Psoriasis Area and Severity Index

DICE Therapeutics Announces Positive Topline Data from Phase 1 Clinical Trial of Lead Oral IL-17 Antagonist, DC-806, for Psoriasis

Retrieved on: 
Tuesday, October 11, 2022

SOUTH SAN FRANCISCO, Calif., Oct. 11, 2022 (GLOBE NEWSWIRE) -- DICE Therapeutics, Inc. (Nasdaq: DICE), a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas, today announced positive topline data from its Phase 1 clinical trial of DC-806, an oral small molecule antagonist of the pro-inflammatory cytokine IL-17. The trial was a first-in-human, randomized, double-blind, placebo-controlled study designed to generate safety and pharmacokinetic (PK) data in healthy volunteers as well as provide early clinical proof-of-concept in psoriasis patients. The trial was conducted in three overlapping parts: Phase 1a single ascending dose (SAD) (n=40); Phase 1b multiple ascending dose (MAD) (n=32); and Phase 1c proof-of-concept in psoriasis patients (n=32).

Key Points: 
  • The trial was conducted in three overlapping parts: Phase 1a single ascending dose (SAD) (n=40); Phase 1b multiple ascending dose (MAD) (n=32); and Phase 1c proof-of-concept in psoriasis patients (n=32).
  • Based on the Phase 1 clinical trial, we believe DC-806 has the potential to be the best-in-class oral therapeutic agent for patients with psoriasis, said Tim Lu, M.D., Ph.D., chief medical officer of DICE Therapeutics.
  • Data from this Phase 1 clinical trial provide early evidence for the potential differentiation of DC-806 on efficacy, safety, and ease of use.
  • DICE plans to advance DC-806 into a dose-ranging Phase 2b clinical trial in patients with moderate-to-severe psoriasis.

Alumis Announces Initiation of Patient Dosing in Phase 2 Clinical Trial of ESK-001 for the Treatment of Plaque Psoriasis

Retrieved on: 
Wednesday, September 28, 2022

Initiation of the Phase 2 trial is supported by data from Phase 1 studies in more than 100 healthy volunteers.

Key Points: 
  • Initiation of the Phase 2 trial is supported by data from Phase 1 studies in more than 100 healthy volunteers.
  • Across the Phase 1 program, ESK-001 was generally well-tolerated, with no serious adverse events observed.
  • ESK-001 has the potential to offer an oral therapy with superior efficacy compared to other available or investigational treatments for plaque psoriasis.
  • The Stride trial is a randomized, double-blind, placebo-controlled Phase 2 dose ranging trial that will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of ESK-001 in patients with moderate to severe plaque psoriasis.

MoonLake Immunotherapeutics to initiate global Phase 2 study of the Nanobody® sonelokimab in patients with active psoriatic arthritis

Retrieved on: 
Monday, September 26, 2022

Sonelokimab (M1095) is an investigational Nanobody designed to treat inflammatory disease by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation.

Key Points: 
  • Sonelokimab (M1095) is an investigational Nanobody designed to treat inflammatory disease by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation.
  • The ARGO study (M1095-PSA-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobody sonelokimab, administered subcutaneously, in the treatment of adult patients with active 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.
  • MoonLake Immunotherapeutics AG is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory disease, to revolutionize outcomes for patients.

Can-Fite: New Phase III Psoriasis Data Showing Superior Safety & Improved Efficacy Presented by KOL Dr. Papp at the 31st European Academy of Dermatology

Retrieved on: 
Monday, September 12, 2022

Can-Fite previously reported the COMFORT study met its primary endpoint with Piclidenoson showing a statistically significant improvement over placebo in psoriasis patients.

Key Points: 
  • Can-Fite previously reported the COMFORT study met its primary endpoint with Piclidenoson showing a statistically significant improvement over placebo in psoriasis patients.
  • The K. Papp Clinical Research center is considered one of the top clinical research centers in the world.
  • The COMFORT CF101-301PS, is a Phase III randomized, double-blind, placebo- and active-controlled study of the efficacy and safety of daily Piclidenoson (CF101) administered orally in patients with moderate-to-severe plaque psoriasis.
  • The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis.

Can-Fite Reports Second Quarter 2022 Financial Results & Provides Clinical Update

Retrieved on: 
Thursday, August 25, 2022

(NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the quarter ended June 30, 2022.

Key Points: 
  • (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the quarter ended June 30, 2022.
  • Corporate and Clinical Development Highlights Include:
    Strong Balance Sheet - On June 30, 2022, Can-Fite had approximately $12.72 million in cash, cash equivalents, and short-term deposits.
  • Phase III COMFORT Trial for Psoriasis Meets Primary Endpoint Topline results were announced during the second quarter, and further data are expected in the coming weeks.
  • The Company's consolidated financial results for the six months ended June 30, 2022 are presented in accordance with US GAAP Reporting Standards.

Dermavant to Present New Data from Phase 3 Trial Program of VTAMA® (tapinarof) cream, 1% for Adults with Plaque Psoriasis at the 2022 EADV Congress

Retrieved on: 
Wednesday, August 24, 2022

VTAMA cream is approved for mild, moderate and severe plaque psoriasis, with no label restrictions on duration of use or body surface area.

Key Points: 
  • VTAMA cream is approved for mild, moderate and severe plaque psoriasis, with no label restrictions on duration of use or body surface area.
  • Indication: VTAMA (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.
  • Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80 to 90% of people with psoriasis.
  • The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022.

Can-Fite Selected to Present the Positive Psoriasis Phase III Data at the 31st European Academy of Dermatology and Venerology Congress

Retrieved on: 
Monday, August 22, 2022

The K. Papp Clinical Research center is considered one of the top clinical research centers in the world.

Key Points: 
  • The K. Papp Clinical Research center is considered one of the top clinical research centers in the world.
  • As we continue to analyze the data from our COMFORT study, we are gaining additional insight into Piclidenosons efficacy and safety.
  • Upon completing the latest sub-analysis, we look forward to Dr. Papp presenting new data at EADV, stated Can-Fite CEO Dr. Fishman.
  • The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis.

DGAP-News: Formycon's Biosimilar Ustekinumab Candidate FYB202 Shows Comparable Efficacy to Reference Product Stelara®* in Phase III Study

Retrieved on: 
Tuesday, August 16, 2022

The multi-center, randomized, double-blinded, comparative clinical study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB202 and the reference medicine Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

Key Points: 
  • The multi-center, randomized, double-blinded, comparative clinical study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB202 and the reference medicine Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).
  • The primary endpoint of the comparative global Phase III study measures the percent improvement of the Psoriasis Area and Severity Index (PASI) at 12 weeks from baseline.
  • The values obtained for FYB202 and reference product are within the relevant equivalence limits.
  • The positive interim phase III study results mark an important milestone and underline our expertise in the development of high-quality biosimilars."

STELARA® (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis

Retrieved on: 
Monday, August 1, 2022

HORSHAM, Pa., Aug. 1, 2022 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA). This rare disease that resembles adult PsA affects five to eight percent of children and adolescents with chronic inflammatory arthritis.*1-7 Two of the four indications for STELARA now include pediatric patients, further expanding its treatment profile since the first approval in 2009 for adults living with moderate to severe plaque psoriasis (PsO).

Key Points: 
  • This rare disease that resembles adult PsA affects five to eight percent of children and adolescents with chronic inflammatory arthritis.
  • STELARA is administered as a subcutaneous injection dosed four times per year after two starter doses for the treatment of pediatric patients six years of age and older with active PsA.
  • STELARA withMe offers a comprehensive support program that helps patients get started on STELARA and stay on track.
  • Active psoriatic arthritis (PsA) in pediatric patients, a rare disease that resembles adult PsA, affects five to eight percent of children and adolescents with chronic inflammatory arthritis.

LEO Pharma Announces Publication of Adbry™ (tralokinumab-ldrm) Efficacy Data in Moderate-to-Severe Atopic Dermatitis in American Journal of Clinical Dermatology

Retrieved on: 
Wednesday, July 20, 2022

LEO Pharma A/S, a global leader in medical dermatology, today announced that American Journal of Clinical Dermatology published 32-week results from a post-hoc analysis of the Phase 3 ECZTRA 3 clinical trial (NCT03363854) in atopic dermatitis (AD).

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced that American Journal of Clinical Dermatology published 32-week results from a post-hoc analysis of the Phase 3 ECZTRA 3 clinical trial (NCT03363854) in atopic dermatitis (AD).
  • The results provide additional context around the benefits of Adbry, including impact on measures that are important to clinicians and patients and, ultimately, may help inform clinical decisions.
  • ADBRY can cause serious side effects including:
    Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis.
  • Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: