DelveInsight’s, “Chronic Spontaneous Urticaria – Pipeline Insight, 2020,” report provides comprehensive insights about 20+ companies and 20+ pipeline drugs in Chronic Spontaneous Urticaria 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
Chronic Spontaneous Urticaria Understanding
Chronic Spontaneous Urticaria: Overview
Urticaria (also called hives, wheals, or nettle rash) is characterized by pruritic, erythematous, and edematous wheals. The hallmark of urticaria is that individual lesions wax and wane rapidly, usually lasting less than 4 hours. In clinical practice, it is important to ascertain whether lesions last less or more than 24 hours as this increases the likelihood of urticarial vasculitis. Urticaria can be classified as acute or chronic. Chronic spontaneous urticaria refers to chronic urticaria that has no specific cause or trigger. Weals are present on most days of the week for 6 weeks or more. Chronic spontaneous urticaria was previously referred to as chronic idiopathic urticaria. This term is no longer used as many cases have an autoimmune basis.
Symptoms
Chronic spontaneous urticaria is characterized by the presence of weals and angioedema. Weals can affect any site on the body and tend to be distributed widely.
• Weals can be a few millimeters or several centimeters in diameter.
• They can be colored white or red, usually with a red flare.
• Each weal may last a few minutes or several hours, and they may change shape before resolving.
• Weals may be round or form rings, a map-like pattern, or giant patches.
Diagnosis
Chronic urticaria is diagnosed through the taking of a careful history and examination; this diagnosis is based on a history lasting over 6 weeks of daily or episodic weals that last less than 24 hours without the presence of physical trigger factors. The international guidelines recommend limiting investigations in most patients with chronic spontaneous urticaria to differential blood count and erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Further diagnostic measures are based on patient history and examination, especially in patients with long-standing and uncontrolled disease.
Treatment
There is no ‘cure’ for chronic urticaria. The goal of treatment is to achieve symptom-free control.
The approach to the management of chronic spontaneous urticaria can involve:
• Identification and elimination of any underlying causes
• Avoidance of any known aggravating factors, such as NSAIDs
• Pharmacological treatment to prevent mast cell mediator release, or to prevent the effects of mast cell mediators.
Chronic Spontaneous Urticaria Emerging Drugs Chapters
This segment of the Chronic Spontaneous Urticaria 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.
Chronic Spontaneous Urticaria Emerging Drugs
• CT-P39: Celltrion
CT-P39, a biosimilar of omalizumab (Xolair) is a humanised anti-immunoglobulin E monoclonal antibody. The drug is being developed by Celltrion, In July 2019, Celltrion announced that it is planning to launch first clinical trial of CT-P39. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.
• Ligelizumab: Novartis
Ligelizumab is a next-generation high-affinity humanized monoclonal anti-IgE antibody designed for the treatment of severe asthma and chronic spontaneous urticaria. It binds to IGHE an acts as an immunomodulator. This drug was developed by Novartis Pharma AG. Research funded by Novartis Pharma after several clinical trials results the company concluded that Ligelizumab was more effective in treating chronic spontaneous urticaria than omalizumab. The drug is currently in phase III stage of development for the treatment of CIU.
• AZD-1981: AstraZeneca
AZD-1981, developed by AstraZeneca, is a potent (binding IC50 of 4nM), fully reversible, functionally non-competitive antagonist of human CRTh2. It blocks agonist-induced human eosinophil CD11b expression, shape change (including in whole blood), and chemotaxis as well as a basophil shape change and Th2-cell chemotaxis at IC50's of 8.5-50nM. Potency is similar across species as is plasma protein binding (~97%). AZD-1981 is a weak (10s of μM) inhibitor in vitro of CYP2C9, OATP1B1 and UGT1A1 as well as an inducer of CYP3A4. AZD-1981 was well tolerated and no safety concerns were identified. AstraZeneca is collaborating with Johns Hopkins University for the development of AZD-1981 in the treatment of chronic idiopathic urticaria. It is in phase II clinical studies for the treatment of Urticaria.
Further product details are provided in the report……..
Chronic Spontaneous Urticaria: Therapeutic Assessment
This segment of the report provides insights about the different Chronic Spontaneous Urticaria drugs segregated based on following parameters that define the scope of the report, such as:
• Major Players in Chronic Spontaneous Urticaria
There are approx. 20+ key companies which are developing the therapies for Chronic Spontaneous Urticaria. The companies which have their Chronic Spontaneous Urticaria drug candidates in the most advanced stage, i.e. phase III include, Celltrion.
• Phases
DelveInsight’s report covers around 20+ 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
Chronic Spontaneous Urticaria 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
• intravitreal
• Subretinal
• 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.

Chronic Spontaneous Urticaria: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chronic Spontaneous Urticaria 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 Chronic Spontaneous Urticaria drugs.

Report Highlights
• The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Spontaneous Urticaria R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Spontaneous Urticaria.
• The 3C technology platform is a high productivity, flexible, small footprint (50m2) manufacturing platform capable of making 1kg of drug substance antibody per week at a 50L bioreactor scale. Batch processing is made continuous with multicycle counter current operation. The upstream process is based on High Cell Density continuous perfusion culturing with alternating bioreactor use and the downstream process is based on Simulated Moving Bed chromatography combined with flow through filtration. The process has GMP status and is designed to run for up to 2 months. All steps run in parallel while interconnected via smart software (21 CFR part II) for flow control and data acquisition (currently being implemented).
• Yuhan Corp. announced it has licensed GI Innovation’s next-generation allergy treatment pipeline in a deal that could potentially total $1.2 billion. Under the deal, Yuhan has global rights, excluding Japan, to develop and commercialize GI-301. GI Innovation will collaborate on the development.
• In 2015, Regeneron Pharmaceuticals announced it had inked a global collaboration agreement with Paris-based Sanofi to develop several novel therapeutic candidates.
Chronic Spontaneous Urticaria Report Insights
• Chronic Spontaneous Urticaria Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs
Chronic Spontaneous Urticaria 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 Chronic Spontaneous Urticaria drugs?
• How many Chronic Spontaneous Urticaria drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Spontaneous Urticaria?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Chronic Spontaneous Urticaria 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 Chronic Spontaneous Urticaria and their status?
• What are the key designations that have been granted to the emerging drugs?
Key Players
• Allakos
• AstraZeneca
• Biosana
• Celldex Therapeutics
• Celltrion
• Eli Lilly and Company
• Genentech
• GI Innovation/Yuhan
• GlaxoSmithKline
• Glenmark Pharmaceuticals
• Gossamer Bio
• Kiniksa Pharmaceuticals
• Mycenax Biotech
• Novartis
• Regeneron
• Synermore Biologics
• UCB Biopharma
• United BioPharma

Key Products
• CT-P39
• Ligelizumab
• Antolimab
• Dupilumab
• LY3454738
• Fenebrutinib
• GB 001
• CDX-0159
• BP001
• Omalizumab biosimilar
• AZD1981
• KPL-716
• LOU064
• GSK2646264
• UB-221
• UCB8600
• Nucala (mepolizumab)
• GI-301
• GBR 310
• SYN008
• Fasenra