BJD

Almirall’s First Quarter 2023 Results

Retrieved on: 
Monday, May 8, 2023
Biotechnology, Pharmaceutical, Health, The New England Journal of Medicine, Medical journal, Safety, Atopic dermatitis, JAMA Dermatology, BJD, Acquisition, Patient, MM, Ciclosporin, Ageing, Disease, Tildrakizumab, Science, American Academy of Dermatology, Face, Pharmacokinetics, Scalp, Advantage, EMA, Titan IIIB, BMJ, Growth, III, Psoriasis, Autoimmune disease, Accounting, Traction, Administration, AAD, Adolescence, American Academy, TRX, Almirall, Trial of the century, NEJM, Advocate, EBITDA, AD, Fine chemical, Medical imaging, Mobile phone, Pharmaceutical industry, Vaccine, EU, Dermatology

We delivered an excellent operational performance that sets us on track to meet our 2023 guidance.

Key Points: 
  • We delivered an excellent operational performance that sets us on track to meet our 2023 guidance.
  • We remain focused on preparing the business for the expected approval of lebrikizumab in late 2023, a product with the potential to transform our company.
  • Almirall is confident that its European business will continue to flourish throughout 2023 with the contribution of new countries where Ilumetri® has been recently launched.
  • In the first quarter of 2023, Almirall announced several positive clinical updates on lebrikizumab.

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.

Almirall: The New England Journal of Medicine (NEJM) and the British Journal of Dermatology (BJD) Publish Ph3 Data Evaluating lebrikizumab Efficacy and Safety in Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Friday, March 31, 2023
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Inflammation, The New England Journal of Medicine, University, Week, George Washington University School of Medicine & Health Sciences, Sleep, Quality of life, Atopic dermatitis, Multimedia, NEJM, TCS, BJD, Advocate, ALM, Publication, IGA, Patient, Outline of health sciences, Adolescence, Eli Lilly and Company, AD, Safety, Skin, Pharmaceutical industry, Dermatology, Almirall, Medicine

ADvocate1 and ADvocate2 are two identical 52-week randomized, double-blind, placebo-controlled, parallel-group, Phase 3 studies (NCT04146363 and NCT04178967), evaluating lebrikizumab as monotherapy in adult and adolescent* patients with moderate-to-severe atopic dermatitis.

Key Points: 
  • ADvocate1 and ADvocate2 are two identical 52-week randomized, double-blind, placebo-controlled, parallel-group, Phase 3 studies (NCT04146363 and NCT04178967), evaluating lebrikizumab as monotherapy in adult and adolescent* patients with moderate-to-severe atopic dermatitis.
  • “In clinical trials, patients experienced significantly clearer skin and less interference with sleep due to itch when taking lebrikizumab compared to placebo.
  • “We are delighted by the publication of the Phase 3 data in the NEJM and BJD respectively, highly regarded and rigorously peer-reviewed journals.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.

MoonLake Immunotherapeutics announces the publication of new long-term disease control data from a Phase 2b Psoriasis trial of the Nanobody® sonelokimab

Retrieved on: 
Monday, May 9, 2022
Antibody, Severity, VHH, 40, Forward-looking statement, Veni, vidi, vici, Maintenance, DLQI, Company, BJD, Physician, Safety, Secukinumab, Chemokine, KDA, Patient, Hidradenitis suppurativa, Pain scale, Temperature, Moonlake, Clinical trial, Data analysis, Psoriatic arthritis, Inflammation, Adalimumab, Numerical, MIRA, Data, Skin, Adult, Private Securities Litigation Reform Act, Plaque, Dermatology Life Quality Index, Ankylosing spondylitis, Comparable, HS, Abscess, Pharmaceutical industry, Vaccine, Sanofi, Ablynx

MoonLake Immunotherapeutics AG is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory disease, to revolutionize outcomes for patients.

Key Points: 
  • MoonLake Immunotherapeutics AG is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory disease, to revolutionize outcomes for patients.
  • Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody consisting of three VHH domains covalently linked by flexible glycine-serine spacers.
  • Sonelokimab has been assessed in a randomized, placebo-controlled Phase 2b trial in 313 patients with moderate-to-severe plaque-type psoriasis.
  • The trial will comprise over 200 patients, and will evaluate two different doses of sonelokimab, with placebo control and adalimumab as an active control reference arm.