Atopic Dermatitis - Pipeline Insight, 2021

May 2021 | 120 pages | ID: A80C2107FA09EN
DelveInsight

Abstracts

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DelveInsight’s, “Atopic Dermatitis – Pipeline Insight, 2021,” report provides comprehensive insights about 100+ companies and 100+ pipeline drugs in Atopic Dermatitis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Atopic Dermatitis Understanding

Atopic Dermatitis: Overview

Atopic dermatitis (AD) also called eczema, is a chronic condition and the most common type of skin inflammation that usually starts in early childhood, but can occur at any age and can be recurrent or persistent throughout life. In the word ‘dermatitis,’ ‘derm’ means ‘skin’ and ‘itis’ means ‘inflammation.’ Thus, dermatitis is a skin inflammation characterized by itchiness, redness and a rash caused by genetics, an overactive immune system, infections, allergies, and irritating substances. Half of the patients with moderate-to-severe eczema also have asthma, hay fever (allergic rhinitis), and food allergies. It is the most common chronic skin disease in children. The primary symptom of AD is dry, itchy skin that often turns into a red rash. During a flare, AD becomes a red, itchy rash. Many different physical and internal factors can trigger an eczema flare-up. The exact cause of AD is unknown. The basic understanding of AD is that inflammation results from the presence of too many inflammatory cells in the skin. There is also evidence that people with AD have a compromised skin barrier compared to normal skin. Currently, there is no specific test for AD, and no single symptom or feature can be used to identify the disease. Each patient has a unique combination of symptoms and rash appearance. Diagnosis of AD is based on the history and physical examination of the patient. In uncertain cases, a skin biopsy may be taken for a histopathological diagnosis of dermatitis. Currently, there is no cure for AD; however, it can be effectively managed with current treatment options.

'Atopic Dermatitis - Pipeline Insight, 2021' report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Atopic Dermatitis pipeline landscape is provided which includes the disease overview and Atopic Dermatitis treatment guidelines. The assessment part of the report embraces, in depth Atopic Dermatitis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Atopic Dermatitis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Atopic Dermatitis R&D. The therapies under development are focused on novel approaches to treat/improve Atopic Dermatitis.

Atopic Dermatitis Emerging Drugs Chapters

This segment of the Atopic Dermatitis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Atopic Dermatitis Emerging Drugs

• Abrocitinib: Pfizer

Abrocitinib (PF-04965842) is an oral, small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 modulates multiple cytokines involved in the pathophysiology of AD, including interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP). The drug received breakthrough therapy designation from the FDA to treat patients with moderate-to-severe AD in February 2018. In October 2020, based on the results of a robust Phase III clinical trial program, the FDA, accepted the filing of the company’s NDA for abrocitinib (100 mg and 200 mg) and granted priority review designation; the decision is anticipated April 2021. EMA accepted the MAA for the drug in the same patient population with a decision anticipated in the second half of 2021.

• Upadacitinib: AbbVie

Upadacitinib (ABT-494) was discovered and developed by AbbVie. It is a selective and reversible JAK inhibitor that was approved by FDA and EMA in August 2019 and December 2019, respectively, for adult patients with moderately to severely active rheumatoid arthritis. The drug is currently under clinical developmental studies for atopic dermatitis, and several other immune-mediated diseases. %li%In October 2020, AbbVie submitted an application to the FDA and EMA seeking approval for Rinvoq for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate-to-severe AD. The atopic dermatitis indication applications to the FDA and EMA are supported by data from three pivotal Phase 3 studies.

• Tradipitant: Vanda Pharmaceuticals

Tradipitant is a small molecule based neurokinin 1 (NK1) receptor antagonist. Tradipitant is currently in phase III clinical development for gastroparesis, COVID-19 pneumonia, motion sickness and atopic dermatitis. Tradipitant licensed by Vanda from Eli Lilly and Company (Lilly) in April 2012. The patent describing tradipitant as a new chemical entity expires worldwide in April 2023, except in the United States, where it expires in June 2024.

• Nemolizumab: Galderma

Nemolizumab (CD14152) is a subcutaneously administered monoclonal antibody that antagonizes IL-31RA, a cytokine that plays a key role in the pathogenesis of moderate-to-severe AD, thereby blocking IL-31 signaling on its effector cells, including peripheral neurons. The drug was initially developed by Chugai Pharmaceutical and subsequently licensed to Galderma in 2016. Currently, the drug is being studied in Phase III trial as a once-daily oral therapy for moderate-to-severe AD in adults and in several other immune-mediated diseases.

• Lebrikizumab: Eli Lilly and Company

Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13R?1/IL-4R? heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening, and infection. The drug is being evaluated in Phase III stage of development for the treatment of patients with Atopic dermatitis.

• IDP 124: Ortho Dermatologics

Bausch Health Americas in collaboration with Ortho Dermatologics is developing IDP 124 for the treatment of patients with Atopic dermatitis. The drug is currently in phase 3 of clinical trials.

• SHR0302: Reistone Biopharma

SHR0302 is a highly selective small molecule based JAK 1 inhibitor. Reistone licensed in the drug from Jiangsu Hengrui Medicine and owns the global rights for multiple indications of autoimmune diseases. Reistone Biopharma is developing SHR0302 in linical studies with both oral and topical dosage forms for several immune-inflammatory diseases including Ulcerative Colitis, Crohn's disease, etc. The high selectivity of SHR0302 may potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitors.

• MEDI3506: AstraZeneca

MEDI 3506 is an IL-33 (interleukin-33) monoclonal antibody being developed by AstraZeneca for the treatment of Atopic Dermatitis and chronic diabetic kidney disease. The drug is currently being studied in phase II stage of development for the treatment of patients with Atopic Dermatitis.

Further product details are provided in the repor

Atopic Dermatitis: Therapeutic Assessment

This segment of the report provides insights about the different Atopic Dermatitis drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Atopic Dermatitis

There are approx. 100+ key companies which are developing the therapies for Atopic Dermatitis. The companies which have their Atopic Dermatitis drug candidates in the most advanced stage, i.e. Phase III include, Lysogene.

• Phases

DelveInsight’s report covers around 100+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Atopic Dermatitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Atopic Dermatitis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Atopic Dermatitis therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Atopic Dermatitis drugs.

Atopic Dermatitis Report Insights

• Atopic Dermatitis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Atopic Dermatitis Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Atopic Dermatitis drugs?
• How many Atopic Dermatitis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Atopic Dermatitis?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Atopic Dermatitis therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Atopic Dermatitis and their status?
• What are the key designations that have been granted to the emerging drugs?

Contents

Introduction
Executive Summary
Atopic Dermatitis: Overview
  Causes
  Mechanism of Action
  Signs and Symptoms
  Diagnosis
  Disease Management
Pipeline Therapeutics
  Comparative Analysis
Therapeutic Assessment
  Assessment by Product Type
  Assessment by Stage and Product Type
  Assessment by Route of Administration
  Assessment by Stage and Route of Administration
  Assessment by Molecule Type
  Assessment by Stage and Molecule Type
Atopic Dermatitis – DelveInsight’s Analytical Perspective
In-depth Commercial Assessment
  Atopic Dermatitis companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Atopic Dermatitis Collaboration Deals
  Company-Company Collaborations (Licensing / Partnering) Analysis
  Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Registered)
  Comparative Analysis
Abrocitinib: Pfizer
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
  Comparative Analysis
MEDI3506: AstraZeneca
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Early stage products (Phase I/II)
  Comparative Analysis
UCB9741: UCB Biopharma
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Preclinical stage products
  Comparative Analysis
PBI-100: Pyramid Bioscience
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
  Comparative Analysis
Atopic Dermatitis Key Companies
Atopic Dermatitis Key Products
Atopic Dermatitis- Unmet Needs
Atopic Dermatitis- Market Drivers and Barriers
Atopic Dermatitis- Future Perspectives and Conclusion
Atopic Dermatitis Analyst Views
Atopic Dermatitis Key Companies
Appendix

List Of Tables

LIST OF TABLES

Table 1 Total Products for Atopic Dermatitis
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products

List Of Figures

LIST OF FIGURES

Figure 1 Total Products for Atopic Dermatitis
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products