Study Evaluated Adult Patients with Chronic Sinusitis with Nasal Polyposis who did not Respond to Intranasal Corticosteroids
BRIDGEWATER, NJ and TARRYTOWN, NY, USA I February 2, 2016 I Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. today announced that the Journal of the American Medical Association (JAMA) has published positive results from a Phase 2a study of dupilumab in adult patients with moderate-to-severe chronic sinusitis with nasal polyposis who did not respond to intranasal corticosteroids. Dupilumab is an investigational therapy that inhibits signaling of IL-4 and IL-13, two key cytokines required for the T helper 2 (Th2) immune response, which is believed to be a critical pathway in inflammation associated with chronic sinusitis with nasal polyps, asthma and atopic dermatitis. Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
“Despite current treatment options, including surgery to remove polyps, some patients with chronic sinusitis with nasal polyposis continue to experience difficult symptoms, including nasal congestion, decreased or lost sense of smell, and facial pain, which can negatively impact their quality of life. In addition, patients with this condition may experience sleep disturbances and decreased productivity,” said Claus Bachert, M.D., Ph.D., Professor and Head of Clinics, Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium and lead author of the JAMA paper. “This study, which also included patients with co-morbid asthma, supports previous observations that chronic sinusitis with nasal polyposis and asthma may share a core allergic inflammatory process driven by the IL-4 and IL-13 pathways.”
The topline results of this study were announced in September 2014. Please refer to today’s online publication for additional results from this study.
About the Phase 2 Study
The randomized, double-blind, placebo-controlled group study enrolled 60 adult patients with chronic sinusitis with nasal polyposis refractory to intranasal corticosteroids at 13 sites in the United States and Europe. Following four weeks of mometasone furoate nasal spray (MFNS) run-in, patients in the study received 300 milligrams (mg) of dupilumab or placebo once per week subcutaneously for 16 weeks, after an initial loading dose of 600 mg. All patients in the study continued to receive daily MFNS. Eligible patients had bilateral nasal polyposis and showed chronic symptoms of sinusitis, despite treatment with an intranasal corticosteroid for at least two months. Fifty-eight percent of patients in the study had received prior nasal surgery for their condition.
About Chronic Sinusitis with Nasal Polyposis
Chronic sinusitis with nasal polyposis causes mucosal inflammation and polyps in the nasal cavity and sinuses[i], which result in long-term symptoms of nasal obstruction and congestion, reduction in or loss of sense of smell, and facial pain.[ii] Nasal polyps can block normal drainage from the sinuses[iii] and negatively impacts quality of life.[iv] Patients with nasal obstruction or congestion have a two-fold higher risk of sleep dysfunction,[v] increased fatigue[vi], and decreased work productivity.[vii] About 75 percent of chronic sinusitis with nasal polyposis patients have a decreased sense of smell.[viii] The estimated prevalence of chronic sinusitis with nasal polyposis is up to 4 percent in the general population.[ix] Surgery may be considered in patients with chronic sinusitis with nasal polyposis who continue to experience nasal polyps and symptoms, despite medical treatment.ii
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases, and a rare inflammatory condition and have product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
[i] Upton, D. “Chronic Rhinosinusitis With Nasal Polyps: A Proteomic Analysis,” Annals of Otology, Rhinology & Laryngology 2011; 20(2):780-786.
[ii] Fokkens WJ, Lund VJ, Mullol J, et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012: a summary for otorhinolaryngologists. Rhinology. 2012;50(1):1-12. Medline:22469599
[iii] Steroids Followed by Topical Steroids. Annals of Internal Medicine 2011;154:293-30.
[iv] Banerji A, Piccirillo JF, Thawley SE, Levitt RG, Schechtman KB, Kramper MA, et al. Chronic rhinosinusitis patients with polyps or polypoid mucosa have a greater burden of illness. Am J Rhinol. 2007 Feb;21(1):19–26.
[v] Johnson, K. Nasal Polyps. WebMD. http://www.webmd.com/allergies/guide/nasal-polyps-symptoms-and-treatments?page=2 (Sept 5, 2012) Last Accessed: May 26, 2015.
[vi] Stull DE, Roberts L, Frank L, Heithoff K. Relationship of nasal congestion with sleep, mood, and productivity. Curr Med Res Opin. 2007 Apr;23(4):811-9.
[vii] Rudmik L, Smith TL, Schlosser RJ, Hwang PH, Mace JC, Soler ZM. Productivity Costs in Patients with Refractory Chronic Rhinosinusitis. Laryngoscope. 2014 Sep;124(9):2007–12.
[viii] Serrano, E. Nasal polyposis in France: impact on sleep and quality of life. The Journal of Laryngology & Otology. 2005 119: 543-549.
[ix] Akdis CA, Bachert C, Cingi C, Dykewicz et al. Endotypes and phenotypes of chronic rhinosinusitis: A PRACTALL document of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol 2013;131:1479-90.
SOURCE: Genzyme
Post Views: 109
Study Evaluated Adult Patients with Chronic Sinusitis with Nasal Polyposis who did not Respond to Intranasal Corticosteroids
BRIDGEWATER, NJ and TARRYTOWN, NY, USA I February 2, 2016 I Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. today announced that the Journal of the American Medical Association (JAMA) has published positive results from a Phase 2a study of dupilumab in adult patients with moderate-to-severe chronic sinusitis with nasal polyposis who did not respond to intranasal corticosteroids. Dupilumab is an investigational therapy that inhibits signaling of IL-4 and IL-13, two key cytokines required for the T helper 2 (Th2) immune response, which is believed to be a critical pathway in inflammation associated with chronic sinusitis with nasal polyps, asthma and atopic dermatitis. Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
“Despite current treatment options, including surgery to remove polyps, some patients with chronic sinusitis with nasal polyposis continue to experience difficult symptoms, including nasal congestion, decreased or lost sense of smell, and facial pain, which can negatively impact their quality of life. In addition, patients with this condition may experience sleep disturbances and decreased productivity,” said Claus Bachert, M.D., Ph.D., Professor and Head of Clinics, Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium and lead author of the JAMA paper. “This study, which also included patients with co-morbid asthma, supports previous observations that chronic sinusitis with nasal polyposis and asthma may share a core allergic inflammatory process driven by the IL-4 and IL-13 pathways.”
The topline results of this study were announced in September 2014. Please refer to today’s online publication for additional results from this study.
About the Phase 2 Study
The randomized, double-blind, placebo-controlled group study enrolled 60 adult patients with chronic sinusitis with nasal polyposis refractory to intranasal corticosteroids at 13 sites in the United States and Europe. Following four weeks of mometasone furoate nasal spray (MFNS) run-in, patients in the study received 300 milligrams (mg) of dupilumab or placebo once per week subcutaneously for 16 weeks, after an initial loading dose of 600 mg. All patients in the study continued to receive daily MFNS. Eligible patients had bilateral nasal polyposis and showed chronic symptoms of sinusitis, despite treatment with an intranasal corticosteroid for at least two months. Fifty-eight percent of patients in the study had received prior nasal surgery for their condition.
About Chronic Sinusitis with Nasal Polyposis
Chronic sinusitis with nasal polyposis causes mucosal inflammation and polyps in the nasal cavity and sinuses[i], which result in long-term symptoms of nasal obstruction and congestion, reduction in or loss of sense of smell, and facial pain.[ii] Nasal polyps can block normal drainage from the sinuses[iii] and negatively impacts quality of life.[iv] Patients with nasal obstruction or congestion have a two-fold higher risk of sleep dysfunction,[v] increased fatigue[vi], and decreased work productivity.[vii] About 75 percent of chronic sinusitis with nasal polyposis patients have a decreased sense of smell.[viii] The estimated prevalence of chronic sinusitis with nasal polyposis is up to 4 percent in the general population.[ix] Surgery may be considered in patients with chronic sinusitis with nasal polyposis who continue to experience nasal polyps and symptoms, despite medical treatment.ii
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases, and a rare inflammatory condition and have product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
[i] Upton, D. “Chronic Rhinosinusitis With Nasal Polyps: A Proteomic Analysis,” Annals of Otology, Rhinology & Laryngology 2011; 20(2):780-786.
[ii] Fokkens WJ, Lund VJ, Mullol J, et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012: a summary for otorhinolaryngologists. Rhinology. 2012;50(1):1-12. Medline:22469599
[iii] Steroids Followed by Topical Steroids. Annals of Internal Medicine 2011;154:293-30.
[iv] Banerji A, Piccirillo JF, Thawley SE, Levitt RG, Schechtman KB, Kramper MA, et al. Chronic rhinosinusitis patients with polyps or polypoid mucosa have a greater burden of illness. Am J Rhinol. 2007 Feb;21(1):19–26.
[v] Johnson, K. Nasal Polyps. WebMD. http://www.webmd.com/allergies/guide/nasal-polyps-symptoms-and-treatments?page=2 (Sept 5, 2012) Last Accessed: May 26, 2015.
[vi] Stull DE, Roberts L, Frank L, Heithoff K. Relationship of nasal congestion with sleep, mood, and productivity. Curr Med Res Opin. 2007 Apr;23(4):811-9.
[vii] Rudmik L, Smith TL, Schlosser RJ, Hwang PH, Mace JC, Soler ZM. Productivity Costs in Patients with Refractory Chronic Rhinosinusitis. Laryngoscope. 2014 Sep;124(9):2007–12.
[viii] Serrano, E. Nasal polyposis in France: impact on sleep and quality of life. The Journal of Laryngology & Otology. 2005 119: 543-549.
[ix] Akdis CA, Bachert C, Cingi C, Dykewicz et al. Endotypes and phenotypes of chronic rhinosinusitis: A PRACTALL document of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol 2013;131:1479-90.
SOURCE: Genzyme
Post Views: 109
