Psoriasis Area and Severity Index

Nimbus Therapeutics Presents Clinical Data from Phase 1b Study of Oral Allosteric TYK2 Inhibitor at AAD Annual Meeting

Retrieved on: 
Friday, March 25, 2022
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Nimbus Therapeutics , a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today presented data from the Phase 1b clinical trial of its investigational oral allosteric tyrosine kinase 2 (TYK2) inhibitor, NDI-034858, in patients with moderate-to-severe plaque psoriasis at the 2022 American Academy of Dermatology (AAD) Annual Meeting.

Key Points: 
  • Nimbus Therapeutics , a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today presented data from the Phase 1b clinical trial of its investigational oral allosteric tyrosine kinase 2 (TYK2) inhibitor, NDI-034858, in patients with moderate-to-severe plaque psoriasis at the 2022 American Academy of Dermatology (AAD) Annual Meeting.
  • As a Phase 1 study, the primary objective was evaluation of safety, and NDI-034858 was observed to be generally well tolerated.
  • The poster, titled Analysis of histologic, molecular and clinical improvement in moderate-to-severe psoriasis: Results from a Phase 1b trial of the novel allosteric TYK2 inhibitor NDI-034858, is on display through March 27, 2022.
  • Nimbus is conducting two clinical studies to evaluate its novel allosteric TYK2 inhibitor, including an ongoing moderate-to-severe plaque psoriasis (NCT04999839) study and the recently initiated active psoriatic arthritis (NCT05153148) study.

LEO Pharma Presents New Interim Long-Term Safety and Efficacy Data for Adbry™ (tralokinumab-ldrm) in Moderate-to-Severe Atopic Dermatitis at the 2022 AAD Annual Meeting

Retrieved on: 
Friday, March 25, 2022
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LEO Pharma A/S, a global leader in medical dermatology, today announced up to 3.5-year data that further support the long-term safety and efficacy profile of Adbry (tralokinumab-ldrm) in adult patients with moderate-to-severe atopic dermatitis (AD).

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced up to 3.5-year data that further support the long-term safety and efficacy profile of Adbry (tralokinumab-ldrm) in adult patients with moderate-to-severe atopic dermatitis (AD).
  • The latest interim safety and efficacy findings are similar to earlier reports and continue to reinforce the rationale for treatment specifically targeting IL-13 in adult patients with moderate-to-severe atopic dermatitis.
  • The modified non-responder imputation and last observation carried forward analyses were also reported in the poster and results were comparable across the three analyses.
  • Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

Dermavant to Present New Data from the Phase 3 PSOARING 3 Long-Term Extension Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022 American Academy of Dermatology Annual Meeting

Retrieved on: 
Friday, March 11, 2022
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Cream, People, Atopic dermatitis, Safety, Hypertension, Psoriasis Area and Severity Index, Ageing, Twitter, Psoriasis, American Academy, AAD, Patient, QD, Risk, Boston Convention and Exhibition Center, Research, Therapy, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PGA, Diabetes, BSA, Exhibition, Quality of life, Depression, DLQI, Acne, Roivant Sciences, Dermatology Life Quality Index, Efficiency, Obesity, PDUFA, Skin, Vitiligo, Week, PASI, Inflammatory bowel disease, Food, Adult, LinkedIn, New Drug Application, Pharmaceutical industry, Cosmetics, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

Tapinarof is a novel, non-steroidal, once-daily therapeutic aryl hydrocarbon receptor modulating agent which is formulated in a cosmetically elegant cream.

Key Points: 
  • Tapinarof is a novel, non-steroidal, once-daily therapeutic aryl hydrocarbon receptor modulating agent which is formulated in a cosmetically elegant cream.
  • In August 2021, the U.S. Food and Drug Administration (FDA) accepted for filing the companys New Drug Application for tapinarof for the treatment of plaque psoriasis in adults.
  • PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

Durable and Deepening Clinical Responses Observed in Post-Treatment Period of Evelo Bioscience’s Phase 2 Clinical Trial of Oral EDP1815 in Psoriasis

Retrieved on: 
Monday, February 28, 2022
Compliance, Psoriasis Area and Severity Index, Oral medicine, Failure, COVID-19, KOL, Scalp, Private Securities Litigation Reform Act, Research, Incidence, PGA, Depression, Risk, Growth, Inflammation, Atopic dermatitis, Safety, Disease, Skin, Fatigue, Capsule, Doctor of Philosophy, Population, Immune system, FAAD, Psoriasis, Journal of Transportation Engineering, Part B: Pavements, Confidentiality, Patient, Arthritis, GLOBE, Production part approval process, Ownership, Investor, Perelman School of Medicine at the University of Pennsylvania, Association, University, Associate, Adult, Metabolic syndrome, Preclinical development, FDA, T helper cell, Marketing, MD, Dermatology Life Quality Index, SEC, Pharmaceutical industry, Dermatology, Part

CAMBRIDGE, Mass., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing SINTAX™ medicines as a new modality of orally delivered treatments for inflammatory disease, today announced data from the post-treatment follow-up (Part B) of its Phase 2 trial of EDP1815 in mild and moderate psoriasis which included durable and deeper clinical responses. EDP1815 is an investigational oral biologic currently in development for the treatment of a broad range of inflammatory diseases, including clinical programs in psoriasis, atopic dermatitis, and COVID-19.

Key Points: 
  • EDP1815 is an investigational oral biologic currently in development for the treatment of a broad range of inflammatory diseases, including clinical programs in psoriasis, atopic dermatitis, and COVID-19.
  • With the clinical responses and safety and tolerability results comparable to placebo observed in trials involving over 450 patients to-date, we look forward to advancing EDP1815 towards Phase 3 clinical trials.
  • These durable results were achieved without any new psoriasis medication being used during this time.
  • These data, combined with the durability data, suggest that longer dosing could lead to further deepening of the responses in some patients.

AOBiome Therapeutics' topical biotherapeutic B244 demonstrated positive Phase 2b results from its 547 patient trial for both Pruritus (Itch) and Appearance in its 547 patient Phase 2b trial of Atopic Dermatitis (Eczema)

Retrieved on: 
Tuesday, February 22, 2022
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The trial enrolled 547 patients with mild-to-moderate appearance of atopic dermatitis and moderate-to-severe itch.

Key Points: 
  • The trial enrolled 547 patients with mild-to-moderate appearance of atopic dermatitis and moderate-to-severe itch.
  • B244 was well tolerated with no SAEs; treatment related treatment emergent adverse events (TEAEs) were low in incidence, mild in severity, and transient.
  • Additionally, endpoints of Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) for Atopic Dermatitis were captured.
  • Patients with mild to moderate atopic dermatitis can exhibit moderate to severe pruritus which is inadequately addressed by available therapies.

Evelo Biosciences Announces Highly Significant Reductions in Clinically Validated Inflammatory Cytokines in EDP1815 Phase 2 Psoriasis Trial

Retrieved on: 
Monday, February 7, 2022
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Evelo previously reported reductions in inflammatory cytokines in a Phase 1b trial of EDP1815 in mild and moderate psoriasis.

Key Points: 
  • Evelo previously reported reductions in inflammatory cytokines in a Phase 1b trial of EDP1815 in mild and moderate psoriasis.
  • These data have now been replicated in the Phase 2 psoriasis trial, with high statistical significance.
  • There was no worsening compared to placebo on the right of the distributions, resulting in the overall significant difference between EDP1815 and placebo.
  • In the Phase 2 trial, EDP1815 was observed to have safety and tolerability data comparable to placebo.

U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis

Retrieved on: 
Friday, January 21, 2022
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"We're proud to expand the use of SKYRIZI to patients with psoriatic arthritis who are living with the debilitating combination of skin and joint symptoms."

Key Points: 
  • "We're proud to expand the use of SKYRIZI to patients with psoriatic arthritis who are living with the debilitating combination of skin and joint symptoms."
  • SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally.
  • The overall safety profile observed in patients with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in patients with plaque psoriasis.
  • Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Friday, January 14, 2022
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Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin.

Key Points: 
  • Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin.
  • We appreciate Pfizers commitment to this resilient patient community and eagerly await the positive impact CIBINQO could have on the treatment landscape for moderate-to-severe atopic dermatitis.
  • Five clinical trials in the CIBINQO JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program were included in the New Drug Application (NDA) to support the FDA approval.
  • Atopic dermatitis in America study: a cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population.

U.S. FDA Approves RINVOQ® (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis

Retrieved on: 
Friday, January 14, 2022
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RINVOQ is also approved in the EU for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis.

Key Points: 
  • RINVOQ is also approved in the EU for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis.
  • RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.
  • It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
  • If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.

LEO Pharma announces FDA approval of Adbry™ (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis

Retrieved on: 
Tuesday, December 28, 2021
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Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.

Key Points: 
  • Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.
  • Its exciting to see a new targeted therapeutic option for adult patients living with moderate-to-severe atopic dermatitis.
  • The FDA approval marks the fifth global regulatory approval for tralokinumab in 2021.
  • Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: