Eczema Area and Severity Index

LEO Pharma Presents New Long-Term Data on Use of Adtralza® (tralokinumab) to Treat Moderate-to-Severe Atopic Dermatitis (AD)

Retrieved on: 
Friday, October 13, 2023

LEO Pharma A/S, a global leader in medical dermatology, today presented new data assessing the long-term safety and efficacy data of continuous treatment with Adtralza® (tralokinumab) over four years for moderate-to-severe atopic dermatitis (AD) in adults.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today presented new data assessing the long-term safety and efficacy data of continuous treatment with Adtralza® (tralokinumab) over four years for moderate-to-severe atopic dermatitis (AD) in adults.
  • The analysis was of participants from ECZTEND who had previously enrolled in the ECZTRA 1 and 2 phase 3 trials.
  • Again, the pattern of adverse events (AEs) was consistent with the initial placebo-controlled treatment period and with no new safety signals identified.
  • “We aim to use this long-term and real-world evidence to build upon Adtralza’s existing foundation of research.”

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

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.

EBGLYSS® (lebrikizumab) Receives Positive CHMP Opinion for Moderate-to-severe Atopic Dermatitis

Retrieved on: 
Friday, September 15, 2023

The positive CHMP opinion is now being reviewed by the European Commission (EC).

Key Points: 
  • The positive CHMP opinion is now being reviewed by the European Commission (EC).
  • “Atopic dermatitis, commonly known as atopic eczema, can have a profound impact on the quality of life for those it affects.
  • "The positive CHMP recommendation for EBGLYSS in moderate to severe AD represents a significant milestone in bringing a next-generation biologic therapy to people living with atopic dermatitis, providing a much needed additional treatment option.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe.

Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.15% Showing Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Mild to Moderate Atopic Dermatitis (AD)

Retrieved on: 
Thursday, September 7, 2023

In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment up to 56 weeks in duration.

Key Points: 
  • In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment up to 56 weeks in duration.
  • Starting at Week 4 of INTEGUMENT-OLE, participants who achieved a vIGA-AD score of clear (0) switched to twice weekly maintenance dosing.
  • Participants were to resume once-daily dosing if vIGA-AD reached mild (2) or if signs or symptoms were not adequately controlled.
  • “Roflumilast cream is uniquely formulated to deliver treatment without sensitizing excipients and irritants, which can often disrupt the skin barrier.

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

Retrieved on: 
Thursday, July 6, 2023

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.

Aldeyra Therapeutics Enrolls First Patient in Phase 2 Clinical Trial of ADX-629 in Atopic Dermatitis

Retrieved on: 
Thursday, April 6, 2023

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced enrollment of the first patient in the Phase 2 clinical trial of orally administered RASP modulator ADX‑629, an investigational new drug, for the treatment of atopic dermatitis.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced enrollment of the first patient in the Phase 2 clinical trial of orally administered RASP modulator ADX‑629, an investigational new drug, for the treatment of atopic dermatitis.
  • The multicenter, adaptive, two-part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 alone and in combination with standard of care in adults with mild, moderate, or severe atopic dermatitis.
  • In addition to atopic dermatitis, ADX‑629 also is being evaluated in Phase 2 clinical trials for the treatment of chronic cough, idiopathic nephrotic syndrome, and Sjögren-Larsson Syndrome.
  • A Phase 2 clinical trial of ADX-629 in moderate alcohol-associated hepatitis is expected to initiate in the second half of 2023.

BenevolentAI Announces Top-Line Phase IIa Results for Its Topical pan-Trk Inhibitor BEN-2293 (1%) in Mild-to-Moderate Atopic Dermatitis

Retrieved on: 
Wednesday, April 5, 2023

BenevolentAI ("BenevolentAI" or the "Company") (Euronext Amsterdam: BAI) announces top-line results from its Phase IIa, randomised, double-blind, placebo-controlled study of BEN-2293, a topical pan-Trk inhibitor.

Key Points: 
  • BenevolentAI ("BenevolentAI" or the "Company") (Euronext Amsterdam: BAI) announces top-line results from its Phase IIa, randomised, double-blind, placebo-controlled study of BEN-2293, a topical pan-Trk inhibitor.
  • BEN-2293 is a selective inhibitor of the three tropomyosin-related kinases (Trk) receptors (TrkA, TrkB and TrkC) formulated to be administered topically in patients with mild-to-moderate AD.
  • Dr Anne Phelan, Chief Scientific Officer at BenevolentAI, said: "BEN-2293 was found to be safe and well tolerated in this study.
  • We will continue to review and analyse the complete dataset in order to fully understand the outcome and the next steps.”

Almirall announces EMA acceptance for filing of Marketing Authorization Application (MAA) for lebrikizumab in atopic dermatitis

Retrieved on: 
Friday, October 28, 2022

"Today marks the first step of the regulatory process in Europe of lebrikizumab, which we believe it has the potential to become a best-in-class treatment for atopic dermatitis.

Key Points: 
  • "Today marks the first step of the regulatory process in Europe of lebrikizumab, which we believe it has the potential to become a best-in-class treatment for atopic dermatitis.
  • Upon approvalby the EMA, patients with AD would have a new treatment option with a favourable safety and efficacy profile.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.
  • [*] More information about the Phase III studies: ADvocate 1: EudraCT Number 2019-002932-10; NCT04146363; ADvocate 2: EudraCT Number 2019-002933-12; NCT04178967; Adhere: EudraCT Number 2019-004300-34; NCT04250337

Evommune Initiates Phase 2a Proof-of-Concept Clinical Trial to Evaluate EVO101 in Atopic Dermatitis

Retrieved on: 
Wednesday, September 28, 2022

The Phase 2a trial is a randomized, double-blind, parallel group, vehicle-controlled study which will assess the safety, tolerability and preliminary efficacy of EVO101 topical cream, 0.1% BID, in 118 adults with mild to moderate AD in clinical sites across the United States.

Key Points: 
  • The Phase 2a trial is a randomized, double-blind, parallel group, vehicle-controlled study which will assess the safety, tolerability and preliminary efficacy of EVO101 topical cream, 0.1% BID, in 118 adults with mild to moderate AD in clinical sites across the United States.
  • The Phase 2a study follows the successful completion of a Phase 1 healthy volunteer study which evaluated 18 adult patients with EVO101 0.1% topical cream, applied twice daily to the ventral aspect of one forearm for seven days.
  • In the Phase 2a study, AD patients will apply EVO101 cream twice daily for eight weeks.
  • "From inception, we have remained focused on rapidly progressing multiple candidates into proof-of-concept clinical studies," said Luis Pea, President and Chief Executive Officer of Evommune.

LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Monday, September 19, 2022

There are limited treatment options for adolescents in the EU living with moderate-to-severe atopic dermatitis.

Key Points: 
  • There are limited treatment options for adolescents in the EU living with moderate-to-severe atopic dermatitis.
  • LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world.
  • Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial.
  • Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no.