EASI

Press Release: Positive topline Phase 2b data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody

Retrieved on: 
Tuesday, June 27, 2023
NRS, Psoriasis Area and Severity Index, Asthma, Atopic dermatitis, Inflammation, IGA, Patient, Biomarker, United Kingdom, Safety, Disease, Surveying, Vaccine, Pharmaceutical industry, EASI

There were also improvements in key secondary outcome measures and continued improvements were observed through week 24 in primary and key secondary outcomes.

Key Points: 
  • There were also improvements in key secondary outcome measures and continued improvements were observed through week 24 in primary and key secondary outcomes.
  • “While we have made significant strides in the treatment of atopic dermatitis, there are patients who are still in need of new options.
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.
  • The study enrolled 390 people in Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, the United Kingdom and the United States.

Dermavant Reports Positive Topline Results from ADORING 1, the Second Atopic Dermatitis Phase 3 Trial of VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

Retrieved on: 
Tuesday, May 16, 2023
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Week, Surveying, EASI

“I am extremely proud to share the positive results from ADORING 1, the second of our two Phase 3 pivotal trials with VTAMA in adults and children as young as 2 years old with moderate to severe atopic dermatitis,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant.

Key Points: 
  • “I am extremely proud to share the positive results from ADORING 1, the second of our two Phase 3 pivotal trials with VTAMA in adults and children as young as 2 years old with moderate to severe atopic dermatitis,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant.
  • Importantly, VTAMA data indicated no new safety or tolerability signals in this population including children as young as 2 years old.
  • Dermavant recently released highly favorable results from a pediatric maximal usage pharmacokinetics (MUPK) study of VTAMA in AD.
  • On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of adult plaque psoriasis.

Roivant Reports Positive Topline Results from ADORING 1, the Second Atopic Dermatitis Phase 3 Trial of VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

Retrieved on: 
Tuesday, May 16, 2023
Week, Surveying, EASI

3Secondary Endpoint: Proportion of subjects ≥12 years old with a baseline PP-NRS score ≥4 who achieved ≥4-point reduction in the PP-NRS from baseline at Week 8.

Key Points: 
  • 3Secondary Endpoint: Proportion of subjects ≥12 years old with a baseline PP-NRS score ≥4 who achieved ≥4-point reduction in the PP-NRS from baseline at Week 8.
  • Importantly, VTAMA data indicated no new safety or tolerability signals in this population including children as young as 2 years old.
  • Adverse events of special interest included contact dermatitis (1.5% VTAMA vs. 2.2% vehicle) and follicular event (10.0% VTAMA vs. 0.7% vehicle).
  • Subjects were as young as 2 years old with up to 90% body surface area (BSA) affected with a mean BSA of 43%.

Evelo Biosciences Provides Clinical Updates

Retrieved on: 
Wednesday, April 26, 2023
Psoriasis Area and Severity Index, Psoriatic arthritis, EV, EASI, Atopic dermatitis, Psoriasis, EVS, Inflammatory bowel disease, Seminal vesicles, Patient, Axial spondyloarthritis, Webcast, Safety, Rheumatoid arthritis, Inflammation, Vaccine, Pharmaceutical industry

CAMBRIDGE, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis (SINTAX), today announced updates to its clinical programs.

Key Points: 
  • ET –
    CAMBRIDGE, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis (SINTAX), today announced updates to its clinical programs.
  • The primary endpoint was the proportion of patients who achieve an EASI-50 response at week 16,” said Simba Gill, Ph.D., CEO of Evelo.
  • “Given these results, we will cease further development of EDP1815 in atopic dermatitis, following a wind-down of the study.
  • Evelo will host a conference call and webcast at 8:30 a.m.

ASLAN Pharmaceuticals Announces Four Abstracts on Eblasakimab and Farudodstat, Including Two Late-Breakers, to be Presented at the 1st International Societies for Investigative Dermatology Meeting

Retrieved on: 
Monday, April 24, 2023
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Two further abstracts on eblasakimab, which were earlier accepted for presentation at the ISID meeting, have been published online in the Journal of Investigative Dermatology.

Key Points: 
  • Two further abstracts on eblasakimab, which were earlier accepted for presentation at the ISID meeting, have been published online in the Journal of Investigative Dermatology.
  • “The abstracts published today highlight the potential of eblasakimab to offer important differentiated benefits for AD patients.
  • Spontaneous neuronal activity was not impacted by IL-13 treatment but was increased with IL-4 treatment, which was also effectively reduced by eblasakimab.
  • This indicates that direct impact on neuronal responses may contribute to reduction of chronic itch demonstrated in AD patients treated with eblasakimab.

Minghui Pharmaceutical Inc. Announces Phase 2 Clinical Trial Success of MH004 Cream as a Potential Best-in-Class Topical Treatment for Mild-to-Moderate Atopic Dermatitis and the FDA Clearance of its Global Phase 3 MRCT

Retrieved on: 
Friday, April 14, 2023
Cream, Communication, Royal college, American Academy of Dermatology, BSA, College of Physicians and Surgeons of Ontario, JAK, Physician, Cancer, Pharmacokinetics, American Academy, Atopic dermatitis, Phase 2 (graffiti artist), Liu Minghui, Șaeș, Alopecia areata, Incidence, IGA, Royal College of Physicians and Surgeons of Canada, Surgeon, Prurigo nodularis, Vitiligo, AD, FDA, IND, Safety, Body surface area, Vaccine, Pharmaceutical industry, EASI

The study assessed safety, tolerability, pharmacokinetics (PK) and efficacy of two strengths of MH004 Cream.

Key Points: 
  • The study assessed safety, tolerability, pharmacokinetics (PK) and efficacy of two strengths of MH004 Cream.
  • "MH004 Cream is a topical cream containing a JAK inhibitor that was designed with Minghui's proprietary technology and formulation.
  • Based on the current phase 2 results, we plan to further pursue the development of MH004 Cream in atopic dermatitis as well as other dermatological diseases."
  • On April 1, the company received FDA IND approval for AD Phase 3 MRCTs after successful FDA communication and IND submission.

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
Science, Biotechnology, Research, Pharmaceutical, Health, Artificial Intelligence, Technology, Clinical Trials, NRS, Psoriasis Area and Severity Index, BSA, EASI, Tropomyosin receptor kinase B, Eczema Area and Severity Index, Body surface area, BAI, Tropomyosin receptor kinase C, Patient, Data, Euronext Amsterdam, Tropomyosin receptor kinase A, Ageing, AD, ITT, Skin, Safety, Disease, Pharmaceutical industry

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.”

LEO Pharma Presents Late-Breaking Positive Phase 2a Efficacy and Safety Results of LEO 138559 in Moderate-to-Severe Atopic Dermatitis at the 2023 AAD Annual Meeting

Retrieved on: 
Saturday, March 18, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Conditional sentence, University, Leo Pharma, BV, Aes, COVID-19, American Academy, Atopic dermatitis, Development, Dermatology, MD, Patient, AAD, LEO, American Academy of Dermatology, Cytokine, Upper respiratory tract infection, Safety, Pharmaceutical industry, EASI

LEO Pharma A/S, a global leader in medical dermatology, today announced that a Phase 2a trial evaluating the efficacy and safety of investigational agent LEO 138559 in adults with moderate-to-severe atopic dermatitis met its primary endpoint.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced that a Phase 2a trial evaluating the efficacy and safety of investigational agent LEO 138559 in adults with moderate-to-severe atopic dermatitis met its primary endpoint.
  • Results were shared as one of two LEO Pharma late breaker oral presentations at the 2023 American Academy of Dermatology (AAD) Annual Meeting.1 LEO 138559 is an investigational agent and its efficacy and safety are subject to further larger trials.
  • LEO Pharma and argenx BV jointly developed LEO 138559 under an exclusive option and research agreement.
  • LEO Pharma obtained the license to LEO 138559 in 2022 and now assumes the responsibility to develop and commercialize LEO 138559 for inflammatory skin disorders, such as atopic dermatitis.

Connect Biopharma CBP-201 Atopic Dermatitis China Pivotal Study Showed Rapid Relief of Patient Symptoms

Retrieved on: 
Saturday, March 18, 2023
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Maintenance, Psoriasis Area and Severity Index, EASI, Week, Dermatology, American Academy, Atopic dermatitis, IGA, 2008 Giro d'Italia, Stage 1 to Stage 11, Patient, Itch, AD, Skin, Inflammation, Vaccine

Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced that data from Stage 1 of the ongoing pivotal CBP-201 China trial in moderate-to-severe atopic dermatitis (AD) showed rapid relief from symptoms, as early as week one in some cases, and no efficacy plateau at Week 16.

Key Points: 
  • Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced that data from Stage 1 of the ongoing pivotal CBP-201 China trial in moderate-to-severe atopic dermatitis (AD) showed rapid relief from symptoms, as early as week one in some cases, and no efficacy plateau at Week 16.
  • In the study “CBP-201, a next-generation IL-4Rα antibody, achieved all primary and secondary efficacy endpoints in the treatment of adults with moderate-to-severe atopic dermatitis (AD): A randomized, double-blind, pivotal trial in China (CBP-201-CN002),” researchers reported on results from Stage 1 of the pivotal China trial of CBP-201 in moderate-to-severe AD.
  • Patients on active therapy experienced rapid relief of symptoms, with a reduction in itch at Week 1 and significant improvement in all study endpoints by Week 4, which was sustained to Week 16.
  • “We are honored to have data from our two CBP-201 atopic dermatitis studies at the prestigious American Academy of Dermatology Annual Meeting, showing rapid and sustained relief,” said Zheng Wei, Ph.D., Co-founder and CEO of Connect Biopharma.

Connect Biopharma CBP-201 Atopic Dermatitis Global Phase 2b Data Showed Rapid and Sustained Improvement Across all Body Regions

Retrieved on: 
Friday, March 17, 2023
Oncology, Health, Hospitals, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Week, EASI, Dermatology, Atopic dermatitis, American Academy, Head, Neck, Patient, AD, Inflammation, Vaccine

This is the first time CBP-201 AD improvements have been broken down by body regions and symptom subtypes.

Key Points: 
  • This is the first time CBP-201 AD improvements have been broken down by body regions and symptom subtypes.
  • In the abstract entitled “Rapid and Sustained Improvements with CBP-201 Across All Body Regions: Treatment of Atopic Dermatitis in a Phase 2b, Randomized, Double-blind, Placebo-controlled Trial (CBP-201-WW001),” researchers reported that CBP-201 demonstrated rapid improvement in AD as early as Week 2 and sustained at Week 16 across four body regions: head and neck, trunk, upper limbs and lower limbs, compared to placebo.
  • In addition to overall AD improvement across all four body regions, researchers also observed improvement for each classification of AD symptoms (signs): erythema, induration/papulation, lichenification and excoriation, within each body region.
  • “CBP 201 also showed good AD reductions in the head and neck region, which is often more difficult to treat.