Psoriasis Area and Severity Index

 Can-Fite Announces Positive Top-Line Results from Piclidenoson Phase III COMFORT™ Study in Moderate to Severe Psoriasis

Retrieved on: 
Wednesday, June 29, 2022
Biotechnology, General Health, Finance, Health, Professional Services, CANF, PDI, Patient, Cancer, Institute of Liver and Biliary Sciences, Psoriasis Area and Severity Index, TASE, Safety, PASI, Psoriasis, NYSE, Pharmaceutical industry, Medical imaging

The study data show that patients treated with oral Piclidenoson 2 mg or 3 mg twice daily, had clinically equivalent efficacy responses.

Key Points: 
  • The study data show that patients treated with oral Piclidenoson 2 mg or 3 mg twice daily, had clinically equivalent efficacy responses.
  • Piclidenoson had an excellent safety profile overlapping that of the placebo treated patients, showing a better safety profile when compared to Otezla.
  • Full results from the COMFORT Phase III study will be presented at an upcoming medical conference and published in a peer-reviewed medical journal.
  • 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.

Press Release: FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

Retrieved on: 
Tuesday, June 7, 2022
Caregiver, Siliceous ooze, Human, Regeneron Pharmaceuticals, Safety, Food, Ageing, Conditional sentence, Disease, Atopic dermatitis, Itch, Pain, Red, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Priority review, FDA, Bleeding, TCS, Patient, Risk, Review, Immune system, European Medicines Agency, Association, Skin, Population, Rash, Crust (geology), IGA, Psoriasis Area and Severity Index, Management, Vaccine, Birth control, Dietary supplement, Dupilumab

In the U.S., more than 75,000 children aged 5 years and younger have uncontrolled moderate-to-severe disease and are most in need of new treatment options.

Key Points: 
  • In the U.S., more than 75,000 children aged 5 years and younger have uncontrolled moderate-to-severe disease and are most in need of new treatment options.
  • These young people, and their families, often struggle to cope with the significant impact itch can have on them.
  • This approval means that Dupixent, with its well-established safety and efficacy profile, is now available to some of the youngest people living with this disease.
  • The safety profile of Dupixent observed through 16 weeks in children aged 6 months to 5 years was similar to the safety profile in patients 6 years and older with atopic dermatitis.

FDA Approves Dupixent® (dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis

Retrieved on: 
Tuesday, June 7, 2022
Caregiver, Siliceous ooze, M.D, Human, Regeneron Pharmaceuticals, Safety, International development, Food, Child, Ageing, Conditional sentence, Disease, Atopic dermatitis, Itch, Pain, Senior, Red, Priority review, FDA, Bleeding, TCS, Patient, Immune system, Quality of life, NASDAQ, European Medicines Agency, Association, Population, Inflammation, Crust (geology), IGA, Skin, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Psoriasis Area and Severity Index, Vaccine, Dietary supplement, Birth control, Sanofi, Dupilumab

TARRYTOWN, N.Y. and PARIS, June 7, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Regulatory filings for this age group are underway by the European Medicines Agency and regulatory authorities in additional countries.

Key Points: 
  • Moderate-to-severe atopic dermatitis may also significantly impact the quality of life of a young child and their caregivers.
  • The safety profile of Dupixent observed through 16 weeks in children aged 6 months to 5 years was similar to the safety profile in patients 6 years and older with atopic dermatitis.
  • In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home.
  • It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age.

RAPT Therapeutics Announces Initiation of Phase 2b Trial of RPT193 in Patients with Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Monday, May 23, 2022
Inflammation, American Academy, Polyp (medicine), Disease, Numerical, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, Viga, Asthma, Ligand, Incidence, Sinusitis, Eczema Area and Severity Index, Patient, Body surface area, RAPT, Dermatology, Quality of life, Therapy, Cytokine, BSA, COVID-19, NRS, AD, SAN, Eosinophilic esophagitis, Allergic rhinitis, Forward-looking statement, Safety, Risk, Skin, Security (finance), Protein, Cancer, GLOBE, CCR4, Itch, Psoriasis Area and Severity Index, CEO, Atopic dermatitis, Tissue, Pharmaceutical industry, Vaccine, T helper cell, EASI

We are excited to advance RPT193 into this Phase 2b trial in atopic dermatitis, said Brian Wong, M.D., Ph.D., President and CEO of RAPT.

Key Points: 
  • We are excited to advance RPT193 into this Phase 2b trial in atopic dermatitis, said Brian Wong, M.D., Ph.D., President and CEO of RAPT.
  • In a post-hoc statistical analysis comparing RPT193-treated patients to placebo-treated patients, the improvements in EASI, EASI-50 and BSA at Day 43 were statistically significant.
  • The U.S. based Phase 2b trial is designed to assess the efficacy and safety of multiple-dose levels of RPT193 as monotherapy in patients with moderate-to-severe AD.
  • RPT193 is a small molecule oral therapy in development for the treatment of atopic dermatitis and other inflammatory diseases.

LEO Pharma Presents New Interim Long-Term Efficacy Data for Adbry™ (tralokinumab-ldrm) in Moderate-to-Severe Atopic Dermatitis at the 2022 RAD Conference

Retrieved on: 
Monday, April 11, 2022
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LEO Pharma A/S, a global leader in medical dermatology, today announced 3-year data that help provide insight into the long-term 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 3-year data that help provide insight into the long-term efficacy profile of Adbry (tralokinumab-ldrm) in adult patients with moderate-to-severe atopic dermatitis (AD).
  • It is encouraging to have more data available to inform those seeking a biologic option to help manage moderate-to-severe AD.
  • Comparable treatment responses were observed by modified non-responder imputation and last observation carried forward analyses, as reported at the RAD Conference.
  • The safety profile in this interim analysis was consistent with the safety profile observed in previous controlled studies with Adbry.

ASLAN Pharmaceuticals Announces Late-Breaker Presentation of Data From Eblasakimab Proof-of-Concept Study at the 2022 American Academy of Dermatology Annual Meeting

Retrieved on: 
Monday, March 28, 2022
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Its a heterogeneous disease and, hence, the need for novel, differentiated therapies remains great.

Key Points: 
  • Its a heterogeneous disease and, hence, the need for novel, differentiated therapies remains great.
  • Eblasakimab is a novel, potential first-in-class monoclonal antibody that targets the IL-13 receptor 1 subunit (IL-13R1), one of the components of the Type 2 receptor.
  • Based on a review of blinded safety data, the highest dose, 600mg, was selected for the expansion cohort, which recruited 27 additional patients.
  • The proportion of patients with adverse events and treatment-related adverse events were similar across treatment and placebo arms.

Evelo Biosciences Presents Late-Breaking Oral Abstract on Data from Phase 2 Trial of EDP1815 in Psoriasis at 2022 American Academy of Dermatology Annual Meeting

Retrieved on: 
Saturday, March 26, 2022
Inflammation, Medicare Part D coverage gap, AAD, American Academy of Dermatology, Pharmacology, Part, Probability, Psoriasis, Safety, GLOBE, American Academy, Physician, Infection, Psoriasis Area and Severity Index, KOL, Spectrochimica Acta Part B, Patient, Pharmaceutical industry, Medical imaging, Dermatology

We are proud to join the dermatology community at AAD to share the latest data from the clinical development of EDP1815 in psoriasis.

Key Points: 
  • We are proud to join the dermatology community at AAD to share the latest data from the clinical development of EDP1815 in psoriasis.
  • During the 16-week dosing period, the primary endpoint analysis demonstrated EDP1815 was superior to placebo with 80-90% probability across each cohort.
  • In Part B of the trial, patients were followed for up to 24 weeks after they had stopped receiving EDP1815 or placebo.
  • During the post-treatment period, durable and deepening clinical responses were observed, with no flare or rebound of psoriasis.

Dermavant Showcases New Long-Term Durability and Tolerability Data from Phase 3 PSOARING 3 Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022 AAD Annual Meeting

Retrieved on: 
Friday, March 25, 2022
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The durable improvements demonstrated by tapinarof in PSOARING 3 across efficacy outcomes, quality of life and tolerability scores are encouraging.

Key Points: 
  • The durable improvements demonstrated by tapinarof in PSOARING 3 across efficacy outcomes, quality of life and tolerability scores are encouraging.
  • As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.
  • Eligible patients who completed either PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

Evelo Biosciences Announces Fourth Quarter and Full Year 2021 Financial Results and Business Highlights

Retrieved on: 
Thursday, March 24, 2022
Inflammation, Company, Regulation, European Parliament, Marketing, Cytokine, European, European Medicines Agency, Medicare Part D coverage gap, PIP, Clinical trial, AAD, Adult, DLQI, American Association, Council, Psoriasis, Health, Psoriasis Area and Severity Index, PSI, EC, TNF, Jejunum, GLOBE, EMA, Dermatology Life Quality Index, IL-6, Maintenance, KOL, Proceedings of the Institution of Mechanical Engineers, Part B, Patient, Disease, Volunteering, Pharmaceutical industry, Dietary supplement, Part, Dermatology

CAMBRIDGE, Mass., March 24, 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 reported financial results and business highlights for the fourth quarter and full year 2021.

Key Points: 
  • ET
    CAMBRIDGE, Mass., March 24, 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 reported financial results and business highlights for the fourth quarter and full year 2021.
  • The primary unmet need in psoriasis is for this segment of patients, said Simba Gill, Ph.D., Chief Executive Officer of Evelo.
  • An ad hoc analysis comparing the combined EDP1815 group also showed a statistically significant improvement over placebo in rates of PASI-50 response.
  • ET today to review fourth quarter and full year 2021 highlights.

Dermavant Showcases New Long-Term Durability and Tolerability Data from Phase 3 PSOARING 3 Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022 AAD Annual Meeting

Retrieved on: 
Friday, March 25, 2022
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As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.

Key Points: 
  • As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.
  • Eligible patients who completed either PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3.
  • Patients who were randomized to tapinarof in PSOARING 1 or 2 and who also completed PSOARING 3 received tapinarof treatment for up to 52 weeks.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.