Celiac Disease - Pipeline Insight, 2024

This “Celiac Disease- Pipeline Insight, 2024,” report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in Celiac 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

Celiac Disease Understanding

Celiac Disease: Overview

Celiac disease is a serious autoimmune disease that occurs in genetically predisposed people where the ingestion of gluten leads to damage in the small intestine. It is estimated to affect 1 in 100 people worldwide. Two and one-half million Americans are undiagnosed and are at risk for long-term health complications. Celiac disease is hereditary, meaning that it runs in families. People with a first-degree relative with celiac disease (parent, child,sibling) have a 1 in 10 risk of developing celiac disease. When people with celiac disease eat gluten (a protein found in wheat, rye and barley), their body mounts an immune response that attacks the small intestine. These attacks lead to damage on the villi, small fingerlike projections that line the small intestine, that promote nutrient absorption. When the villi get damaged, nutrients cannot be absorbed properly into the body. Celiac disease can develop at any age after people start eating foods or medicines that contain gluten. Left untreated, celiac disease can lead to additional serious health problems. Currently, the only treatment for celiac disease is lifelong adherence to a strict gluten-free diet. People living gluten-free must avoid foods with wheat, rye and barley, such as bread and beer. Untreated celiac disease can lead to the development of other autoimmune disorders like Type I diabetes and multiple sclerosis (MS), and many other conditions, including dermatitis herpetiformis (an itchy skin rash), anemia, osteoporosis, infertility and miscarriage, neurological conditions like epilepsy and migraines, short stature, heart disease and intestinal cancers.

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

Celiac Disease Emerging Drugs Chapters

This segment of the Celiac 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.

Celiac Disease Emerging Drugs

• Larazotide - 9 Meters Biopharma

Larazotide is designed to mitigate the life-altering symptoms that people with celiac disease may experience when they ingest gluten. Specifically, larazotide prevents gluten breakdown product, gliadin, from entering the systemic circulation through compromised tight junctions between intestinal cells that occur in celiac disease, and in turn propagating an inflammatory response in the gut. 9 Meters aims to introduce larazotide as an adjunctive therapy in tandem with a gluten-free diet in adults with celiac disease to restore tight junctions between intestinal cells, mitigate gliadin leakage, and thus minimize symptoms.

CNP- 101: Cour Pharmaceutical CNP-101, a biodegradable nanoparticle encapsulating gliadin proteins - the major component of dietary gluten. CNP-101 is the first agent to induce antigen-specific immune tolerance in any autoimmune disease. In a Phase 2, double-blind, placebo-controlled clinical trial, patients with celiac disease were treated with CNP-101 and, starting one week later, were fed wheat gluten for 14 days. While patients receiving placebo developed severe immune responses to gliadin and damaging inflammation in their small intestine, patients treated CNP-101 showed significantly less inflammation. In addition, CNP-101 showed a trend toward protecting the intestines from gluten-related injury when compared to untreatedpatients.

Latiglutenase: Immunogenics Latiglutenase (IMGX003) is an orally administered mixture of two gluten-specific recombinant proteases that degrades gluten proteins into small physiologically irrelevant fragments, and is to be administered as an adjunct to a gluten-free diet (GFD). IMGX001 is effective at breaking glutamine-leucine bonds and the other protease (IMGX002) targets most proline bonds. In Phase IIa and IIb clinical trials Latiglutenase has been shown to mitigate gluten-induced intestinal mucosal injury as well reduce the severity and frequency of symptoms in celiac disease patients. ImmunogenX is beginning a Phase II gluten-challenge study to investigate both mucosal and symptomatic protection in a general population of CD patients. This study will be followed shortly by a Phase II/III real-world trial that will focus on symptom improvement in seropositive patients as a prelude to a Phase IIItrial.

• Ordesekimab - Amgen

Ordesekimab (formally AMG 714) is a monoclonal antibody that inhibits the action of Interleukin-15 (IL-15). It is being investigated for the treatment of celiac disease. Ordesekimab is being developed in collaboration with Provention Bio .The drug is currently being investigated in phase 2 stage of development for the treatment of Celiac Disease
CALY 002: Calypso Biotech CALY-002 the lead program of Calypso Biotech, is a best-in-class humanized monoclonal antibody inhibiting Interleukin-15 (IL-15). IL-15 is a cytokine mainly expressed by monocytes, dendritic cells and epithelial cells. IL-15 plays multiple roles in the immune system by controlling the homeostasis and activation of T, B, NK and tissue resident memory T cells. CALY-002 is well positioned as paradigm-changing treatment for several gastrointestinal indications with currently no approved treatment, as well as other large immunepathologies.

BNZ-2: Bioniz BNZ-2 is also an inhibitor of members of the IL-2 family. It is a Phase 1 ready selective inhibitor of IL-15 and IL-21. A growing body of evidence implicates IL-15 and IL-21 in a number of inflammatory diseases of the GI tract including celiac disease, IBD, Type I diabetes, and NASH, providing a strong rationale for applicability of BNZ-2 in these diseases. In preclinical toxicology studies, BNZ-2 treatment resulted in a dose-dependent decrease of both B-cells and CD8-effector cells, indicating the inhibition of both IL-15 and IL-21. Furthermore, BNZ-2 was shown to completely protect the integrity of the gut in an animal model of GI tract inflammation and to prevent a key disease burden, infiltration of lymphocytes to the gut epitheliallayer.

Celiac Disease: Therapeutic Assessment

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

Major Players in Celiac Disease

There are approx. 25+ key companies which are developing the therapies for Celiac Disease. The companies which have their Celiac Disease drug candidates in the most advanced stage, i.e. phase III include, 9 Meters Biopharma

Phases

This report covers around 25+ 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

Celiac 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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• 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.

Celiac Disease: Pipeline Development Activities

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

Celiac Disease Report Insights

• Celiac Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• 9 Metres Biopharma
• Amgen, Allero Therapeutics
• Takeda
• Calypso Biotech
• Anokion
• Zedira GmbH
• Millennium Pharmaceuticals
• ImmunogenX
• GlaxoSmithKline
• ImmusanT
• ActoBio Therapeutics
• Amyra biotech

Key Products

• BNZ-2
• Larazotide
• Latiglutenase
• AMG 714/ PRV-015
• TAK-101
• ZED1227
• CALY 002
• KAN 101
• PvP001
• GSK 3915393
• ALL-001

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