Journal of the European Academy of Dermatology and Venereology

Third Harmonic Bio Announces Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
Molecule, Research, KIT, IND, Journal of the European Academy of Dermatology and Venereology, G&A, Inflammation, MAD, Cold urticaria, R, Pharmacokinetics, European Academy of Management, Medicine, Venereology, Safety, D, SAN, Pharmaceutical industry, Cryptocurrency, Patient, Dermatology

SAN FRANCISCO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today announced financial results for the third quarter ended September 30, 2023.

Key Points: 
  • On October 31, 2023, Third Harmonic Bio announced the transition of Adrian S. Ray, Ph.D., from Chief Scientific Officer to Scientific Advisor effective November 1, 2023.
  • Additionally, the company announced that Robert Ho, Chief Financial Officer, is departing the organization on November 10, 2023.
  • R&D expenses for the nine months ended September 30, 2023 increased to $18.0 million, from $15.1 million for the same period in 2022.
  • G&A expenses for the nine months ended September 30, 2023 increased to $15.5 million, from $9.0 million for the same period in 2022.

MoonLake Immunotherapeutics announces the full dataset from its 24-week MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and differentiated therapeutic solution for Hidradenitis Suppurativa

Retrieved on: 
Sunday, October 15, 2023
III, PPT, Pain, Professor, Hidradenitis, Quality of life, European Academies' Science Advisory Council, Pharmacokinetics, Doctor of Philosophy, MS, Journal of the European Academy of Dermatology and Venereology, Education, DLQI, Data, Venereology, Safety, Psoriasis, Hidradenitis suppurativa, Moonlake, Disease, FDA, Adalimumab, Webcast, Immunology, Maintenance, Abscess, I&I, Master of Education, MIRA, PGI, Pennsylvania State University, Patient, HS, Pharmaceutical industry, Perfume, Birth control, Dermatology, MD, Inflammation

We have consistently observed best-in-class clinical activity with our Nanobody®sonelokimab for hidradenitis suppurativa and these results demonstrate its effect on a number of clinically meaningful endpoints.

Key Points: 
  • We have consistently observed best-in-class clinical activity with our Nanobody®sonelokimab for hidradenitis suppurativa and these results demonstrate its effect on a number of clinically meaningful endpoints.
  • In June we elevated the bar for clinical response to HiSCR75 as the primary endpoint.
  • The MIRA trial set a landmark milestone as the first placebo-controlled randomized trial in HS to use Hidradenitis Suppurative Clinical Response 75 (HiSCR75) as the primary endpoint.
  • The 24-week results show that ongoing treatment with sonelokimab 120mg and 240mg dosed Q4W, further increased HiSCR75 response rates compared to week 12.

Press Release: Late-breaking amlitelimab Phase 2b data presented at EADV show potential best-in-class profile in atopic dermatitis

Retrieved on: 
Friday, October 13, 2023
Congress, Conjunctivitis, Psoriasis Area and Severity Index, Atopic dermatitis, European Academy of Allergy and Clinical Immunology, Journal of the European Academy of Dermatology and Venereology, Patient, Disease, IGA, Vaccine, Dermatology, Venereology, EASI

The Phase 3 program for amlitelimab in atopic dermatitis is on track to start in the first half of 2024.

Key Points: 
  • The Phase 3 program for amlitelimab in atopic dermatitis is on track to start in the first half of 2024.
  • Global Head of Research & Development, Sanofi
    “The data presented at EADV provide more detailed insight into amlitelimab’s potential as a best-in-class therapy for people with atopic dermatitis.
  • TEAEs more commonly observed with amlitelimab compared to placebo included nasopharyngitis (11.0% amlitelimab, 9.0% placebo), COVID-19 (7.7% amlitelimab, 6.4% placebo) and headache (6.1% amlitelimab, 2.6% placebo).
  • Worsening of atopic dermatitis was more commonly observed with placebo compared to amlitelimab (38.5% placebo, 17.1% amlitelimab).

Encouraging Rigosertib Data Presented at EADV as Late Breaker

Retrieved on: 
Thursday, October 12, 2023
Professor, Cancer, Journal of the European Academy of Dermatology and Venereology, Late, RDEB, PMU, Carcinoma, Therapy, SCC, Concha bullosa, IST, Patient, Pharmaceutical industry, Dermatology, Venereology

“RDEB-associated SCC is a devastating disease with few if any treatment options for advanced patients.

Key Points: 
  • “RDEB-associated SCC is a devastating disease with few if any treatment options for advanced patients.
  • We are very pleased for additional data on the potential use of rigosertib in patients with RDEB-associated SCC to be presented as a ‘late breaker’ at EADV 2023,” said Steven Fruchtman, M.D., President and CEO of Onconova.
  • “We believe that rigosertib’s profile and impact on key cell signaling pathway targets, including PLK-1 kinase, could make rigosertib a very attractive approach for this indication and other cancers.
  • I am pleased to share the initial encouraging patient experience with rigosertib at this conference.

Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology

Retrieved on: 
Wednesday, October 11, 2023
Congress, Partnership, SB5, Physician, PASI, European Academies' Science Advisory Council, Pharmacokinetics, Ustekinumab, Abstract, Medicine, Novartis, PK, Week, European Commission, Safety, Psoriasis, Biosimilar, Adalimumab, Samsung, UST, EC, SB2, Journal of the European Academy of Dermatology and Venereology, Infliximab, United Kingdom membership of the European Economic Area, Biogen, Civil service commission, Etanercept, Patient, Generic drug, Medical device, Dermatology, Venereology, EEA

The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28.

Key Points: 
  • The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28.
  • SB17 is Samsung Bioepis’ fourth candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab).
  • Samsung Bioepis’ and Biogen’s anti-TNF treatment products have helped nearly 256,0003 patients in Europe.
  • Details of the Samsung Bioepis’ abstracts are as follows:

MoonLake Immunotherapeutics presents positive 12-week data from the Phase 2 MIRA trial with Nanobody® Sonelokimab for Hidradenitis Suppurativa at the European Academy of Dermatology and Venereology Congress

Retrieved on: 
Wednesday, October 11, 2023
PPT, Venereology, Journal of the European Academy of Dermatology and Venereology, Delta, Patient, HS, Copper, Dermatology

The primary analysis was based on the most stringent type of analysis for such trials, intent-to-treat non-responder imputation (“ITT-NRI”).

Key Points: 
  • The primary analysis was based on the most stringent type of analysis for such trials, intent-to-treat non-responder imputation (“ITT-NRI”).
  • As early as week 8, a significant difference in response between sonelokimab and placebo was observed across HiSCR thresholds, including HiSCR90.
  • In addition, other clinically relevant secondary endpoints also reached statistical significance at week 12 with sonelokimab compared with placebo.
  • Sonelokimab is currently being evaluated in a Phase 2 trial ( NCT05640245 ), ‘ARGO’, in patients with active psoriatic arthritis.

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

LEO Pharma Presents Phase 3 Results of Delgocitinib Cream for Adults with Moderate to Severe Chronic Hand Eczema (CHE) at EADV 2023

Retrieved on: 
Friday, October 13, 2023
Health, Science, Pharmaceutical, Research, Clinical Trials, Janus, Congress, Journal of the European Academy of Dermatology and Venereology, DELTA, JAK, Week, LEO, IGA, CHE, Patient, Pharmaceutical industry, Silviculture, Dermatology, Venereology

DELTA 2 is the second of two pivotal phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).1,4

Key Points: 
  • DELTA 2 is the second of two pivotal phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).1,4
    DELTA 2 was a randomized, double-blind, cream vehicle-controlled trial.
  • Adults were randomized to either twice-daily delgocitinib cream (n=314) or cream vehicle (n=159) for 16 weeks followed by a separate 36-week extension trial.
  • “Through assessment of the DELTA 1 and DELTA 2 trial results, we aim to assess the efficacy and safety of delgocitinib cream in adults living with this hard-to-treat disease."
  • “This latest collection of clinical data for delgocitinib cream supports LEO Pharma’s unwavering commitment to addressing the critical unmet need in CHE,” says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma.

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.

New Long-Term Data from Incyte Phase 3 TRuE-V Program Demonstrates Efficacy of Continued Treatment with Opzelura® (Ruxolitinib) Cream in Nonsegmental Vitiligo Patients

Retrieved on: 
Wednesday, October 11, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Congress, Journal of the European Academy of Dermatology and Venereology, Autoimmunity, Vitiligo, BID, Abstract, Ciclosporin, Inflammation, Depigmentation, Prevalence, Azathioprine, Pigmentation disorder, Melanocyte, American Academy, Week, University, JAK, AAD, Netherlands, Skin, LTE, Patient, Pharmaceutical industry, Dermatology, Venereology, Incyte

These long-term data highlight encouraging updates for an important sub-group of patients with nonsegmental vitiligo, those who initially showed limited or no response to treatment,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte.

Key Points: 
  • These long-term data highlight encouraging updates for an important sub-group of patients with nonsegmental vitiligo, those who initially showed limited or no response to treatment,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte.
  • Opzelura is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
  • The overall prevalence of the condition is estimated to be approximately 2-3 million2, with the majority of patients (approximately 85%) suffering from nonsegmental vitiligo3.
  • Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 304.