Psoriasis Area and Severity Index

Dermavant to Present Data from ADORING 1 and 2 Pivotal Phase 3 Trials of VTAMA® (tapinarof) cream, 1% for Adults and Children as Young as 2 Years Old with Atopic Dermatitis at the 2023 EADV Congress

Retrieved on: 
Friday, October 6, 2023
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The following late-breaking oral presentations will be presented live during the Late Breaking News sessions on October 11 and October 12, 2023 and will be available on the EADV virtual platform.

Key Points: 
  • The following late-breaking oral presentations will be presented live during the Late Breaking News sessions on October 11 and October 12, 2023 and will be available on the EADV virtual platform.
  • This oral presentation will include data on the efficacy endpoints that evaluated itch relief of VTAMA® (tapinarof) cream, 1% once daily (QD) in ADORING 1 and 2 based on mean daily and mean weekly changes in Peak Pruritus Numeric Rating Scale (PP-NRS) scores through Week 8.
  • You are encouraged to report negative side effects of prescription drugs to the FDA.
  • Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Nektar Presents New Responder Data for Rezpegaldesleukin, a First-in-Class Selective Regulatory T-cell Therapy, in Late-Breaking News Oral Presentation at 2023 EADV Congress

Retrieved on: 
Friday, October 13, 2023
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SAN FRANCISCO, Oct. 13, 2023  /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today announced new data for rezpegaldesleukin (REZPEG), a first-in-class selective regulatory T-cell (Treg) therapy, in patients with atopic dermatitis (AD) at the 2023 European Academy of Dermatology and Venereology (EADV) Congress. These data were presented by Dr. Jonathan Silverberg, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Director of Clinical Research and Contact Dermatitis in a late-breaking oral presentation.

Key Points: 
  • "Data from this presentation demonstrate consistent benefit with REZPEG across multiple clinician and patient-reported outcomes, which were maintained through 36 weeks after treatment ended," said Dr. Jonathan Silverberg.
  • "The sustained post-treatment benefit observed with REZPEG has the potential to alter the need for frequent maintenance dosing for patients with atopic dermatitis.
  • Based on these data, the company is initiating two Phase 2 studies in atopic dermatitis and in alopecia areata.
  • Highlight of the new patient-reported outcomes for the Phase 1b study in atopic dermatitis presented at EADV 2023 for the first time:

Kyowa Kirin Announces Three Abstracts and A Symposium at the European Academy of Dermatology and Venereology Congress 2023

Retrieved on: 
Wednesday, October 11, 2023
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Often beginning in childhood, AD affects 15-20% of children and up to 10% of adults, making it the 15th most common nonfatal disease.

Key Points: 
  • Often beginning in childhood, AD affects 15-20% of children and up to 10% of adults, making it the 15th most common nonfatal disease.
  • "We are pleased to share this additional data from the rocatinlimab Phase 2b study," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin.
  • "It provides further insight into the potential of rocatinlimab in treating patients living with moderate-to-severe atopic dermatitis.
  • EASI lichenification scores were assessed separately for the following body regions: head and neck (H&N), trunk, upper limbs, and lower limbs.

Janssen Highlights Latest Research for TREMFYA® (guselkumab) and Investigational Targeted Oral Peptide JNJ-2113 in Moderate to Severe Plaque Psoriasis at the European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Monday, October 9, 2023
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SPRING HOUSE, Pa., Oct. 9, 2023 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, today announced that 30 company-sponsored presentations will be featured at the European Academy of Dermatology and Venereology (EADV) Congress taking place in Berlin, Germany from October 11-14, 2023. Janssen will present new data on the underlying science of the treatment of psoriasis (PsO), including results from the Phase 3b GUIDE trial highlighting early intervention with TREMFYA® (guselkumab) (Abstract #FC08.5)1 and systemic pharmacodynamica response data for JNJ-2113 from the Phase 2 FRONTIER 1 trial (Abstract #FC08.2).2

Key Points: 
  • "Patients are waiting for a new option with the goal of helping manage their plaque psoriasis symptoms, which could potentially transform the treatment paradigm.
  • The data from these presentations add to the comprehensive body of scientific evidence for our investigational and established therapies, potentially offering people living with moderate to severe plaque psoriasis much-needed relief from their symptoms."
  • A selection of Janssen-sponsored abstracts being featured at EADV is provided below.
  • Systemic pharmacodynamics is the study of the biochemical and physiologic effects of drugs in the body.

Galapagos announces start of Phase 2 study with selective TYK2 inhibitor, GLPG3667, in patients with active systemic lupus erythematosus  

Retrieved on: 
Monday, August 28, 2023
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Mechelen, Belgium; 28 August 2023, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the first patient was randomized in GALACELA, a Phase 2 systemic lupus erythematosus (SLE) trial with GLPG3667.

Key Points: 
  • Mechelen, Belgium; 28 August 2023, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the first patient was randomized in GALACELA, a Phase 2 systemic lupus erythematosus (SLE) trial with GLPG3667.
  • The GALACELA Phase 2 trial ( NCT05856448 ) is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3667 in adults with active SLE.
  • A once-daily oral administration of GLPG3667 or placebo will be investigated in approximately 140 adult patients with SLE for 32 weeks.
  • The primary endpoint is the proportion of patients who achieve the SLE responder index (SRI)-4 response at Week 32.

SFA Therapeutics announces results for SFA-002 from Phase 1b Cohort 1 clinical trial for treatment of mild-to-moderate psoriasis

Retrieved on: 
Monday, August 14, 2023
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JENKINTOWN, Pa., Aug. 14, 2023 (GLOBE NEWSWIRE) -- SFA Therapeutics, a clinical-stage biotech using a first-in-class immuno-modulation technology platform, announced positive results from their SFA-002 Phase 1b cohort 1 clinical trial.

Key Points: 
  • JENKINTOWN, Pa., Aug. 14, 2023 (GLOBE NEWSWIRE) -- SFA Therapeutics, a clinical-stage biotech using a first-in-class immuno-modulation technology platform, announced positive results from their SFA-002 Phase 1b cohort 1 clinical trial.
  • SFA’s oral pill SFA-002 has the potential to be disease-modifying, with durable responses and an excellent safety profile.
  • The Phase 1b clinical trial of SFA-002 in mild-to-moderate chronic plaque psoriasis is an open label prospective study of 2 different dosage forms, in two cohorts.
  • No related adverse events or toxicities were observed during the treatment period and follow-up, and no rebound effects were observed
    The second cohort of the Phase 1b clinical trial is ongoing (ClinicalTrials.gov Identifier: NCT05642182).

MoonLake Immunotherapeutics Reports Second Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Thursday, August 10, 2023
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Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “This quarter has been transformational for MoonLake.

Key Points: 
  • Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “This quarter has been transformational for MoonLake.
  • Second Quarter 2023 Financial Highlights:
    On June 30, 2023, MoonLake closed a public offering of 8,000,000 Class A Ordinary Shares at a public offering price of $50.00 per Share.
  • Research and development expenses for the quarter ended June 30, 2023, were $8.7 million, compared to $7.4 million in the previous quarter.
  • General and administrative expenses for the quarter ended June 30, 2023, were $4.5 million, compared to $5.5 million in the previous quarter.

Bristol Myers Squibb Launches Clear Understanding Campaign to Reveal the Plain Truth About Living with Moderate to Severe Plaque Psoriasis

Retrieved on: 
Tuesday, August 8, 2023
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View the full release here: https://www.businesswire.com/news/home/20230804756518/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230804756518/en/
    Nitika, living with moderate to severe plaque psoriasis.
  • (Photo: Bristol Myers Squibb)
    “I was young when I was diagnosed with moderate to severe plaque psoriasis, and it felt like my whole life revolved around my condition.
  • “This insight drove us to launch the Clear Understanding campaign to recognize those concessions and encourage people living with moderate to severe plaque psoriasis to talk to their dermatologist about available treatment options."
  • In two studies of moderate to severe plaque psoriasis, Sotyktu was compared to placebo and Otezla® (apremilast).

Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar

Retrieved on: 
Tuesday, August 1, 2023
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INCHEON, South Korea and JERSEY CITY, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira® (adalimumab).

Key Points: 
  • INCHEON, South Korea and JERSEY CITY, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira® (adalimumab).
  • The primary objective of the study was to assess the pharmacokinetic similarity between two treatment groups: patients with moderate to severe plaque psoriasis who switched multiple times between Humira (ADL) and high-concentration SB5 versus patients receiving ADL continuously.
  • All 371 patients who were enrolled in the study had no prior treatment with ADL and were treated in this study with ADL during a lead-in period of 13 weeks.
  • HADLIMA was introduced into the U.S. commercial market on July 1, 2023 and is marketed by Organon.

MoonLake completes patient randomization ahead of schedule for its Phase 2 trial in active psoriatic arthritis (PsA) and provides calendar of next readouts  

Retrieved on: 
Tuesday, July 25, 2023
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MoonLake also announced a Capital Markets Day to be held in New York at NASDAQ, including a virtual webcast format, on September 11th 2023.

Key Points: 
  • MoonLake also announced a Capital Markets Day to be held in New York at NASDAQ, including a virtual webcast format, on September 11th 2023.
  • Jorge Santos da Silva, PhD, Founder and Chief Executive Officer at MoonLake, said: “ARGO is MoonLake’s second trial to have achieved faster completion of recruitment and randomization than expected.
  • Reaching this stage well ahead of schedule for active psoriatic arthritis is an encouraging reflection of the interest in our clinical development programs.
  • The trial also includes adalimumab, the current standard of care for PsA, as an active reference arm.