Psoriasis Area and Severity Index

MoonLake Immunotherapeutics screens first patient in Phase 2 study of the Nanobody® sonelokimab in active psoriatic arthritis

Retrieved on: 
Wednesday, December 14, 2022
Inflammatory arthritis, MIRA, PASI, Veni, vidi, vici, Security (finance), Psoriatic arthritis, Adalimumab, Fatigue, Health assessment, Severity, Ageing, Research, ACR, Psoriasis Area and Severity Index, American College of Rheumatology, Inflammation, American College, Safety, Skin, Pain, Chemokine, Disability, Psoriasis, Moonlake, Securities and Exchange Commission (Philippines), Quality of life, VHH, Temperature, Trial of the century, Joint, KDA, Disease, Tissue, Patient, Swelling, Single-domain antibody, Antibody, ARGO, Hidradenitis suppurativa, Pharmaceutical industry, Vaccine, Oyster, Medical imaging, Sanofi, Ablynx

Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented: “We are very pleased to have begun the ARGO study of the Nanobody sonelokimab in the treatment of psoriatic arthritis.

Key Points: 
  • Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented: “We are very pleased to have begun the ARGO study of the Nanobody sonelokimab in the treatment of 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.
  • Sonelokimab has been assessed in a randomized, placebo-controlled Phase 2b study in 313 patients with moderate-to-severe plaque-type psoriasis.
  • Psoriatic arthritis (PsA) is a chronic and progressive inflammatory arthritis associated with psoriasis primarily affecting the peripheral joints.

Takeda to Acquire Nimbus Therapeutics’ Highly Selective, Allosteric TYK2 Inhibitor to Address Multiple Immune-Mediated Diseases

Retrieved on: 
Tuesday, December 13, 2022
Health, Infectious Diseases, Technology, Other Technology, Clinical Trials, Pharmaceutical, Biotechnology, Therapy, TYK2, Psoriasis, HSR, HPK1, Patient, Cancer, TAK, Psoriasis Area and Severity Index, Research, Hart–Scott–Rodino Antitrust Improvements Act, MBA, Acquisition, Pharmaceutical industry, Nimbus, Takeda

Nimbus Therapeutics , LLC (Nimbus Therapeutics or Nimbus), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced that it has signed a definitive agreement under which Takeda (TSE:4502/NYSE:TAK) will acquire Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858.

Key Points: 
  • Nimbus Therapeutics , LLC (Nimbus Therapeutics or Nimbus), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced that it has signed a definitive agreement under which Takeda (TSE:4502/NYSE:TAK) will acquire Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858.
  • NDI-034858 is an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis.
  • Under the terms of the agreement, Takeda will pay Nimbus Therapeutics $4 billion upfront, and sales-based milestone payments up to $2 billion.
  • NDI-034858 is an allosteric TYK2 inhibitor discovered and developed by Nimbus Therapeutics that is being evaluated for the treatment of multiple autoimmune diseases.

Ventyx Biosciences Announces Dosing of the First Patient in the Phase 2 SERENITY Trial of VTX958 for the Treatment of Moderate to Severe Plaque Psoriasis

Retrieved on: 
Thursday, December 1, 2022
COVID-19, Securities and Exchange Commission (Philippines), TYK2, Inflammation, Patient, NLRP3, Cytokine, Psoriasis Area and Severity Index, Security (finance), Risk, Research, Psoriasis, Animal, Safety, Pharmaceutical industry, Part Two

ENCINITAS, Calif., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a range of inflammatory diseases with significant unmet medical need, today announced that the first patient has been dosed in a Phase 2 trial of its selective, allosteric TYK2 inhibitor VTX958 for the treatment of moderate to severe plaque psoriasis.

Key Points: 
  • Topline data from the Phase 2 SERENITY trial are expected in the fourth quarter of 2023.
  • The Phase 2 SERENITY trial is a randomized, double-blind, placebo-controlled, dose-ranging trial to evaluate the safety and efficacy of VTX958 in patients with moderate to severe plaque psoriasis.
  • The trial will enroll approximately 200 patients randomized to one of four VTX958 doses or placebo for a 16-week double-blind treatment period.
  • Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements.

Nimbus Therapeutics Announces Positive Topline Results for Phase 2b Clinical Trial of Allosteric TYK2 Inhibitor in Psoriasis

Retrieved on: 
Wednesday, November 30, 2022
Research, Clinical Trials, Biotechnology, Other Health, Managed Care, Health, Pharmaceutical, Other Science, Science, Autoimmune disease, Drug, TYK2, University, Safety, Therapy, Lupus, Nimbus, Patient, IBD, Psoriasis Area and Severity Index, Dean (education), HPK1, Cancer, Psoriasis, MPH, Inflammatory bowel disease, Pharmaceutical industry, Dermatology

Nimbus Therapeutics , a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced positive topline results from a Phase 2b clinical trial evaluating the allosteric TYK2 inhibitor NDI-034858 in patients with moderate-to-severe plaque psoriasis.

Key Points: 
  • Nimbus Therapeutics , a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced positive topline results from a Phase 2b clinical trial evaluating the allosteric TYK2 inhibitor NDI-034858 in patients with moderate-to-severe plaque psoriasis.
  • We are pleased to report success from our Phase 2b psoriasis patient trial that supports NDI-034858s best-in-class potential among the new class of allosteric TYK2 inhibitors.
  • NDI-034858 is an allosteric TYK2 inhibitor developed by Nimbus Therapeutics that is being evaluated for the treatment of multiple autoimmune diseases.
  • In addition to psoriasis, Nimbus is evaluating NDI-034858 in an ongoing Phase 2b trial in active psoriatic arthritis ( NCT05153148 ).

Evelo Biosciences Reports Third Quarter 2022 Financial Results and Business Highlights

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Monday, November 14, 2022
Marketing, TH1, RNA-Seq, Inflammation, Chemistry, EV, Seminal vesicles, Research, Chorionic gonadotropin beta, Risk, Inflammatory bowel disease, European Medicines Agency, IL-6, Allergy, TNF, Conference, Patient, IL-8, Arthritis, Cytokine, European Academy of Allergy and Clinical Immunology, CTA, T helper 17 cell, Development, FDA, COVID-19, Growth, Health care, EMA, Physician, Disease, Volunteering, Failure, Clinical trial, Atopic dermatitis, EVS, CMC, Administration, Poster, PASI, Psoriasis Area and Severity Index, Blood, Asthma, MHRA, Confidentiality, Congress, Pharmaceutical industry, Medical device, Dietary supplement, Dermatology, Venereology, Psoriasis

CAMBRIDGE, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, today announced its third quarter 2022 financial results and business highlights.

Key Points: 
  • Recruitment for the first three cohorts in the Phase 2 trial of EDP1815 in atopic dermatitis is complete.
  • Recruitment for the fourth cohort is ahead of schedule, with data expected in the second quarter of 2023.
  • In September 2022, Evelo presented a poster at the 2022 European Academy of Dermatology and Venereology (EADV) Congress.
  • In October 2022, Evelo presented two posters at the 2022 Fall Clinical Dermatology Conference.

MoonLake Immunotherapeutics Reports Third Quarter 2022 Financial Results and Provides Recent Business Update

Retrieved on: 
Monday, November 14, 2022
Dermatology Life Quality Index, Clinical trial, MIRA, Abscess, Safety, Dermatology, Disease, Severity, Chemokine, Antibody, Prevalence, Investment, Health assessment, Moonlake, American College, Research, Inflammation, Pain, Adalimumab, Psoriasis Area and Severity Index, VHH, Patient, FDA, Rheumatology, Psoriasis, KDA, SLK, ARGO, Veni, vidi, vici, Skin, IRB, American College of Rheumatology, Temperature, Bimekizumab, Tissue, ACR, Numerical, Secukinumab, Pharmaceutical industry, Oyster, Medical imaging, Video game, HS, Ablynx, Psoriatic arthritis, Sanofi

Research and development expenses for the quarter ended September30, 2022, were $9.0 million, as compared to $11.4 million in the previous quarter.

Key Points: 
  • Research and development expenses for the quarter ended September30, 2022, were $9.0 million, as compared to $11.4 million in the previous quarter.
  • General and administrative expenses for the quarter ended September30, 2022, were $5.7 million, as compared to $6.3 million in the previous quarter.
  • Net loss for the quarter ended September30, 2022, was $14.7 million, compared to $17.4 million in the previous quarter.
  • MoonLake Immunotherapeutics AG, subsidiary of MoonLake Immunotherapeutics, was founded in 2021 and is headquartered in Zug, Switzerland.

DICE Therapeutics Reports Third Quarter 2022 Financial Results and Recent Highlights

Retrieved on: 
Wednesday, November 9, 2022
GLOBE, PPI, Private Securities Litigation Reform Act, Idiopathic pulmonary fibrosis, Forward-looking statement, IND, Psoriasis, Serum, Food, Nasdaq, Psoriasis Area and Severity Index, Research, Conditional sentence, Keratinocyte, Tissue, National Psoriasis Foundation, Association, Inflammatory bowel disease, COVID-19, Bleeding, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Doctor of Philosophy, PASI, Degenerative disease, Goal, DICE, Safety, Epithelium, Autoimmunity, IL-17, Company, Biomarker, Inflammation, Disease, D, Patient, Immune system, Pain, CEO, Infection, Fibroblast, FDA, Pharmaceutical industry, Vaccine

DC-806 was well tolerated with an excellent safety profile across all dose groups in healthy volunteers and psoriasis patients.

Key Points: 
  • DC-806 was well tolerated with an excellent safety profile across all dose groups in healthy volunteers and psoriasis patients.
  • In addition, in October 2022, DICE announced the successful closing of an upsized public offering, raising gross proceeds of $345.0 million.
  • R&D Expenses: Research and development expenses were $14.7 million for the third quarter of 2022, compared to $11.7 million for the same period in 2021.
  • G&A Expenses: General and administrative expenses were $6.4 million for the third quarter of 2022, compared to $4.4 million for the same period in 2021.

Can-Fite: Positive New Data from it’s Phase III Psoriasis Study will be Presented Today at an Industry Expert Summit in Boston

Retrieved on: 
Wednesday, November 2, 2022
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Diabetes, Clinical Trials, PASI, Dermatology, Fatty liver disease, Psoriasis Area and Severity Index, CANF, Apoptosis, Liver, Treatment, SEC, Skin condition, Cancer, HCC, NYSE, Industry, COVID-19, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PGA, Safety, Drug, Liver cancer, NASH, Technology, TASE, Hepatocellular carcinoma, Colon, Melanoma, Company, Review, Communication, Patient, Drug development, Food, Prostate, Inflammation, Erectile dysfunction, Summit, Erythema, Forward-looking statement, Keratinocyte, NYSE American, Institute of Liver and Biliary Sciences, Pharmaceutical industry, Psoriasis

COMFORT, a Phase III, multicenter, randomized, placebo- and active-controlled, double-blind study assessed the efficacy and safety of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis.

Key Points: 
  • COMFORT, a Phase III, multicenter, randomized, placebo- and active-controlled, double-blind study assessed the efficacy and safety of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis.
  • The study further showed that in patients with severe disease, Piclidenosons efficacy is similar to Otezla, currently the top selling oral psoriasis drug.
  • Piclidenosons safety profile in the study was similar to placebo and it was better tolerated than Otezla.
  • The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis.

Almirall announces EMA acceptance for filing of Marketing Authorization Application (MAA) for lebrikizumab in atopic dermatitis

Retrieved on: 
Friday, October 28, 2022
Skin, Phase, MAA, Atopic dermatitis, Company, Dermatology, AD, Marketing, Prevalence, Safety, Adherence, Advocate, Eli Lilly and Company, File, Patient, Almirall, Adult, Adolescence, Week, TCS, Eczema Area and Severity Index, EudraCT, Psoriasis Area and Severity Index, EMA, ALM, Vaccine, Pharmaceutical industry, EU

"Today marks the first step of the regulatory process in Europe of lebrikizumab, which we believe it has the potential to become a best-in-class treatment for atopic dermatitis.

Key Points: 
  • "Today marks the first step of the regulatory process in Europe of lebrikizumab, which we believe it has the potential to become a best-in-class treatment for atopic dermatitis.
  • Upon approvalby the EMA, patients with AD would have a new treatment option with a favourable safety and efficacy profile.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.
  • [*] More information about the Phase III studies: ADvocate 1: EudraCT Number 2019-002932-10; NCT04146363; ADvocate 2: EudraCT Number 2019-002933-12; NCT04178967; Adhere: EudraCT Number 2019-004300-34; NCT04250337

EQS-News: Immunic Reports Pre-Planned Phase 1b Interim Analysis of IMU-935 in Psoriasis Patients Confounded by High Placebo Rate

Retrieved on: 
Saturday, October 22, 2022
Psoriasis, U.S. Securities and Exchange Commission, SEC, Multiple sclerosis, Cytokine, Degenerative disease, Part, Antibody, Patient, Drug development, Primary sclerosing cholangitis, Security (finance), Nasdaq, Private Securities Litigation Reform Act, NEW, Serum, Psoriasis Area and Severity Index, PBMC, DHODH, Graft-versus-host disease, Nature, Safety, Clinical trial, Public expenditure, Inflammatory bowel disease, Metabolism, COVID-19, Human, Pharmaceutical industry, Vaccine, T helper 17 cell, Short course immune induction therapy

The pre-planned interim analysis revealed that the group averages for Psoriasis Area and Severity Index (PASI) reductions in the two active arms did not separate from placebo at four weeks.

Key Points: 
  • The pre-planned interim analysis revealed that the group averages for Psoriasis Area and Severity Index (PASI) reductions in the two active arms did not separate from placebo at four weeks.
  • The primary objective was the evaluation of the safety and tolerability of IMU-935 in moderate-to-severe psoriasis patients.
  • The interim analysis only revealed mean values at group-level up to the end of the four-week treatment period.
  • The unexpected high placebo rates observed in this interim analysis are disappointing and confound the evaluation of activity in the investigated active treatment arms.