Psoriasis Area and Severity Index

SFA Therapeutics Announces Updated Psoriasis Data for SFA-002, Bridge Financing, and Foundational Patent

Retrieved on: 
Thursday, November 9, 2023
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Additional participants in this raise were the Ben Franklin Technology Partners of Pennsylvania, Savantus Ventures and Asymmetry Ventures.

Key Points: 
  • Additional participants in this raise were the Ben Franklin Technology Partners of Pennsylvania, Savantus Ventures and Asymmetry Ventures.
  • SFA-002 is an oral pill that simultaneously acts on multiple therapeutic pathways, unlike other drugs on the market which target a single channel.
  • SFA Therapeutics is also pleased to announce that North South Ventures Managing Partner, Dr. David Naylor, MD/PhD, OC, FRCPC, FRSC, has joined SFA Therapeutics’ Board of Directors.
  • Psoriasis is an incurable chronic disease that affects 125 million people worldwide, with the global psoriasis treatment market size projected to grow at a CAGR of 9.2%.

Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational, Oral, Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023
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These data ( Abstract #L12 ) will be presented on Tuesday, November 14 as part of the late-breaking poster session from 9:00 AM - 11:00 AM PT at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, California.

Key Points: 
  • These data ( Abstract #L12 ) will be presented on Tuesday, November 14 as part of the late-breaking poster session from 9:00 AM - 11:00 AM PT at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, California.
  • There was no clinically significant difference in adverse event rates between doses of TAK-279.
  • “We are also advancing the development of TAK-279 in Crohn’s disease, ulcerative colitis and systemic lupus erythematosus and exploring a range of other potential indications.
  • These opportunities are being explored in parallel with the psoriasis and psoriatic arthritis programs.”

Ventyx Biosciences Announces Results from the Phase 2 Trial of VTX958 in Patients with Moderate to Severe Plaque Psoriasis and Provides Corporate Update

Retrieved on: 
Monday, November 6, 2023
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Although the trial achieved its primary endpoint, the magnitude of efficacy observed did not meet our internal target to support advancement of VTX958 in plaque psoriasis.

Key Points: 
  • Although the trial achieved its primary endpoint, the magnitude of efficacy observed did not meet our internal target to support advancement of VTX958 in plaque psoriasis.
  • Accordingly, we will terminate ongoing activities in the Phase 2 plaque psoriasis trial effective immediately.
  • Based on these results, we have also elected to terminate the ongoing Phase 2 trial of VTX958 in psoriatic arthritis.
  • ET to discuss the results from the Phase 2 trial of VTX958 in patients with moderate to severe plaque psoriasis.

New Data Shows ZORYVE® (Roflumilast) Cream 0.3% Provided Measurable Improvement of Plaque Psoriasis in Nearly All Individuals in DERMIS Trials

Retrieved on: 
Friday, October 20, 2023
Week, Psoriasis, Conference, Patient, PASI, Psoriasis Area and Severity Index, Pharmaceutical industry

Separately reported investigator and patient local tolerability assessment data confirms again that ZORYVE was well tolerated from first application.

Key Points: 
  • Separately reported investigator and patient local tolerability assessment data confirms again that ZORYVE was well tolerated from first application.
  • ZORYVE is a once-daily, steroid-free cream for individuals with plaque psoriasis down to 6 years of age that can be used for any duration across all affected areas of the body.
  • “Data reported from clinical trials generally show results within the overall study population which is certainly important.
  • Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients with Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis

Evelo Biosciences Announces Top-Line Results From its Phase 2 Clinical Study with EDP2939 in Moderate Psoriasis

Retrieved on: 
Tuesday, October 17, 2023
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CAMBRIDGE, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO) (“Evelo” or the “Company”), a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis (SINTAX), today announced top-line results from its Phase 2 clinical study with EDP2939 in moderate psoriasis. The study’s primary endpoint, the difference in the proportion of patients who achieved an outcome of a 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) score (a PASI-50 response) between EDP2939 and placebo after 16 weeks of daily treatment, was not achieved. The Company is continuing to gather and analyze the study data.

Key Points: 
  • CAMBRIDGE, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO) (“Evelo” or the “Company”), a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis (SINTAX), today announced top-line results from its Phase 2 clinical study with EDP2939 in moderate psoriasis.
  • We previously reported positive efficacy and safety data in a Phase 2 study of mild to moderate psoriasis with EDP1815.
  • A PASI-50 response was chosen as this is clinically meaningful for patients with moderate psoriasis and had been positive in the previous study with EDP1815.
  • Overall safety data was consistent with what was previously reported in the Phase 1 portion of this study: EDP2939 was well-tolerated with adverse events (AEs) comparable to placebo.

Press Release: Late-breaking amlitelimab Phase 2b data presented at EADV show potential best-in-class profile in atopic dermatitis

Retrieved on: 
Friday, October 13, 2023
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The Phase 3 program for amlitelimab in atopic dermatitis is on track to start in the first half of 2024.

Key Points: 
  • The Phase 3 program for amlitelimab in atopic dermatitis is on track to start in the first half of 2024.
  • Global Head of Research & Development, Sanofi
    “The data presented at EADV provide more detailed insight into amlitelimab’s potential as a best-in-class therapy for people with atopic dermatitis.
  • TEAEs more commonly observed with amlitelimab compared to placebo included nasopharyngitis (11.0% amlitelimab, 9.0% placebo), COVID-19 (7.7% amlitelimab, 6.4% placebo) and headache (6.1% amlitelimab, 2.6% placebo).
  • Worsening of atopic dermatitis was more commonly observed with placebo compared to amlitelimab (38.5% placebo, 17.1% amlitelimab).

Dermavant to Present New Positive Data from Phase 4, Open Label Trial of VTAMA® (tapinarof) Cream, 1% for Intertriginous Plaque Psoriasis in Adults and Multiple Clinical Trials of VTAMA cream at the 2023 Fall Clinical Dermatology Conference

Retrieved on: 
Monday, October 16, 2023
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On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of adult plaque psoriasis.

Key Points: 
  • On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of adult plaque psoriasis.
  • The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years.
  • The poster will present data from the Phase 4, open-label trial that evaluated the efficacy and safety of VTAMA (tapinarof) cream, 1% for intertriginous plaque psoriasis in adults (N=34).
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Almirall's Lebrikizumab Improves Signs and Symptoms of Moderate-to-Severe Atopic Dermatitis (AD) in Patients Inadequately Controlled With or Ineligible for Cyclosporine1

Retrieved on: 
Friday, October 13, 2023
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Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared.

Key Points: 
  • Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.
  • Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe AD in additional European markets, including the United Kingdom and Switzerland in 2024.
  • † More information about the Phase 3 studies: ADvocate 1: EudraCT Number 2019-002932-10; NCT04146363; ADvocate 2: EudraCT Number 2019-002933-12; NCT04178967; ADhere: EudraCT Number 2019-004300-34; NCT04250337

Meiji Seika Pharma Presents Positive Findings from Phase II Study of ME3183, Novel Highly-Potent Selective PDE4 Inhibitor, in Patients With Plaque Psoriasis at EADV Congress 2023

Retrieved on: 
Friday, October 13, 2023
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In total, 132 patients were randomly assigned to ME3183 (n=26, 26, 26, and 27, respectively) or placebo (n=27).

Key Points: 
  • In total, 132 patients were randomly assigned to ME3183 (n=26, 26, 26, and 27, respectively) or placebo (n=27).
  • Mean Psoriasis Area and Severity Index (PASI) score at baseline was 15.9–17.6 and 16.8 in the ME3183 and placebo groups, respectively.
  • In conclusion, ME3183 administered orally was effective in the treatment of plaque psoriasis and had an acceptable safety profile.
  • Meiji strives to provide efficacious and safe treatment for unmet medical needs, such as psoriasis and other autoimmune diseases.

Sotyktu (deucravacitinib) Long-Term Data Demonstrate Durable Efficacy and Consistent Safety for up to Three Years in Moderate-to-Severe Plaque Psoriasis

Retrieved on: 
Wednesday, October 11, 2023
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Bristol Myers Squibb (NYSE:BMY) today announced new three-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis.

Key Points: 
  • Bristol Myers Squibb (NYSE:BMY) today announced new three-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis.
  • Sotyktu demonstrated a consistent safety profile with no increases in the rates of adverse events (AEs) or serious AEs over time, and no emergence of any new safety signals.
  • The efficacy analysis assessed 513 patients who received continuous Sotyktu treatment from Day 1 in the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned to the LTE trial.
  • “These new data validate the potential of Sotyktu to provide long-term, clinically relevant improvement for individuals living with moderate-to-severe plaque psoriasis.”
    Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program.