Dupilumab

Eblasakimab Monthly Dosing Shows Potential for Best-In-Class Therapy in Positive Phase 2b Study in Atopic Dermatitis

Retrieved on: 
Thursday, July 6, 2023
Lead, Psoriasis Area and Severity Index, US Foods, Arm, ASLN, Aes, Atopic dermatitis, Eczema Area and Severity Index, Inflammation, Oregon Health and Science University Center for Women's Health, Type 2, Patient, SAN, Common, Trial, TREK, Upper respiratory tract infection, Headache, ITT, Conjunctivitis, Allergic inflammation, Food, Disease, Vaccine, Medical imaging, Pharmaceutical industry, Hydraulic machinery, Fertilizer, EASI, Dupilumab

Regimens dosing once every two weeks also met the primary endpoint with statistical significance, as well as meeting key secondary endpoints.

Key Points: 
  • Regimens dosing once every two weeks also met the primary endpoint with statistical significance, as well as meeting key secondary endpoints.
  • Eblasakimab was generally well-tolerated at all dose levels, with low rates of conjunctivitis and injection site reactions supporting the potential for a differentiated safety profile.
  • SAN MATEO, Calif. and SINGAPORE, July 06, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced positive topline data from its Phase 2b dose-ranging study of eblasakimab in adult patients with moderate-to-severe atopic dermatitis (AD), the TREK-AD (TRials with EblasaKimab in Atopic Dermatitis) study.
  • The Company is also conducting the TREK-DX (TRials in EblasaKimab in Dupilumab eXperienced AD patients) study of eblasakimab in dupilumab-experienced patients and expects to announce topline data from that study in 1Q 2024.

Dupixent® (dupilumab) Late-breaking Phase 3 COPD Results Presented at ATS and Simultaneously Published in the New England Journal of Medicine

Retrieved on: 
Sunday, May 21, 2023
COPD, The New England Journal of Medicine, Depression, Smoking, University, Hospital, Anxiety, ATS, JAMA, Quality of life, Risk, Associate, Cough, NEJM, Sleep, Chronic obstructive pulmonary disease, Periodic breathing, Regeneron Pharmaceuticals, Clinical trial, American Thoracic Society, International Conference on Population and Development, Patient, Health, Death, Conference, News, Disease, Critical Care Medicine (journal), Pharmaceutical industry, Medicine, Dupilumab, Sanofi

TARRYTOWN, N.Y. and PARIS, May 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented positive Phase 3 results evaluating the investigational use of Dupixent® (dupilumab) compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation. The Dupixent Phase 3 results were presented in the 2023 American Thoracic Society (ATS) International Conference session “New England Journal of Medicine and JAMA. Discussion on the Edge: Reports of Recently Published Pulmonary Research” and simultaneously published in the New England Journal of Medicine (NEJM). These results will also be presented in the “Breaking News: Clinical Trial Results in Pulmonary Medicine” session on May 22.

Key Points: 
  • The Dupixent Phase 3 results were presented in the 2023 American Thoracic Society (ATS) International Conference session “New England Journal of Medicine and JAMA.
  • Discussion on the Edge: Reports of Recently Published Pulmonary Research” and simultaneously published in the New England Journal of Medicine (NEJM).
  • These results will also be presented in the “Breaking News: Clinical Trial Results in Pulmonary Medicine” session on May 22.
  • The results presented at ATS and published in NEJM are from the BOREAS trial, which met the primary and all key secondary endpoints.

Press Release: Dupixent® (dupilumab) late-breaking Phase 3 COPD results presented at ATS and simultaneously published in the New England Journal of Medicine

Retrieved on: 
Sunday, May 21, 2023
COPD, The New England Journal of Medicine, Depression, Smoking, University, Hospital, Associate professor, Critical Care Medicine (journal), Anxiety, ATS, JAMA, Quality of life, Risk, Cough, NEJM, Sleep, Chronic obstructive pulmonary disease, Periodic breathing, Clinical trial, American Thoracic Society, International Conference on Population and Development, Patient, Health, Death, Conference, News, Disease, Pharmaceutical industry, Dupilumab, Medicine

Discussion on the Edge: Reports of Recently Published Pulmonary Research” and simultaneously published in the New England Journal of Medicine (NEJM).

Key Points: 
  • Discussion on the Edge: Reports of Recently Published Pulmonary Research” and simultaneously published in the New England Journal of Medicine (NEJM).
  • These results will also be presented in the “Breaking News: Clinical Trial Results in Pulmonary Medicine” session on May 22.
  • The results presented at ATS and published in NEJM are from the BOREAS trial, which met the primary and all key secondary endpoints.
  • The safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority.

Almirall: Up to 73% of Atopic Dermatitis Patients Taking Lebrikizumab Had Improved or Cleared Skin on Face or Hands in New Analysis

Retrieved on: 
Monday, May 1, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, The New England Journal of Medicine, AE, RAD, Face, Safety, Aes, Adherence, Atopic dermatitis, Dupilumab, Almirall, NEJM, Sample size determination, JAMA Dermatology, BJD, LEB, Advocate, Lilly, Patient, Common, Adolescence, Headache, Conjunctivitis, Abstract, Fertilizer, Pharmaceutical industry, Dermatology

This post-hoc analysis is based on individual patient trajectory data from two double-blind, placebo-controlled, monotherapy Phase 3 studies of lebrikizumab in adult and adolescent patients with moderate-to-severe AD.

Key Points: 
  • This post-hoc analysis is based on individual patient trajectory data from two double-blind, placebo-controlled, monotherapy Phase 3 studies of lebrikizumab in adult and adolescent patients with moderate-to-severe AD.
  • Safety among patients in ADvocate 1 and ADvocate 2 at one year was consistent with the induction phase of the trials and other lebrikizumab studies in AD, including ADhere.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.
  • Lilly has exclusive rights for development and commercialization of lebrikizumab in the U.S. and the rest of the world outside Europe.

Up to 73% of Atopic Dermatitis Patients Taking Lilly's Lebrikizumab Had Improved or Cleared Skin on Face or Hands in New Analysis

Retrieved on: 
Monday, May 1, 2023
The New England Journal of Medicine, AE, RAD, Face, Safety, Aes, Adherence, Atopic dermatitis, Medicine, Dupilumab, Almirall, NEJM, Sample size determination, JAMA Dermatology, BJD, LEB, Advocate, Lilly, Patient, Common, Adolescence, Headache, Conjunctivitis, Abstract, Disease, Fertilizer, Pharmaceutical industry, Dermatology

This post-hoc analysis is based on individual patient trajectory data from two double-blind, placebo-controlled, monotherapy Phase 3 studies of lebrikizumab in adult and adolescent patients with moderate-to-severe AD.

Key Points: 
  • This post-hoc analysis is based on individual patient trajectory data from two double-blind, placebo-controlled, monotherapy Phase 3 studies of lebrikizumab in adult and adolescent patients with moderate-to-severe AD.
  • Safety among patients in ADvocate 1 and ADvocate 2 at one year was consistent with the induction phase of the trials and other lebrikizumab studies in AD, including ADhere.
  • Most AEs across the two studies were mild or moderate in severity, nonserious, and did not lead to treatment discontinuation.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.

SAB Biotherapeutics Provides Company Update for Full Year 2022

Retrieved on: 
Friday, March 31, 2023
Clostridioides difficile infection, SAB, Teva Pharmaceuticals, GLP, RADM, Insurance, Emergent BioSolutions, Omicron, Drug development, SARS-CoV-2, Bank statement, COVID-19, Biologic, Health, NDA, Form 10-K, Emergent, CSL, Immunotherapy, Antibody, Government, CDC, Surgeon General of the United States, Plasma, US, Patient, Annual report, DSM-IV codes, Immunoglobulin G, AMI, Viral load, Privacy and the US government, Entrepreneurship, Security (finance), Blaine Higgs, Immunodeficiency, Therapy, IND, Rear admiral, Conference, Infection, U.S. Public Health Service reorganizations of 1966–1973, Vaccine, Pharmaceutical industry, Cryptocurrency, Clostridioides, Dupilumab

SIOUX FALLS, S.D., March 31, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulin (hIgG) antibodies, also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the full year ended December 31, 2022, and provided a company update.

Key Points: 
  • SIOUX FALLS, S.D., March 31, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulin (hIgG) antibodies, also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the full year ended December 31, 2022, and provided a company update.
  • C. diff is a devastating disease recognized by the CDC as an urgent antibiotic resistance threat,” said Eddie J. Sullivan, Ph.D., Co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics.
  • Cash Position: Cash and cash equivalents were $15.0 million as of December 31, 2022, compared to $33.2 million on December 31, 2021.
  • The Company will restate its prior period financial results in its Annual Report on Form 10-K for the fiscal year ended December 31, 2022.

Sanofi/Regeneron's Dupixent Performance in Eosinophilic Esophagitis is Paving the Way for Future Therapies in an Underserved and Growing Market, According to Spherix Global Insights

Retrieved on: 
Tuesday, April 4, 2023
Asthma, Eosinophilic esophagitis, Takeda, Symantec Endpoint Protection, IBD, Gastroenterology, Atopic dermatitis, Polyp (medicine), Launch, AstraZeneca, Alexander Kapp (dermatologist and allergist), Eosinophil, Steroid, Prurigo, Inflammatory bowel disease, Patient, Physician, Risk, EOE, Sinusitis, Growth, BMS, FDA, AD, Disease, Pharmaceutical industry, Dupilumab

EXTON, Pa., April 3, 2023 /PRNewswire/ -- In 2017, Sanofi/Regeneron announced the FDA approval for the first biologic agent to treat atopic dermatitis (AD). The success of that drug, Dupixent (dupilumab), inspired competitors to scramble for a place in the AD market, with the second drug arriving nearly five years later. Sanofi/Regeneron followed with indications in asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis (EoE) and most recently prurigo nodularis.

Key Points: 
  • Sanofi/Regeneron followed with indications in asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis (EoE) and most recently prurigo nodularis.
  • The May 2022 approval of Dupixent for EoE opened the door to another untapped market, with the closest competitor entry likely several years away.
  • Spherix will continue to track the performance of Dupixent's launch for the first eighteen months on the market.
  • Performance to date suggests Dupixent will continue to carve out a commanding ownership of the advanced treatment market in EoE, while also paving the way for future competitors to meet the needs of this underserved, growing market.

Dupixent® (dupilumab) Demonstrates Potential to Become First Biologic to Treat COPD by Showing Significant Reduction in Exacerbations in Pivotal Trial

Retrieved on: 
Thursday, March 23, 2023
COPD, Smoker, Depression, Smoking, Hospital, Regeneron Pharmaceuticals, Anxiety, Quality of life, Inflammation, Cough, Sleep, Chronic obstructive pulmonary disease, Periodic breathing, Patient, Biology, Health, Death, Caregiver, Disease, Pharmaceutical industry, Medical device, Dupilumab, Sanofi

“In this landmark Phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic.

Key Points: 
  • “In this landmark Phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic.
  • COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization or even death.
  • Patients receiving Dupixent experienced:
    30% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0005), the primary endpoint.
  • The safety and efficacy of Dupixent and itepekimab in COPD have not been fully evaluated by any regulatory authority.

Press Release: Dupixent® demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial 

Retrieved on: 
Thursday, March 23, 2023
COPD, Smoker, Depression, Smoking, Hospital, Anxiety, Quality of life, Inflammation, Cough, Sleep, Chronic obstructive pulmonary disease, Periodic breathing, Patient, Biology, Health, Death, Caregiver, Disease, Pharmaceutical industry, Dupilumab

We took a bold approach with our direct to Phase 3 program, shaving years off standard clinical development timelines.

Key Points: 
  • We took a bold approach with our direct to Phase 3 program, shaving years off standard clinical development timelines.
  • Smoking is a key risk factor for COPD, but even individuals who quit smoking can still develop the disease.
  • Patients receiving Dupixent experienced:
    30% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0005), the primary endpoint.
  • The safety and efficacy of Dupixent and itepekimab in COPD have not been fully evaluated by any regulatory authority.

Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis

Retrieved on: 
Tuesday, March 21, 2023
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TARRYTOWN, N.Y. and PARIS, March 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. With this approval, Dupixent is the first and only targeted medicine indicated to treat these young children in Europe and the U.S.

Key Points: 
  • “I’ve personally witnessed how this chronic skin disease can disrupt the lives of entire families when left uncontrolled.
  • Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood.
  • Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers.
  • “Too often the parents and caregivers of children with severe atopic dermatitis are left desperate for new treatments to manage this chronic disease.