofi announce Dupixent outperformed Xolair
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) presented positive results from the EVEREST Phase 4 trial in adults with severe chronic rhinosinusitis with nasal polyps and coexisting asthma. In the trial, Dupixent outperformed Xolair on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints. The data are from the first-ever presented head-to-head respiratory trial with biologic medicines and were shared in a late-breaking oral presentation at the 2025 European Academy of Allergy and Clinical Immunology, EAACI, Annual Congress. Results reinforce the efficacy of Dupixent in treating both upper and lower respiratory diseases by targeting IL-4 and IL-13, two key drivers of type 2 inflammation
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Medscape
6 hours ago
- Medscape
Head-to-Head Trial Finds Winner for CRSwNP With Asthma
Dupilumab significantly outperformed omalizumab in reducing the size of nasal polyps and improving sense of smell in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma, according to the head-to-head EVEREST phase 4 biologics trial . The study is the first to demonstrate the superiority of dupilumab over omalizumab across both upper and lower airway disease outcomes — resulting in a significant reduction in nasal polyp score and a greater improvement in pre-bronchodilator forced expiratory volume 1. The two therapies had generally similar safety profiles, according to the researchers. "The data provide important insights that can help guide patients and physicians through the treatment decision-making process,' said Eugenio De Corso, MD, ENT specialist at the A. Gemelli University Hospital Foundation, Rome, Italy, who presented the findings at the 2025 annual congress of the European Academy of Allergy and Clinical Immunology. 'Dupilumab also demonstrated nominally greater improvements in asthma-related endpoints, including lung function and asthma control, compared to omalizumab.' De Corso said that the results do not change the approved indications for dupilumab and do not support starting treatment with the drug earlier in the course of care. But 'they do provide important insight into how two long-standing biologics in the treatment landscape compare to each other in patients with CRSwNP and coexisting asthma, which could support treatment decision-making for physicians,' he said. Tackling a Dual Burden CRSwNP is often marked by persistent nasal congestion, facial pain, and anosmia, and when asthma coexists, as it frequently does in this patient population, disease burden increases and managing symptoms becomes even more complex. Existing treatments have limited long-term benefit. Type 2 inflammation, driven largely by the interleukin-4 and interleukin-13 pathways, plays a central role in the pathophysiology of both CRSwNP and asthma. Dupilumab targets signalling of both molecules, whereas omalizumab primarily targets immunoglobulin E (IgE), a different antibody involved in allergic responses, and this mechanistic difference underpinned the rationale for the EVEREST trial. The EVEREST randomized, double-blind, active-controlled phase 4 trial enrolled 360 adults with severe, uncontrolled CRSwNP and coexisting asthma. Participants received either 300 mg of dupilumab subcutaneously every 2 weeks (n = 181) or omalizumab (n = 179) dosed based on body weight and baseline serum IgE levels every 2 or 4 weeks. All patients continued to receive mometasone furoate nasal spray as background therapy. Participants had a mean age 51.5 years, were 55% men, 42.5% had respiratory symptoms worsened by their use of nonsteroidal anti-inflammatory drugs, and roughly half had used systemic corticosteroids in the 2 years prior to the start of the study. Primary endpoints were nasal polyp score (range, 0-8) and University of Pennsylvania Smell Identification Test (range, 0-40). Greater improvement with dupilumab compared with omalizumab was evident by week 4 and continued through week 24, De Corso and his colleagues reported. At 24 weeks, dupilumab demonstrated statistically and clinically significant superiority over omalizumab in both primary endpoints with a 1.6-point greater reduction in nasal polyp score ( P < .001); and an eight-point greater improvement in smell identification ( P < .001). Secondary endpoints also favored dupilumab with a 0.58-point greater reduction in nasal congestion score; a 0.81-point greater improvement in loss of smell ( P < .001); a 1.74-point greater reduction in overall severity of symptoms; and a 12.7-point greater improvement in patient-reported quality of life ( P < .0001), the researchers reported. Use of dupilumab was also associated with small but statistically significant improvements in expiratory volumes and control of asthma, the study found. Safety profiles were similar between groups, with adverse events occurring in 64% of dupilumab recipients and 67% of omalizumab recipients, the researchers reported. Serious adverse events were reported in 2% of patients in the dupilumab arm and 4% in the omalizumab arm, and a slightly higher proportion of patients discontinued dupilumab due to adverse events (3% vs 1%), although no new safety concerns emerged in the analysis. 'These new results further reinforce those from the pivotal, regulatory phase 3 trials — SINUS-24 and SINUS-52 , where effects on nasal congestion and loss of smell were also observed as early as 4 weeks and showed continued improvement for the duration of the trial,' De Corso told Medscape Medical News . 'For patients living with both CRSwNP and asthma, the availability of a treatment that addresses both conditions effectively and quickly is a substantial advancement.' Michael S. Blaiss, MD, a clinical professor at the Medical College of Georgia at Augusta University, said, 'dupilumab showed statistically superior results on both primary endpoints — nasal polyp score, indicating polyp reduction, and UPSIT, measuring sense of smell improvement. These are key indicators of symptom relief and quality of life for my patients.' 'This type of head-to-head trial is exactly what clinicians have long called for to better guide treatment decisions in managing this complex condition,' he added. Javier Dominguez-Ortega MD, of the Department of Allergy at the Hospital Universitario La Paz, in Madrid, Spain, said EVEREST was 'indeed a highly innovative trial, particularly as it is the first head-to-head study examining two medications indicated for CRSwNP within a clinical trial setting. The preliminary data suggest that dupilumab demonstrates greater efficacy, especially in the area of olfaction, which has been objectively measured through olfactometry.' However, Dominguez-Ortega said that without clinical characteristics of the patients, including their inflammatory profiles prior to inclusion, or their concomitant treatments, drawing definitive conclusions was not possible. Better Sleep for Dermatitis Patients? In another study presented as an electronic poster at the meeting, researchers looked at the effects of dupilumab on sleep in adults with moderate-to-severe atopic dermatitis. The phase 4, double-blind trial, called DUPISTAD, randomly assigned adults to receive 300 mg of dupilumab or placebo every 2 weeks for 12 weeks, followed by a 12-week open-label extension. Actigraphy, using a wrist-wearable device, measured sleep disturbance objectively and non-invasively, while subjective measurement comprised patients' perceptions of sleep defined as the ratio of total sleep time to total time in bed. The mean difference from baseline to week 12 provided an estimate of weekly average sleep efficiency. In addition, actigraphy was studied in a subset of patients with poor sleep efficiency (≤ 70%) at baseline. A total of 127 patients received dupilumab and 60 received placebo. Patients reported significant sleep efficiency improvements with dupilumab based on sleep diaries but actigraphy did not generate consistent results. 'While patients reported significant sleep efficiency improvements following dupilumab treatment, actigraphy assessment was inconclusive,' the researchers reported. 'In this study, most patients had acceptable sleep efficiency at baseline, highlighting the limitations of wrist actigraphy to objectively assess sleep in patients with AD. The characteristics of AD may mean that these wrist-wearable devices are not appropriate to evaluate sleep.' Sensors mounted on walls and other nonwearable devices might better detect body movement at night and provide more accurate information about itching and sleep disturbance, they added. De Corso reported receiving funding from AstraZeneca, Firma, GlaxoSmithKline, Novartis, Regeneron, and serving on an advisory board and receiving fees from Sanofi. Blaiss has received speaking fees from Sanofi, Regeneron, and AstraZeneca, and consulting fees from Novartis and GlaxoSmithKline. Dominguez-Ortega has received consultation fees and compensation for participation in company sponsored speaker's events from AstraZeneca, CHIESI, Sanofi, Novartis, ALK, Leti Pharma, Cipla, Allergy Therapeutics GlaxoSmithKline, and Gebro. The EVEREST trial was funded by Sanofi, in collaboration with Regeneron Pharmaceuticals.
Associated Press
a day ago
- Associated Press
Libertas Bio, a Formation Bio subsidiary, License of Gusacitinib, a Dual JAK/SYK Inhibitor, to Sanofi
NEW YORK, June 23, 2025 /PRNewswire/ -- Formation Bio, an AI-native pharma company focused on accelerating drug development, today announced that its subsidiary Libertas Bio has licensed gusacitinib, an oral dual JAK/SYK inhibitor, to Sanofi. Sanofi will explore its potential in a new indication not previously studied through a phase 1 study. Gusacitinib was acquired by Formation Bio (formerly known as TrialSpark) in late 2022 from Asana BioSciences as part of a broader portfolio of investigational medicines. This transaction with Sanofi ushers gusacitinib into its next stage of development, with Sanofi leveraging its global expertise in drug development and commercialization to explore its potential in new indications. This transaction exemplifies Formation Bio's differentiated business model: identifying and acquiring high-potential clinical-stage assets. Formation Bio and Sanofi have several long-standing collaborations focused on identifying high-potential assets and co-developing AI tools that leverage shared data and technical expertise. This latest transaction builds on that collaboration, further strengthening both companies' commitment to advancing promising therapies through innovative technology and scientific excellence. Benjamine Liu, Co-Founder & CEO of Formation Bio, commented: 'Formation Bio is redefining drug development through radical efficiency at every step. We acquire high-potential assets, move quickly to unlock value, and partner at key inflection points. We're proud to have Sanofi as a world-class partner working together to accelerate innovation in medicine.' About Formation Bio Formation Bio is an AI-native pharma company differentiated by radically more efficient drug development. Formation Bio has built technology and AI platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies and biotechs to develop programs past clinical proof of concept and beyond, leveraging their proprietary tech and AI capabilities, ultimately helping to bring new medicines to patients. For more information, please visit Media Contact: [email protected] View original content to download multimedia: SOURCE Formation Bio
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