Psoriasis Area and Severity Index

EMA Accepts MAA for DMB-3115 of Dong-A ST, a Stelara Biosimilar

Retrieved on: 
Monday, July 17, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Psoriasis Area and Severity Index, Intas Pharmaceuticals, Psoriatic arthritis, Partnership, CET, Ustekinumab, CSO, IQVIA, Dong Jiahong, Meiji, Marketing, Ulcerative colitis, Psoriasis, EMA, European Medicines Agency, Patient, PASI, Marketing Authorisation Application, MAA, Donga, III, MMA, Pharmaceutical industry, EU, Accord

Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab).

Key Points: 
  • Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab).
  • Accord , a wholly owned subsidiary of Intas Pharmaceuticals Ltd, submitted the MAA to EMA on June 23rd, and the EMA accepted the MMA submission on July 14th in CET.
  • The MAA submission is based on the results of an extensive analytical similarity assessment of DMB-3115 with that US and EU-sourced STELARA using current ‘state-of-the-art’ methods.
  • The MAA submission also comprised the results from the phase III multi-regional clinical trials in patients with plaque psoriasis (NCT04785326).

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.

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.

Ventyx Biosciences Announces Completion of Enrollment of the Phase 2 Trial of VTX002 in Ulcerative Colitis and the Phase 2 Trial of VTX958 in Plaque Psoriasis

Retrieved on: 
Wednesday, June 7, 2023
Psoriasis Area and Severity Index, Week, Ulcerative colitis, Psoriasis, Patient, TYK2, PASI, Inflammation, Pharmaceutical industry

“I am very proud of our team’s execution as we mark another important milestone for Ventyx and for ulcerative colitis and plaque psoriasis patients,” said Dr. William Sandborn, President and Chief Medical Officer.

Key Points: 
  • “I am very proud of our team’s execution as we mark another important milestone for Ventyx and for ulcerative colitis and plaque psoriasis patients,” said Dr. William Sandborn, President and Chief Medical Officer.
  • “We believe the robust enrollment activity in these trials demonstrates tremendous interest from patients and investigators in novel oral therapies for autoimmune diseases.
  • The primary efficacy endpoint is the proportion of subjects achieving clinical remission at Week 13 as defined by the modified Mayo Score.
  • The Phase 2 SERENITY trial of VTX958, an oral, selective, allosteric TYK2 inhibitor, is a randomized, double-blind, placebo-controlled, dose-ranging trial in patients with moderate to severe plaque psoriasis.

DICE Therapeutics Reports First Quarter 2023 Financial Results and Recent Highlights

Retrieved on: 
Thursday, May 11, 2023
DICE, Psoriasis Area and Severity Index, D, Clinical trial, American Academy, Psoriasis, Patient, AAD, American Academy of Dermatology, Conditional sentence, R, Research, Therapy, Pharmaceutical industry

The first psoriasis patient has been dosed in our global, dose-ranging Phase 2b clinical trial of DC-806,” said Kevin Judice, Ph.D., CEO of DICE.

Key Points: 
  • The first psoriasis patient has been dosed in our global, dose-ranging Phase 2b clinical trial of DC-806,” said Kevin Judice, Ph.D., CEO of DICE.
  • “We also look forward to topline data in healthy volunteers from our Phase 1 trial with our second oral IL-17 inhibitor, DC-853, expected in the second half of 2023.
  • R&D Expenses: Research and development expenses were $23.7 million for the first quarter of 2023, compared to $13.4 million for the same period in 2022.
  • G&A Expenses: General and administrative expenses were $7.9 million for the first quarter of 2023, compared to $5.4 million for the same period in 2022.

Aldeyra Therapeutics Reports First-Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, May 4, 2023
Biotechnology, Pharmaceutical, Optical, Health, RASP, Psoriasis Area and Severity Index, Adaptation, Retinitis pigmentosa, Quality of life, Atopic dermatitis, Methotrexate, Pollen, Part, Inflammation, Chronic cough, Clinical trial, Patient, Standard of care, Enrollment, Malondialdehyde, Allergy, PDUFA, Electroretinography, Allergic conjunctivitis, Therapy, Visual acuity, Safety, Pharmaceutical industry, Medical imaging

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended March 31, 2023.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended March 31, 2023.
  • Top-line results from the Phase 2 clinical trial are expected in the second quarter of 2023.
  • Beginning with this announcement of first quarter 2023 financial results, Aldeyra will no longer conduct quarterly conference calls to discuss financial results.
  • Aldeyra plans to continue hosting conference calls, as appropriate, to report the results of certain clinical trials and other material information concerning regulatory and clinical developments.

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.