Psoriasis Area and Severity Index

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.

Takeda Announces Positive Results in Phase 2b Study of Investigational TAK-279, an Oral, Once-Daily TYK2 Inhibitor, in People with Moderate-to-Severe Plaque Psoriasis

Retrieved on: 
Saturday, March 18, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, TAK, Psoriasis, PASI, University, Skin, Psoriasis Area and Severity Index, American Academy of Dermatology, American Academy, MPH, Patient, AAD, TYK2, Dean (education), Pharmaceutical industry, Dermatology, Takeda

Takeda ( TSE:4502/NYSE:TAK ) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis.
  • Changes in laboratory parameters were consistent with known effects of allosteric TYK2 inhibition.1
    “These compelling TAK-279 data strengthen its potential for people with moderate-to-severe plaque psoriasis.
  • Results from the Phase 2b study have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2023 (Fiscal Year 2022).
  • *In the TAK-279 2mg arm, the PASI 90 response rate was 8% with a nominal p-value = 0.037 compared to placebo.1

UCB to Present Eight Bimekizumab Abstracts at AAD 2023 with Results from Studies in Psoriasis, Psoriatic Arthritis, and Hidradenitis Suppurativa

Retrieved on: 
Thursday, March 16, 2023
Abstract, Psoriatic arthritis, Bimekizumab, Secukinumab, Psoriasis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Skin, BE, Maintenance, AAD, UCB, American Academy, Patient, Conditional sentence, Psoriasis Area and Severity Index, Welsh Terrier, HS, Hidradenitis suppurativa, Week, Safety, Food, American Academy of Dermatology, Phase 3, Pharmaceutical industry, Medical imaging

The abstracts have been accepted as one late-breaking oral platform presentation and seven posters, including three with oral presentations.

Key Points: 
  • The abstracts have been accepted as one late-breaking oral platform presentation and seven posters, including three with oral presentations.
  • Five of the eight abstracts at AAD 2023 will share data on bimekizumab in the treatment of moderate to severe plaque psoriasis, including data evaluating bimekizumab in the treatment of nail psoriasis from the BE RADIANT Phase 3b trial.
  • Bimekizumab versus secukinumab for the treatment of nail psoriasis in patients with moderate to severe plaque psoriasis: Results from the BE RADIANT phase 3b trial.
  • Bimekizumab improved efficacy measures in patients with active psoriatic arthritis and moderate or severe psoriasis: Pooled 16-week results from phase 3 randomized, placebo-controlled studies BE OPTIMAL and BE COMPLETE.

Dermavant to Present Data from Multiple Studies of VTAMA® (tapinarof) cream, 1% at the 2023 American Academy of Dermatology Annual Meeting

Retrieved on: 
Friday, March 10, 2023
Biotechnology, Pharmaceutical, Health, Cream, Journal, Psoriasis Area and Severity Index, QD, Psoriasis, Nose, Pain, Itch, Body surface area, Oral, Abstract, Headache, Rash, Folliculitis, Pivotal, American Academy, PGA, Pharmacokinetics, Therapy, Irritation, Prescription, Stinger, Food, Composite, Incidence, PASI, Common, BSA, FDA, Convention, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, JAAD, Swelling, Pharmaceutical industry, Dietary supplement, Cosmetics, Medical imaging, Dermatology

Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that data from multiple studies of VTAMA®(tapinarof) cream, 1% will be presented at the 2023 American Academy of Dermatology Annual Meeting, to be held from March 17-21 in New Orleans, Louisiana.

Key Points: 
  • Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that data from multiple studies of VTAMA®(tapinarof) cream, 1% will be presented at the 2023 American Academy of Dermatology Annual Meeting, to be held from March 17-21 in New Orleans, Louisiana.
  • This fall, all of the abstracts will also be published in the Journal of the American Academy of Dermatology (JAAD).
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.
  • Visit fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Dermavant Sciences at 1-8 DERMAVANT (1-833-762-8268).

Aldeyra Therapeutics Advances Investigational Oral RASP Modulator ADX‑629 Into New Phase 2 Systemic Disease Trials

Retrieved on: 
Thursday, February 16, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Edema, Pharmacology, Syndrome, Safety, RASP, Metabolism, Proteinuria, Patient, Asthma, Clinical trial, Atopic dermatitis, Skin, Therapy, Plasma, Psoriasis Area and Severity Index, Part, Nephrotic syndrome, COVID-19, Quality of life, Psoriasis, Pharmaceutical industry, Hypoalbuminemia

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome.
  • Additionally, Aldeyra announced the initiation of a Phase 2 clinical trial of ADX‑629 in atopic dermatitis.
  • Moderate Alcohol-Associated Hepatitis: Aldeyra plans to support an investigator-sponsored Phase 2 clinical trial of ADX‑629 in moderate alcohol-associated hepatitis.
  • In a Phase 2 clinical trial announced last year, ADX-629 reduced dermal flushing and improved balance time following alcohol intoxication.

Nimbus Therapeutics Announces Closing of Takeda’s Acquisition of TYK2 Subsidiary

Retrieved on: 
Wednesday, February 8, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, MBA, TYK2, Therapy, HPK1, Acquisition, Patient, Computational chemistry, Psoriasis Area and Severity Index, TAK, DSM-IV codes, Psoriasis, Cancer, Pharmaceutical industry, Nimbus, Takeda

Nimbus Therapeutics , LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the closing of Takeda’s (TSE:4502/NYSE:TAK) acquisition of Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus, and its tyrosine kinase 2 (TYK2) inhibitor program, which includes the oral, selective allosteric TYK2 inhibitor NDI-034858, now known as TAK-279.

Key Points: 
  • Nimbus Therapeutics , LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the closing of Takeda’s (TSE:4502/NYSE:TAK) acquisition of Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus, and its tyrosine kinase 2 (TYK2) inhibitor program, which includes the oral, selective allosteric TYK2 inhibitor NDI-034858, now known as TAK-279.
  • The completion of this acquisition triggered a $4 billion upfront payment from Takeda to Nimbus, which is also eligible to receive up to $2 billion total in sales-based milestone payments.
  • Nimbus previously announced that NDI-034858 achieved the trial’s primary efficacy endpoint, with a statistically significant greater proportion of patients reaching PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) compared to placebo at 12 weeks.
  • Nimbus retains ownership of and continues to advance a portfolio of potentially transformative therapeutics for cancer, autoimmune diseases and metabolic disorders, including NDI-101150, a selective hematopoietic progenitor kinase 1 (HPK1) inhibitor, currently being evaluated in a Phase 1/2 study in patients with solid tumors.

Evelo Biosciences Provides Clinical and Business Updates

Retrieved on: 
Wednesday, February 1, 2023
Prevalence, Geography, Food, Psoriasis Area and Severity Index, Patient, Science, EV, Trial of the century, Webcast, Medicines and Healthcare products Regulatory Agency, European Medicines Agency, Atopic dermatitis, EASI, Partnership, Clinical trial, Health care, FDA, Psoriasis, Phase 3, EMA, Workforce, Medication, MHRA, Medical imaging, Vaccine, Management, Silviculture, Pharmaceutical industry

CAMBRIDGE, Mass., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis (SINTAX) today announced updates to its clinical pipeline as well as business updates.

Key Points: 
  • ET –
    CAMBRIDGE, Mass., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis (SINTAX) today announced updates to its clinical pipeline as well as business updates.
  • Based on their feedback, we believe we have a clear path towards a global registration program for EDP1815 in psoriasis.
  • As part of this initiative, we have reduced our workforce and are prioritizing investment in our core clinical programs.
  • Evelo is in active discussions regarding partnership opportunities across EDP1815, EDP2939, as well as the EV platform.

Dong-A ST Demonstrates Therapeutic Equivalence Between DMB-3115 and Stelara in Global Phase III

Retrieved on: 
Tuesday, January 17, 2023
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MAT, Ustekinumab, Safety, IQVIA, Psoriasis, Ulcerative colitis, Intas Biopharmaceuticals, Patient, Week, Psoriasis Area and Severity Index, Psoriatic arthritis, III, USD, EMA, Pharmaceutical industry, Vaccine, EU

Dong-A ST (President and CEO: Min-young Kim) (KRX:170900) announced on January 16th that therapeutic equivalence and safety were established between DMB-3115 and Stelara, the reference drug, in global phase III.

Key Points: 
  • Dong-A ST (President and CEO: Min-young Kim) (KRX:170900) announced on January 16th that therapeutic equivalence and safety were established between DMB-3115 and Stelara, the reference drug, in global phase III.
  • DMB-3115 global phase III first kicked off in the US back in 2021 and then in eight European countries, including Poland, Estonia, and Latvia, with a total patient number of 605 over 52 weeks.
  • Patients with moderate to severe chronic plaque psoriasis were treated with DMB-3115 or Stelara PFS to compare efficacy, safety, and immunogenicity.
  • DMB-3115 and Stelara demonstrated therapeutic equivalence when looking at percent change from baseline in PASI (Psoriasis Area and Severity Index) at Week 8 and Week 12.

MoonLake Immunotherapeutics screens first patient in Phase 2 study of the Nanobody® sonelokimab in active psoriatic arthritis

Retrieved on: 
Wednesday, December 14, 2022
Inflammatory arthritis, MIRA, PASI, Veni, vidi, vici, Security (finance), Psoriatic arthritis, Adalimumab, Fatigue, Health assessment, Severity, Ageing, Research, ACR, Psoriasis Area and Severity Index, American College of Rheumatology, Inflammation, American College, Safety, Skin, Pain, Chemokine, Disability, Psoriasis, Moonlake, Securities and Exchange Commission (Philippines), Quality of life, VHH, Temperature, Trial of the century, Joint, KDA, Disease, Tissue, Patient, Swelling, Single-domain antibody, Antibody, ARGO, Hidradenitis suppurativa, Pharmaceutical industry, Vaccine, Oyster, Medical imaging, Sanofi, Ablynx

Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented: “We are very pleased to have begun the ARGO study of the Nanobody sonelokimab in the treatment of psoriatic arthritis.

Key Points: 
  • Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented: “We are very pleased to have begun the ARGO study of the Nanobody sonelokimab in the treatment of psoriatic arthritis.
  • The study will comprise approximately 200 patients, and will evaluate different doses of sonelokimab, with placebo control and adalimumab as an active reference arm.
  • Sonelokimab has been assessed in a randomized, placebo-controlled Phase 2b study in 313 patients with moderate-to-severe plaque-type psoriasis.
  • Psoriatic arthritis (PsA) is a chronic and progressive inflammatory arthritis associated with psoriasis primarily affecting the peripheral joints.

Takeda to Acquire Nimbus Therapeutics’ Highly Selective, Allosteric TYK2 Inhibitor to Address Multiple Immune-Mediated Diseases

Retrieved on: 
Tuesday, December 13, 2022
Health, Infectious Diseases, Technology, Other Technology, Clinical Trials, Pharmaceutical, Biotechnology, Therapy, TYK2, Psoriasis, HSR, HPK1, Patient, Cancer, TAK, Psoriasis Area and Severity Index, Research, Hart–Scott–Rodino Antitrust Improvements Act, MBA, Acquisition, Pharmaceutical industry, Nimbus, Takeda

Nimbus Therapeutics , LLC (Nimbus Therapeutics or Nimbus), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced that it has signed a definitive agreement under which Takeda (TSE:4502/NYSE:TAK) will acquire Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858.

Key Points: 
  • Nimbus Therapeutics , LLC (Nimbus Therapeutics or Nimbus), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced that it has signed a definitive agreement under which Takeda (TSE:4502/NYSE:TAK) will acquire Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858.
  • NDI-034858 is an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis.
  • Under the terms of the agreement, Takeda will pay Nimbus Therapeutics $4 billion upfront, and sales-based milestone payments up to $2 billion.
  • NDI-034858 is an allosteric TYK2 inhibitor discovered and developed by Nimbus Therapeutics that is being evaluated for the treatment of multiple autoimmune diseases.