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2018 Celiac (Coeliac) Disease Drug Development- Pipeline Analysis Report

April 2018 | | ID: 2DF9D07FA57EN
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Celiac disease is genetic autoimmune disorder caused by incomplete digestion of gluten, which results in toxic peptides leading to inflammation, pain, diarrhea and cramps in abdomen. It affects around 1-3% population globally and around 3 million people in the US with the mean duration for diagnosis being 4 years in the country.

The condition can be diagnosed through blood serum, genetic and biopsy tests. As no approved treatments are available, patients opt for gluten-free diet despite their high costs and lack of taste. Further, despite the gluten free diet, patients continue to suffer problems due to traces of gluten in the gastrointestinal system. Celiac disease is a life time condition and if left untreated, the small intestine (particularly, villi) can be damaged along with several secondary diseases such as osteoporosis, infertility, neurological conditions.
Celiac Disease pipeline comprises of 24 active drugs under active development as of April 2018. Of these, 4 drugs are in Phase 1 and 4 drugs in phase 2. None of the drugs have progressed to Phase 3. Further, 12 drugs are in Pre-clinical stage, 4 drugs in research/discovery stages.

42 companies are developing the pipeline for Celiac Disease. Of this, Takeda Pharmaceutical, ImmunogenX, Innovate Biopharmaceuticals and Amgen have the most advanced compounds in pipeline. Mechanism of Action of most of the therapeutic candidates is Immunomodulators.

To assist researchers and funding and regulatory organizations, VPA Research has come up with a comprehensive report on Pre-eclampsia pipeline. The report provides insights into different therapeutic candidates in preclinical, research, discovery, NDA/IND, pre registration, phase 1, phase 2, and phase 3 trials). Drugs under development directly and through combination with other drugs are also included.

Current status, developmental phase, participating companies and entities, recent developments, orphan drug/fast track/other designations, drug class are provided for each Pre-eclampsia pipeline product. Mechanism of Action and the target area of the pipeline product are also provided. Further, clinical and preclinical trials along with results of the trials are also included in the report.

In addition to complete details of each product, the report provides key trends in Pre-eclampsia pipeline studies. The products under development are categorized according to their development phase, mechanism and company to provide detailed insights into the type of drugs being developed and the stages of development.
1 TABLE OF CONTENTS

1.1 LIST OF FIGURES
1.2 LIST OF TABLES

2 EXECUTIVE SUMMARY

2.1 DISEASE OVERVIEW
2.2 PIPELINE SNAPSHOT
2.3 PIPELINE DRUGS BY PHASE
2.4 PIPELINE DRUGS BY COMPANY
2.5 PIPELINE DRUGS BY MECHANISM OF ACTION

3 CELIAC DISEASE- COMPANY WISE PIPELINE ANALYSIS

3.1 AMGEN INC. PIPELINE, H1 2018
3.2 AMYRA BIOTECH AG PIPELINE, H1 2018
3.3 ANTOLRX, INC. PIPELINE, H1 2018
3.4 BIONIZ, LLC PIPELINE, H1 2018
3.5 CALYPSO BIOTECH SA PIPELINE, H1 2018
3.6 CIRCLE33 LLC PIPELINE, H1 2018
3.7 COUR PHARMACEUTICAL DEVELOPMENT COMPANY, INC PIPELINE, H1 2018
3.8 F. HOFFMANN LA-ROCHE AG PIPELINE, H1 2018
3.9 IMMUNOGENX, LLC PIPELINE, H1 2018
3.10 IMMUSANT INC PIPELINE, H1 2018
3.11 INNOVATE BIOPHARMACEUTICALS, INC PIPELINE, H1 2018
3.12 INTREXON CORP PIPELINE, H1 2018
3.13 KANYOS BIO, INC. PIPELINE, H1 2018
3.14 LIGAND PHARMACEUTICALS PIPELINE, H1 2018
3.15 PROVID PHARMACEUTICALS, INC PIPELINE, H1 2018
3.16 PVP BIOLOGICS, INC PIPELINE, H1 2018
3.17 SELECTA BIOSCIENCES INC. PIPELINE, H1 2018
3.18 SIGMOID PHARMA LIMITED PIPELINE, H1 2018
3.19 SYNTHETIC BIOLOGICS, INC. PIPELINE, H1 2018
3.20 TAKEDA PHARMACEUTICAL COMPANY LTD PIPELINE, H1 2018
3.21 TOPAS THERAPEUTICS GMBH PIPELINE, H1 2018
3.22 VACTECH OY PIPELINE, H1 2018
3.23 ZEDIRA GMBH PIPELINE, H1 2018

4 CELIAC DISEASE DRUG SNAPSHOTS

4.1 AMG-714 DRUG DETAILS
  4.1.1 Snapshot
  4.1.2 Drug Overview
  4.1.3 Mechanism of Action
  4.1.4 Current Status
  4.1.5 Trial Details
4.2 AMY01 DRUG DETAILS
  4.2.1 Snapshot
  4.2.2 Drug Overview
  4.2.3 Mechanism of Action
  4.2.4 Current Status
4.3 ARYL HYDROCARBON RECEPTOR DRUG DETAILS
  4.3.1 Snapshot
  4.3.2 Drug Overview
  4.3.3 Mechanism of Action
  4.3.4 Current Status
  4.3.5 Trial Details
4.4 BNZ-2 DRUG DETAILS
  4.4.1 Snapshot
  4.4.2 Drug Overview
  4.4.3 Mechanism of Action
  4.4.4 Current Status
  4.4.5 Trial Details
4.5 CALY-002 DRUG DETAILS
  4.5.1 Snapshot
  4.5.2 Drug Overview
  4.5.3 Mechanism of Action
  4.5.4 Current Status
4.6 AVX-176 DRUG DETAILS
  4.6.1 Snapshot
  4.6.2 Drug Overview
  4.6.3 Mechanism of Action
  4.6.4 Current Status
4.7 TIMP-GLIA DRUG DETAILS
  4.7.1 Snapshot
  4.7.2 Drug Overview
  4.7.3 Mechanism of Action
  4.7.4 Current Status
  4.7.5 Trial Details
4.8 RG-7625 DRUG DETAILS
  4.8.1 Snapshot
  4.8.2 Drug Overview
  4.8.3 Mechanism of Action
  4.8.4 Current Status
  4.8.5 Trial Details
4.9 INN-202 DRUG DETAILS
  4.9.1 Snapshot
  4.9.2 Drug Overview
  4.9.3 Mechanism of Action
  4.9.4 Current Status
  4.9.5 Trial Details
4.10 IMGX003 DRUG DETAILS
  4.10.1 Snapshot
  4.10.2 Drug Overview
  4.10.3 Mechanism of Action
  4.10.4 Current Status
  4.10.5 Trial Details
4.11 NEXVAX2 DRUG DETAILS
  4.11.1 Snapshot
  4.11.2 Drug Overview
  4.11.3 Mechanism of Action
  4.11.4 Current Status
  4.11.5 Trial Details
4.12 ACTOBIOTICS BIOTHERAPEUTICS FOR CELIAC DISEASE DRUG DETAILS
  4.12.1 Snapshot
  4.12.2 Drug Overview
  4.12.3 Mechanism of Action
  4.12.4 Current Status
4.13 ANTIGEN-SPECIFIC IMMUNE TOLERANCE DRUG DETAILS
  4.13.1 Snapshot
  4.13.2 Drug Overview
  4.13.3 Mechanism of Action
  4.13.4 Current Status
4.14 DQ2/8 DRUG DETAILS
  4.14.1 Snapshot
  4.14.2 Drug Overview
  4.14.3 Mechanism of Action
4.15 KUMAMAX DRUG DETAILS
  4.15.1 Snapshot
  4.15.2 Drug Overview
  4.15.3 Mechanism of Action
  4.15.4 Current Status
4.16 SYNTHETIC VACCINE
  4.16.1 Snapshot
  4.16.2 Drug Overview
  4.16.3 Mechanism of Action
  4.16.4 Current Status
4.17 VEDOLIZUMAB DRUG DETAILS
  4.17.1 Snapshot
  4.17.2 Drug Overview
  4.17.3 Mechanism of Action
  4.17.4 Current Status
  4.17.5 Trial Details
4.18 NANO-PARTICLE TECHNOLOGY FOR CELIAC DISEASE DRUG DETAILS
  4.18.1 Snapshot
  4.18.2 Drug Overview
  4.18.3 Mechanism of Action
  4.18.4 Current Status
4.19 ZED-1227 DRUG DETAILS
  4.19.1 Snapshot
  4.19.2 Drug Overview
  4.19.3 Mechanism of Action
  4.19.4 Current Status
  4.19.5 Trial Details
4.20 NEXVAX3 DRUG DETAILS
  4.20.1 Snapshot
4.21 TRANSGLUTAMINASE MODULATORS (LIGAND)
  4.21.1 Snapshot
  4.21.2 Mechanism of Action
  4.21.3 Current Status
4.22 SMPILL FORMULATIONS DRUG DETAILS
  4.22.1 Snapshot
  4.22.2 Drug Overview
  4.22.3 Mechanism of Action
  4.22.4 Current Status
4.23 SYN 020 DRUG DETAILS
  4.23.1 Snapshot
  4.23.2 Drug Overview
  4.23.3 Mechanism of Action
  4.23.4 Current Status
4.24 CELIAC VACCINE (VACTECH) DETAILS
  4.24.1 Snapshot
  4.24.2 Drug Overview
  4.24.3 Mechanism of Action
  4.24.4 Current Status

5 RECENT DEVELOPMENTS IN CELIAC DISEASE PIPELINE

5.1 BIONIZ THERAPEUTICS PRESENTS DATA DEMONSTRATING THE SYNERGISTIC EFFECTS OF CYTOKINES IL-15 AND IL-21 IN CELIAC DISEASE PATHOGENESIS - 2017
5.2 COUR PHARMACEUTICALS RECEIVES FDA FAST TRACK DESIGNATION FOR TIMP-GLIA- 2018
5.3 INNOVATE BIOPHARMACEUTICALS TO HIGHLIGHT PROGRESS IN CELIAC DISEASE AND NASH AT THE COWEN HEALTHCARE CONFERENCE- 2018
5.4 NIH AWARDS GRANT TO IMMUNOGENX TO STUDY LATIGLUTENASE- 2017
5.5 INTREXON TO DEVELOP DISEASE-MODIFYING THERAPIES IN NEW COLLABORATIONS WITH HARVEST INTREXON ENTERPRISE FUND- 2016
5.6 PVP BIOLOGICS AND TAKEDA DEAL- 2017
5.7 DR. FALK PHARMA AND ZEDIRA ANNOUNCE COMPLETION OF PHASE 1B CLINICAL TRIAL OF ZED1227 FOR THE TREATMENT OF CELIAC DISEASE- 2017

6 APPENDIX

6.1 ABOUT VPA RESEARCH
6.2 SOURCES AND RESEARCH METHODOLOGY

LIST OF FIGURES

Figure 1: Celiac Disease Pipeline by Phase, H1- 2018
Figure 2: Celiac Disease Pipeline by Companies, H1- 2018
Figure 3: Company wise Pipeline Drug Phases, H1- 2018
Figure 4: Celiac Disease Pipeline by Mechanism of Action, H1- 2018
Figure 5: Mechanism wise Pipeline Drug Phases, H1- 2018

LIST OF TABLES

Table 1: Celiac Disease Pipeline by Phase, H1- 2018
Table 2: Celiac Disease Pipeline by Companies, H1- 2018 (1)
Table 3: Celiac Disease Pipeline by Companies, H1- 2018 (2)
Table 4: Celiac Disease Pipeline by Mechanism of Action, H1- 2018
Table 5: Amgen Inc. Celiac Disease Pipeline, H1- 2018
Table 6: Amyra Biotech AG Celiac Disease Pipeline, H1- 2018
Table 7: AnTolRx, Inc. Celiac Disease Pipeline, H1- 2018
Table 8: Bioniz, LLC Celiac Disease Pipeline, H1- 2018
Table 9: Calypso Biotech SA Celiac Disease Pipeline, H1- 2018
Table 10: Circle33 LLC Celiac Disease Pipeline, H1- 2018
Table 11: Cour Pharmaceutical Development Company, Inc Celiac Disease Pipeline, H1- 2018
Table 12: Celiac Disease Pipeline, H1- 2018
Table 13: ImmunogenX, LLC Celiac Disease Pipeline, H1- 2018
Table 14: ImmusanT Inc Celiac Disease Pipeline, H1- 2018
Table 15: Innovate Biopharmaceuticals, Inc Celiac Disease Pipeline, H1- 2018
Table 16: Intrexon Corp Celiac Disease Pipeline, H1- 2018
Table 17: Kanyos Bio, Inc. Celiac Disease Pipeline, H1- 2018
Table 18: Ligand Pharmaceuticals Celiac Disease Pipeline, H1- 2018
Table 19: Provid Pharmaceuticals, Inc Celiac Disease Pipeline, H1- 2018
Table 20: PvP Biologics, Inc Celiac Disease Pipeline, H1- 2018
Table 21: Selecta Biosciences Inc. Celiac Disease Pipeline, H1- 2018
Table 22: Sigmoid Pharma Limited Celiac Disease Pipeline, H1- 2018
Table 23: Synthetic Biologics, Inc. Celiac Disease Pipeline, H1- 2018
Table 24: Takeda Pharmaceutical Company Ltd Celiac Disease Pipeline, H1- 2018
Table 25: Topas Therapeutics GmbH Celiac Disease Pipeline, H1- 2018
Table 26: Vactech Oy Celiac Disease Pipeline, H1- 2018
Table 27: Zedira GmbH Celiac Disease Pipeline, H1- 2018


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