Warm Autoimmune Hemolytic Anemia Waiha Pipeline Insight

DelveInsight’s, “Warm Autoimmune Hemolytic Anemia (WAIHA) – Pipeline Insight, 2020,” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Warm Autoimmune Hemolytic Anemia 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

Warm Autoimmune Hemolytic Anemia Understanding

Warm Autoimmune Hemolytic Anemia (WAIHA): Overview

Warm antibody hemolytic anemia is an autoimmune disorder characterized by the premature destruction of healthy red blood cells by autoantibodies. Autoimmune diseases occur when the body's natural defenses against foreign organisms (e.g., lymphocytes, antibodies) destroy healthy tissue for unknown reasons. Normally, red blood cells have a life span of approximately 120 days before they are removed by the spleen. The medical term for low levels of circulating red blood cells is anemia. Anemia may cause fatigue, a pale skin color (pallor), yellowing of the skin and whites of the eyes (jaundice) and the passage of blood in the urine (hemoglobinuria), which gives the urine a dark brown color. Warm antibody hemolytic anemia is classified as an autoimmune hemolytic anemia (AIHA), an uncommon group of disorders in which the immune system mistakenly attacks healthy red blood cells.

Symptoms

The symptoms of warm antibody hemolytic anemia usually develop slowly over a period of several weeks to months, but in some cases can develop suddenly over a few days. Specific symptoms that occur may vary from one person to another and may depend upon the rate of onset, the rate of destruction of healthy red blood cells and the presence of an underlying disorder. Some individuals, especially those with a gradual onset of anemia, may not have any obvious symptoms (asymptomatic). Affected individuals may eventually develop abnormal paleness of the skin (pallor), fatigue, difficulty breathing upon exertion, dizziness and palpitations. Yellowing of the skin and whites of the eyes (jaundice) and enlargement of the spleen (splenomegaly) are also common findings in individuals with warm antibody hemolytic anemia. Splenomegaly may cause an affected individual to have a bloated or full feeling in the abdomen. Occasionally enlargement of the liver (hepatomegaly) may also occur in some people.

Diagnosis

A diagnosis of hemolytic anemia may be suspected based upon a thorough clinical evaluation, a detailed patient history, identification of characteristic symptoms and a variety of tests such as blood tests that measure hemoglobin and hematocrit. When anemia is suspected to be caused by immune system dysfunction (autoimmune hemolytic anemia), specialized tests such as a Coombs test may be performed. This test is used to detect antibodies that act against red blood cells. A sample of blood is taken and then exposed to the Coombs reagent. A positive test is indicated when the red blood cells clump in the presence of the reagent.

Treatment

The treatment of warm antibody hemolytic anemia is symptomatic and supportive. Affected individuals are usually treated with corticosteroid drugs such as prednisone and can usually be well controlled with proper treatment. A high-dose of these drugs may be initially recommended followed by a gradual reduction (tapering) of the dose over the next few weeks or months. For individuals who do not respond to corticosteroid therapy or develop intolerable side effects, immunosuppressive drugs may be administered or surgical removal of the spleen (splenectomy) may be performed. Rituximab is a monoclonal antibody, an artificially-created antibody that targets certain white blood cells that create the antibodies which prematurely destroy red blood cells.

Warm Autoimmune Hemolytic Anemia Emerging Drugs Chapters

This segment of the Warm Autoimmune Hemolytic Anemia 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.

Warm Autoimmune Hemolytic Anemia Emerging Drugs

  • Fostamatinib: Rigel Pharmaceuticals

Rigel Pharmaceuticals is conducting a phase 2, multi-center, open label, simon two-stage study to evaluate the safety and efficacy of fostamatinib disodium in the treatment of Warm Antibody Autoimmune Hemolytic Anemia. The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).


  • BIV009: Bioverativ, a Sanofi company

Sanofi is conducting a prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in patients with a complement-mediated disorder, and Part E, a multiple dose (MD) study in patients with cold agglutinin disease previously treated with BIVV009 within the scope of a BIVV009 clinical trial or named patient program use. Note: For parts A-C as well as at the start of part E, study drug was named TNT009. The study drug name is changed to BIVV009 with final version Final 15.0 of the clinical study protocol.

Further product details are provided in the report……..

Warm Autoimmune Hemolytic Anemia: Therapeutic Assessment

This segment of the report provides insights about the different Warm Autoimmune Hemolytic Anemia drugs segregated based on following parameters that define the scope of the report, such as:


  • Major Players in Warm Autoimmune Hemolytic Anemia

There are approx. 5+ key companies which are developing the therapies for Warm Autoimmune Hemolytic Anemia. The companies which have their Warm Autoimmune Hemolytic Anemia drug candidates in the mid to advanced stage, i.e. phase III and Phase II include, Rigel Pharmaceuticals, Immunovant Sciences GmbH, Apellis Pharmaceuticals, Inc. etc.

  • Phases


DelveInsight’s report covers around 5+ products under different phases of clinical development like

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


Warm Autoimmune Hemolytic Anemia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Subcutaneous
  • Oral
  • Intramuscular
  • Intravenous
  • Molecule Type


Products have been categorized under various Molecule types such as

  • Small molecules
  • Polyethylene glycols
  • Cyclic peptides
  • Monoclonal antibodies
  • Immunotherapies
  • Product Type

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

Warm Autoimmune Hemolytic Anemia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Warm Autoimmune Hemolytic Anemia 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 Warm Autoimmune Hemolytic Anemia drugs.

Report Highlights

  • The companies and academics are working to assess challenges and seek opportunities that could influence Warm Autoimmune Hemolytic Anemia R&D. The therapies under development are focused on novel approaches to treat/improve Warm Autoimmune Hemolytic Anemia.
  • ANX005, a clinical-stage investigational monoclonal antibody intended to treat patients with complement-mediated disorders, is currently being evaluated to treat Guillain-Barre Syndrome (GBS), warm autoimmune hemolytic anemia (wAIHA), Huntington’s disease (HD) and ALS. Phase 2a trials in patients with HD and ALS and a Phase 2 trial in patients with wAIHA are planned for 2H 2020. A Phase 2/3 trial in patients with GBS is expected to begin in early 2021.

Warm Autoimmune Hemolytic Anemia Report Insights

  • Warm Autoimmune Hemolytic Anemia Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Warm Autoimmune Hemolytic Anemia 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 Warm Autoimmune Hemolytic Anemia drugs?
  • How many Warm Autoimmune Hemolytic Anemia drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Warm Autoimmune Hemolytic Anemia?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Warm Autoimmune Hemolytic Anemia 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 Warm Autoimmune Hemolytic Anemia and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • Fostamatinib
  • Immunovant Sciences GmbH
  • Apellis Pharmaceuticals, Inc.
  • Bioverativ

 Key Products

  • Fostamatinib
  • RVT-1401 680
  • APL-2
  • BIV009

 

Introduction

Executive Summary

Warm Autoimmune Hemolytic Anemia: 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

Warm Autoimmune Hemolytic Anemia – DelveInsight’s Analytical Perspective

In-depth Commercial Assessment

• Warm Autoimmune Hemolytic Anemia companies’ collaborations, Licensing, Acquisition -Deal Value Trends

Warm Autoimmune Hemolytic Anemia Collaboration Deals

• Company-Company Collaborations (Licensing / Partnering) Analysis

• Company-University Collaborations (Licensing / Partnering) Analysis

Late Stage Products (Phase III)

• Comparative Analysis

Fostamatinib: Rigel Pharmaceuticals

• Product Description

• Research and Development

• Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

• Comparative Analysis

APL-2: Apellis Pharmaceuticals, Inc.

• Product Description

• Research and Development

• Product Development Activities

Early Stage Products (Phase II)

BIV009: Bioverativ

• Product Description

• Research and Development

• Product Development Activities

Drug profiles in the detailed report…..

Pre-clinical and Discovery Stage Products

• Comparative Analysis

• Product Description

• Research and Development

• Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

• Comparative Analysis

Warm Autoimmune Hemolytic Anemia Key Companies

Warm Autoimmune Hemolytic Anemia Key Products

Warm Autoimmune Hemolytic Anemia- Unmet Needs

Warm Autoimmune Hemolytic Anemia- Market Drivers and Barriers

Warm Autoimmune Hemolytic Anemia- Future Perspectives and Conclusion

Warm Autoimmune Hemolytic Anemia Analyst Views

Warm Autoimmune Hemolytic Anemia Key Companies

Appendix

List of Tables

 Table 1 Total Products for Warm Autoimmune Hemolytic Anemia

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

 Figure 1 Total Products for Warm Autoimmune Hemolytic Anemia

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

• Fostamatinib

• Immunovant Sciences GmbH

• Apellis Pharmaceuticals, Inc.

• Bioverativ

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