EASI

Almirall's Lebrikizumab Improves Signs and Symptoms of Moderate-to-Severe Atopic Dermatitis (AD) in Patients Inadequately Controlled With or Ineligible for Cyclosporine1

Retrieved on: 
Friday, October 13, 2023
Health, Managed Care, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Congress, EudraCT, Eli Lilly and Company, Knowledge, European Academies' Science Advisory Council, Advantage, CHMP, Abstract, Advocate, Ciclosporin, United Kingdom, BME, University, Week, Safety, ALM, Human, Disease, NRS, Psoriasis Area and Severity Index, Journal of the European Academy of Dermatology and Venereology, Almirall, Adolescence, Marketing, IGA, Adherence, AD, TCS, News, Overalls, EASI, Patient, Quality of life, Pharmaceutical industry, Dermatology, Venereology

Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared.

Key Points: 
  • Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.
  • Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe AD in additional European markets, including the United Kingdom and Switzerland in 2024.
  • † More information about the Phase 3 studies: ADvocate 1: EudraCT Number 2019-002932-10; NCT04146363; ADvocate 2: EudraCT Number 2019-002933-12; NCT04178967; ADhere: EudraCT Number 2019-004300-34; NCT04250337

Dermavant Announces New Positive Pruritus Data for VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as Two Years Old with Atopic Dermatitis at the EADV Congress 2023

Retrieved on: 
Thursday, October 12, 2023
Medical Supplies, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Congress, Journal of the European Academy of Dermatology and Venereology, Validation, Therapy, Caregiver, Atopic dermatitis, JD, Ageing, Addiction severity index, Itch, Patient, QD, EASI, Body surface area, Pharmaceutical industry, Dermatology, MD, Venereology

The new data presented at EADV 2023 contains daily recorded PP-NRS scores of patients in ADORING 1 and ADORING 2 on VTAMA cream for the first time.

Key Points: 
  • The new data presented at EADV 2023 contains daily recorded PP-NRS scores of patients in ADORING 1 and ADORING 2 on VTAMA cream for the first time.
  • Patients aged ≥12 years old self-completed the PP-NRS, while caregivers completed it for children aged
  • Improvements in daily PP-NRS scores with tapinarof versus vehicle continued through the first 2 weeks and through Week 8 of both trials.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Nektar Presents New Responder Data for Rezpegaldesleukin, a First-in-Class Selective Regulatory T-cell Therapy, in Late-Breaking News Oral Presentation at 2023 EADV Congress

Retrieved on: 
Friday, October 13, 2023
Congress, Senior, NKTR, Alopecia areata, European Academy of Management, George Washington University School of Engineering and Applied Science, Development, Journal of the European Academy of Dermatology and Venereology, DLQI, Atopic dermatitis, Outline of health sciences, Contact dermatitis, Nektar, Psoriasis Area and Severity Index, Pharmacodynamics, Maintenance, SAN, AD, EASI, BSA, Patient, NRS, Nektar Therapeutics, Body surface area, Pharmaceutical industry, Regulatory T cell, Dermatology, Venereology

SAN FRANCISCO, Oct. 13, 2023  /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today announced new data for rezpegaldesleukin (REZPEG), a first-in-class selective regulatory T-cell (Treg) therapy, in patients with atopic dermatitis (AD) at the 2023 European Academy of Dermatology and Venereology (EADV) Congress. These data were presented by Dr. Jonathan Silverberg, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Director of Clinical Research and Contact Dermatitis in a late-breaking oral presentation.

Key Points: 
  • "Data from this presentation demonstrate consistent benefit with REZPEG across multiple clinician and patient-reported outcomes, which were maintained through 36 weeks after treatment ended," said Dr. Jonathan Silverberg.
  • "The sustained post-treatment benefit observed with REZPEG has the potential to alter the need for frequent maintenance dosing for patients with atopic dermatitis.
  • Based on these data, the company is initiating two Phase 2 studies in atopic dermatitis and in alopecia areata.
  • Highlight of the new patient-reported outcomes for the Phase 1b study in atopic dermatitis presented at EADV 2023 for the first time:

Kyowa Kirin Announces Three Abstracts and A Symposium at the European Academy of Dermatology and Venereology Congress 2023

Retrieved on: 
Wednesday, October 11, 2023
Congress, Pain, Partnership, European Academies' Science Advisory Council, Amgen, AMG, Atopic dermatitis, Journal of the European Academy of Dermatology and Venereology, Inflammation, Kyowa Kirin, Week, TSE, Skin, Psoriasis Area and Severity Index, SCORAD, Itch, Neck, Score, Head, AD, Patient, Vaccine, Pharmaceutical industry, Dermatology, Venereology, EASI

Often beginning in childhood, AD affects 15-20% of children and up to 10% of adults, making it the 15th most common nonfatal disease.

Key Points: 
  • Often beginning in childhood, AD affects 15-20% of children and up to 10% of adults, making it the 15th most common nonfatal disease.
  • "We are pleased to share this additional data from the rocatinlimab Phase 2b study," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin.
  • "It provides further insight into the potential of rocatinlimab in treating patients living with moderate-to-severe atopic dermatitis.
  • EASI lichenification scores were assessed separately for the following body regions: head and neck (H&N), trunk, upper limbs, and lower limbs.

Aclaris Therapeutics Completes Enrollment in Phase 2b Study of ATI-1777 for Mild to Severe Atopic Dermatitis (ATI-1777-AD-202)

Retrieved on: 
Tuesday, October 3, 2023
Janus, Eczema Area and Severity Index, JAK, Clinical trial, Pharmacokinetics, Atopic dermatitis, ACRS, Patient, AD, Therapy, Safety, Rheumatoid arthritis, Pharmaceutical industry, EASI

WAYNE, Pa., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the completion of enrollment into ATI-1777-AD-202, its Phase 2b trial of its investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor, ATI-1777, in patients with mild to severe atopic dermatitis. Aclaris anticipates releasing top-line efficacy, safety and other preliminary data from this trial around the end of this year.

Key Points: 
  • Aclaris anticipates releasing top-line efficacy, safety and other preliminary data from this trial around the end of this year.
  • “We are very pleased to have completed the enrollment stage of our Phase 2b trial of ATI-1777 in atopic dermatitis, one of our two lead clinical development assets,” stated Gail Cawkwell, M.D., Ph.D., Aclaris’ Chief Medical Officer.
  • The Phase 2b trial follows the successful four-week Phase 2a trial in moderate to severe atopic dermatitis which demonstrated meaningful improvement in the modified Eczema Area and Severity Index (EASI) and minimal measurable systemic exposure with a 2% formulation applied twice daily.
  • The Phase 2b vehicle-controlled trial in atopic dermatitis further explores the concentration range (0.5%, 1% and 2%), as well as a once-daily regimen using the 2% formulation.

Nektar Therapeutics Announces Promising New Data from Phase 1b Study of Rezpegaldesleukin in Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Wednesday, September 13, 2023
Alopecia areata, Nektar, Nektar Therapeutics, Patient, Pharmacokinetics, DLQI, BSA, Therapy, Atopic dermatitis, NKTR, Week, EASI, Safety, Pharmaceutical industry, Regulatory T cell

SAN FRANCISCO, Sept. 13, 2023 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced new data for rezpegaldesleukin in patients with atopic dermatitis, including new clinical efficacy endpoints from the Phase 1b study. Rezpegaldesleukin is Nektar's novel, first-in-class selective regulatory T-cell (Treg) therapy, which is being developed for the treatment of atopic dermatitis.

Key Points: 
  • Rezpegaldesleukin is Nektar's novel, first-in-class selective regulatory T-cell (Treg) therapy, which is being developed for the treatment of atopic dermatitis.
  • The company is presenting the new Phase 1b clinical efficacy endpoints for rezpegaldesleukin at its investor and analyst event today.
  • The double-blind, randomized, placebo-controlled Phase 1b study of rezpegaldesleukin in atopic dermatitis evaluated safety, tolerability, and pharmacokinetics over a 12-week induction treatment period.
  • Highlights of final efficacy endpoints for the Phase 1b study in atopic dermatitis:

Alphyn Biologics Presents New Data from Phase 2a Trial Showing Significant Improvement of Mild-to-Moderate Atopic Dermatitis

Retrieved on: 
Monday, July 10, 2023
Infection, SIRS, Psoriasis Area and Severity Index, Body surface area, BSA, EASI, Hydrogel, MRSA, Atopic dermatitis, Staphylococcus aureus, Alphyn, Congress, IGA, Patient, Immune system, Poster, Bacteria, The Society, AD, Skin, Safety, Disease, Pharmaceutical industry, Birth control, Dermatology

ANNAPOLIS, Md., July 10, 2023 /PRNewswire/ -- Alphyn Biologics, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics®, today announced new data from the first cohort of its Phase 2a clinical trial program of AB-101a, a first-in-class topical candidate for treating atopic dermatitis (AD) in children ages 2 through adult. The data show significant skin clearance of the disease, itch reduction, and control of AD flares by treating the bacterial microbiome on the AD skin.

Key Points: 
  • The data show significant skin clearance of the disease, itch reduction, and control of AD flares by treating the bacterial microbiome on the AD skin.
  • The randomization resulted in an 81 percent mild AD enrollment, a study population that is difficult to show improvement resulting from therapeutic intervention.
  • As previously reported, the trial met all primary and secondary endpoints with minimal safety and side effects.
  • AB-101a is being studied in two cohorts of a Phase 2a trial program.

Alphyn Biologics Presents New Data from Phase 2a Trial Showing Significant Improvement of Mild-to-Moderate Atopic Dermatitis

Retrieved on: 
Monday, July 10, 2023
Infection, SIRS, Psoriasis Area and Severity Index, Body surface area, BSA, EASI, Hydrogel, MRSA, Atopic dermatitis, Staphylococcus aureus, Alphyn, Congress, IGA, Patient, Immune system, Poster, Bacteria, The Society, AD, Skin, Safety, Disease, Pharmaceutical industry, Birth control, Dermatology

ANNAPOLIS, Md., July 10, 2023 /PRNewswire/ -- Alphyn Biologics, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics®, today announced new data from the first cohort of its Phase 2a clinical trial program of AB-101a, a first-in-class topical candidate for treating atopic dermatitis (AD) in children ages 2 through adult. The data show significant skin clearance of the disease, itch reduction, and control of AD flares by treating the bacterial microbiome on the AD skin.

Key Points: 
  • The data show significant skin clearance of the disease, itch reduction, and control of AD flares by treating the bacterial microbiome on the AD skin.
  • The randomization resulted in an 81 percent mild AD enrollment, a study population that is difficult to show improvement resulting from therapeutic intervention.
  • As previously reported, the trial met all primary and secondary endpoints with minimal safety and side effects.
  • AB-101a is being studied in two cohorts of a Phase 2a trial program.

Connect Biopharma Presented Additional Data from its Atopic Dermatitis Pivotal Trial in China at the 2023 World Congress of Dermatology

Retrieved on: 
Monday, July 10, 2023
Maintenance, Connect, Psoriasis Area and Severity Index, BSA, Week, Atopic dermatitis, CNTB, Congress, IGA, DLQI, SCORAD, Patient, SAN, Entrepreneurship, Poster, AD, Safety, Pharmaceutical industry, Vaccine, Dietary supplement, Pros, EASI, Dermatology

“We were excited to share further data regarding rademikibart’s efficacy and safety, from what is the largest readout of an AD trial in China to date.” said Zheng Wei, Ph.D., Co-Founder and Chief Executive Officer of Connect Biopharma.

Key Points: 
  • “We were excited to share further data regarding rademikibart’s efficacy and safety, from what is the largest readout of an AD trial in China to date.” said Zheng Wei, Ph.D., Co-Founder and Chief Executive Officer of Connect Biopharma.
  • “Rademikibart not only yielded highly significant efficacy responses and was well tolerated, but the improvements seen were consistent across both investigator- and patient-reported outcomes as well.
  • Treatment with rademikibart led to rapid improvements in IGA 0/1, EASI, BSA and SCORAD, all without plateauing by Week 16.
  • The four poster presentations were available online on the World Congress of Dermatology site starting July 3rd, and in-person at the congress venue during the meeting.

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.