Ulcerative Colitis - Pipeline Insight, 2024

This “Ulcerative Colitis - Pipeline Insight, 2024” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Ulcerative Colitis 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

Ulcerative Colitis: Understanding

Ulcerative Colitis: Overview

Ulcerative colitis is an idiopathic inflammatory condition of the colon that results in diffuse friability and superficial erosions on the colonic wall associated with bleeding. It is the most common form of inflammatory bowel disease worldwide. It characteristically involves inflammation restricted to the mucosa and submucosa of the colon. Typically, the disease starts in the rectum and extends proximally in a continuous manner. In the United States, the disease accounts for a quarter-million provider visits annually, and medical costs directly related to the disease are estimated to exceed four billion dollars annually. The specific cause of inflammatory bowel disease is not known. There seems to be a primary genetic component since the most important independent risk factor is a family history of the disease (8% to 14% of patients). A first-degree relative of a patient with ulcerative colitis has a four times higher risk of developing the disease. Additionally, ulcerative colitis has a higher incidence in Jewish populations than other ethnicities. The pathophysiology of ulcerative colitis involves defects in the epithelial barrier, immune response, leukocyte recruitment, and microflora of the colon. The epithelial barrier has a defect in colonic mucin and possibly tight junctions, leading to increased uptake of luminal antigens. The lamina propria of the mucosa also has an increased number of activated and mature dendritic cells, which include a large number of toll-like receptors (TLR), specifically TLR2 and TLR4. There also seems to be an atypical T-helper (Th) cell response in patients with ulcerative colitis, specifically Th2, which exerts a cytotoxic response against epithelial cells. Leukocyte recruitment is affected on two fronts. There is an upregulated release of the chemoattractant CXCL8 in ulcerative colitis so that leukocytes are recruited to the mucosa from systemic circulation. Additionally, there is an upregulation of mucosal cellular adhesion molecule-1 (Mad-CAM1) on the endothelium of mucosal blood vessels, which promotes leukocyte adhesion and extravasation into mucosal tissue. Studies have shown that enteric microflora is important in the pathogenesis and severity of inflammation and disease phenotype. Ulcerative colitis seems also to result, in part, from a homeostatic imbalance between enteric microflora and the host's mucosal immunity. This results in an aberrant response to non-pathogenic bacteria.

Ulcerative colitis is diagnosed clinically with supportive findings on endoscopy, biopsy, and negative stool examination for infectious causes. Radiologic examinations are not critical for diagnosis but may be useful. Colonoscopy or proctosigmoidoscopy might reveal loss of typical vascular pattern, granularity, friability, and ulceration, which involve the distal rectum and proceed proximally in a symmetric, continuous, and circumferential pattern. Laboratory evaluation will usually reveal an increase in inflammatory factors, especially during an acute flare. An endoscopy (colonoscopy) must be done at some point which will reveal fragile mucosa, granular mucosa, loss of vascular pattern, presence of erosions and pseudopolyposis. Multiple biopsies should be obtained to confirm the diagnosis. The most common classification system used to determine the extent and severity of the disease is the Montreal classification system. Treatment choice for patients with ulcerative colitis is based on both the extent of the disease and the severity. The prognosis during the first decade after diagnosis is often generally good, and most patients go into remission. Rectal application of medical therapy, via suppository or enema, is usually appropriate for isolated distal disease (proctitis); however, a rectal application is usually used in combination with systemic therapy to help target the distal colon and, therefore, decrease tenesmus. Ulcerative colitis can be treated with medications such as aminosalicylates, glucocorticoids, thiopurines, and biological drugs. Probiotics and fecal microbiota transplantation may also be helpful. Colectomy is curative in patients with ulcerative colitis. Colonoscopy is recommended at regular intervals due to the risk of colon cancer. There is no specific diet for patients with ulcerative colitis, but lactose intolerance is common.

“Ulcerative Colitis - Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the mechanism of action. A detailed picture of the Ulcerative Colitis pipeline landscape is provided which includes the disease overview and Ulcerative Colitis treatment guidelines. The assessment part of the report embraces, in depth Ulcerative Colitis 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, Ulcerative Colitis 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 Ulcerative Colitis R&D. The therapies under development are focused on novel approaches to treat/improve Ulcerative Colitis.

Ulcerative Colitis Emerging Drugs Chapters

This segment of the Ulcerative Colitis 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.

Ulcerative Colitis Emerging Drugs

Obefazimod: AbivaxObefazimod is an oral small-molecule drug candidate in clinical development for the treatment of moderately to severely active ulcerative colitis (UC) and has demonstrated anti-inflammatory activity in preclinical studies and in both Phase IIa and Phase IIb clinical trials. Currently, the drug is in Phase III stage of its clinical trial for the treatment of ulcerative colitis.

ABBV-668: AbbVieABBV-668 is under development for the treatment of crohn's disease, unspecified immunological disorders and ulcerative colitis. The drug candidate acts by targeting receptor interacting serine/threonine protein kinase 1 (RIPK1). It is administered through oral route. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.

TEV-48574: Teva PharmaceuticalAnti-TL1A (TEV-’574) is a potentially best-in-class human IgG1 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15. TL1A signaling is believed to amplify inflammation and drives fibrosis associated with asthma and inflammatory bowel disease (IBD); thus, targeting TL1A with TEV-’574 may mitigate the over-active immune response in these conditions. Anti-TL1A (TEV-’574) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UD) and Crohn's disease (CD), two types of inflammatory bowel disease. The safety and efficacy of anti-TL1A (TEV-’574) have not been reviewed by any regulatory authority. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.

SOR102: Sorriso PharmaceuticalsSOR102 combines anti-TNF and anti-IL-23 vorabodies into a single dual-acting molecule a trypsin cleavable linker releases the monomers to independently engage their targets throughout intestinal tissue. SOR102 provides combination therapy locally within inflamed tissue with minimal risk of systemic immunosuppression. Overall benefits of dual targeting approach increased efficacy through blockade of different inflammatory mechanisms of IBD. Currently, the drug is in Phase I stage of its clinical trial for the treatment of ulcerative colitis.

Ulcerative Colitis: Therapeutic Assessment

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

Major Players in Ulcerative Colitis

There are approx. 70+ key companies which are developing the therapies for Ulcerative Colitis. The companies which have their Ulcerative Colitis drug candidates in the most advanced stage, i.e. Phase III include Abivax.

Phases

This report covers around 75+ 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

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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

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

Ulcerative Colitis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Ulcerative Colitis 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 Ulcerative Colitis drugs.

Ulcerative Colitis Report Insights

• Ulcerative Colitis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Oppilan Pharma
• Genentech
• Teva Branded Pharmaceutical
• Boehringer Ingelheim
• Sorriso Pharmaceuticals
• Reistone Biopharma
• Celgene
• AnaptysBio
• Rise Therapeutics
• Merck
• AltruBio
• AbbVie
• Immunic AG
• Kissei Pharmaceutical Co
• Lmito Therapeutics
• Morphic Therapeutic
• Oncostellae
• Palatin Technologies

Key Products

• VTX002
• Vixarelimab
• TEV-48574
• Spesolimab
• SOR102
• SHR0302
• RPC1063
• Rosnilimab
• R-3750
• MK-7240
• ALTB-268
• ABBV-668
• IMU-838
• KSP-0243
• LMT503
• MORF-057
• OST-122
• PL8177

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