Crohn's Disease - Pipeline Insight, 2024

This “Crohn’s Disease - Pipeline Insight, 2024” report provides comprehensive insights about 70+ companies and 80+ pipeline drugs in Crohn’s Disease 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

Crohn’s Disease: Understanding

Crohn’s Disease: Overview

Crohn’s disease (CD) is a condition, which is commonly referred to as inflammatory bowel disease (IBD). They are immunologically mediated inflammatory diseases of the gastrointestinal tract. In CD, the inflammation extends through the entire thickness of the bowel wall from the mucosa to the serosa. The disease runs a relapsing and remitting course. With multiple relapses, the CD can progress from initially mild to moderate inflammatory conditions to severe penetrating (fistulization) or stricturing disease. Crohn’s disease can affect any part of the gastrointestinal tract. About one-third of patients have small bowel involvement, especially the terminal ileum, another 20% have only colon involvement and about 50% have involvement of both the colon and small bowel. There is no cure and most patients experience bouts of remissions and relapse at unpredictable times. This disease leads to very poor quality of life.

The pathophysiology is multifactorial and involves genetic predisposition, infectious, immunological, environmental, and dietary. The characteristic transmural inflammation can include the entire GI tract from mouth to the perianal area; although most frequently involve terminal ileum and right colon. The initial lesion starts out as an infiltrate around an intestinal crypt. This goes on to develop ulceration first in the superficial mucosa and involves deeper layers. As the inflammation progresses, non-caseating granulomas form involving all layers of the intestinal wall. It can develop into the classic cobblestone mucosal appearances and skip lesions along the length of the intestine sparing areas with normal mucosa. As the flare of Crohn’s settles, scarring replaces the inflamed areas of the intestines.

Granuloma formation is very common in Crohn’s disease but their absence does not exclude the diagnosis. The ongoing inflammation and scarring lead to bowel obstruction and stricture formation. Crohn’s disease is also associated with enterovesical, enteroenteral, enterocutaneous, and enterovaginal fistulas.

The diagnosis and management of Crohn’s disease is based on clinical signs and symptoms combined with laboratory tests, endoscopy and imaging techniques. Endoscopy is the gold standard for the evaluation of patients with Crohn’s disease. Nevertheless, a correct diagnosis requires radiological examinations to define the extent and stage of the disease and especially to diagnose transmural complications including fistulae, abscesses and phlegmons. Computed tomography (CT) and magnetic resonance imaging (MRI) are indicated in the study of the gastrointestinal tract. Diagnostic sensitivity and specificity of these two methods are similar and both also present certain limitations. CT is widely used and execution time is short, whereas MRI is much less common and requires a longer execution time. However, patients with Crohn’s disease are often young, and the frequency with which they have to undergo radiological examinations should be taken into account, as several trials have suggested that a total exposure to radiation exceeding 50 mSv carries a risk of neoplastic disease. Over the past decade, ultrasound (US) has gradually been introduced to support clinical examination in the diagnosis and monitoring of patients with Crohn’s disease.

Several trials have assessed the diagnostic accuracy of US compared to that of CT and MRI, and the results have led to the recommendations contained in the updated guidelines (2013) of the European Crohn’s and Colitis Organisation (ECCO). The role of endoscopy and biopsy as first-line procedures in patients with suspected Crohn’s disease is reaffirmed, and CT and MRI still remain the gold standard imaging methods in the diagnosis of intestinal involvement and transmural lesions.

The medical compendium for the treatment of Crohn’s disease has increased significantly, enabling treatment beyond symptoms. Indeed, early and timely use of effective medical therapy has been reflected by improved outcomes with reduction in surgery and ability to achieve clinical and endoscopic remission, reduce corticosteroid dependance, and prevent long-term complications in more patients.

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

Crohn’s Disease Emerging Drugs Chapters

This segment of the Crohn’s Disease 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.

Crohn’s Disease Emerging Drugs

Ozanimod: Bristol-Myers Squibb

Ozanimod (Zeposia) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia reduces the capacity of lymphocytes to migrate from lymphoid tissue, reducing the number of circulating lymphocytes in peripheral blood. The company is currently investigating the drug for the treatment of moderately to severely active Crohn’s disease in the ongoing Phase III YELLOWSTONE clinical trial program.

Etrasimod: Pfizer

Etrasimod is an investigational oral drug being studied for the treatment of Crohn's disease. It is a selective sphingosine 1-phosphate receptor modulator designed to treat immune-mediated inflammatory disorders. Clinical trials, such as the CULTIVATE trial, are evaluating the efficacy, safety, and tolerability of etrasimod in subjects with moderately to severely active Crohn's disease. Etrasimod has shown promising results in inducing and maintaining remission in patients with Crohn's disease, demonstrating significant improvements compared to a placebo in clinical trials. Currently, the drug is in the Phase III stage of its development for the treatment of Crohn’s Disease.

CBP-307: Suzhou Connect Biopharmaceuticals

CBP-307 is an orally available, next generation small molecule modulator of the sphingosine-1-phosphate 1 receptor (S1P1), a G-protein coupled receptor (GPCR) that plays a central role in regulating T cell movement and is a validated therapeutic target. S1P1 mediates the transit of T cells from lymph nodes into circulation and, as a result, the migration of T cells to tissues to release inflammatory mediators.6-10 CBP-307 causes T cells to internalize S1P1, trapping T cells inside the lymph nodes and preventing them from migrating to sites of inflammation.CBP-307 has high potency and selectivity11 and is designed to be the most potent modulator of the S1P1 drug class, if approved. CBP-307 has no significant activity for S1P3, a receptor subtype with known safety concerns, and significantly lower potency for S1P4 and S1P5 than S1P1. Currently, the drug is in the Phase II stage of its development for the treatment of Crohn’s Disease.

IMU-856: Immunic

IMU-856 is an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, the compound appears to represent a new and potentially disruptive approach for the treatment of intestinal diseases by potentially restoring the intestinal barrier function while maintaining immunocompetency. Currently, the drug is in the Phase I stage of its development for the treatment of Crohn’s Disease.

Crohn’s Disease: Therapeutic Assessment

This segment of the report provides insights about the different Crohn’s Disease drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Crohn’s Disease

• There are approx. 70+ key companies which are developing the therapies for Crohn’s Disease. The companies which have their Crohn’s Disease drug candidates in the most advanced stage, i.e. phase III include, Bristol-Myers Squibb.

Phases

DelveInsight’s report covers around 80+ 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

Crohn’s Disease 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

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

Crohn’s Disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Crohn’s Disease 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 Crohn’s Disease drugs.

Crohn’s Disease Report Insights

• Crohn’s Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Anssen
• RedHill Biopharma
• Amgen
• Pfizer
• Prometheus Biosciences
• AgomAb Therapeutics
• Hoffmann-La Roche
• Gilead Sciences
• Eli Lilly and Company
• Celgene
• AstraZeneca
• Mesoblast
• Alfasigma
• Tiziana Life Sciences
• Abivax
• Arena Pharmaceuticals
• Cytocom, HAV Vaccines Ltd
• Enzo Biochem Inc.
• Stero Biotechs
• Reistone Biopharma Company Limited
• Qu Biologics
• Pfizer
• Mitsubishi Tanabe Pharma Corporation
• Takeda Pharmaceuticals
• Soligenix
• Immunic
• Pfizer
• Atlantic Healthcare
• 4D Pharma
• Landos Biopharma
• Janssen
• Roche
• Eisai
• Bristol-Myers Squibb

Key Products

• Guselkumab
• ABP-654
• RHB-104
• Etrolizumab
• PRA-023
• AGMB-129
• Filgotinib
• Mirikizumab
• Ozanimod
• Brazikumab
• Remestemcel-L
• Rifaximin
• Foralumab
• ABX-464
• Etrasimod
• CYTO-201
• Masitinib
• HAV anti-MAP vaccine
• Alequel
• Cannabidiol
• SHR0302
• QBECO-SSI
• PRV-6527
• PF-06651600
• MT-1303
• TAK-018
• SGX203
• IMU 838
• Alicaforsen
• Bacteroides thetaiotaomicron
• BT-11
• JNJ-64304500
• E6011

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