Renal Diseases Drug Development Pipeline Review, 2018

This report provides an overview of the pipeline landscape for renal diseases. It provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for chronic kidney disease (chronic renal failure), kidney fibrosis, polycystic kidney disease and end-stage kidney disease (end-stage renal disease), and features dormant and discontinued products.

Chronic kidney disease is the slow loss of kidney function over time. Signs and symptoms of kidney disease include nausea, vomiting, loss of appetite, fatigue and weakness, sleep problems, hiccups and swelling of the feet and ankles. The predisposing factors include age, diabetes, high blood pressure, heart disease, smoking, obesity and high cholesterol. There are 58 products in development for this indication.

Accumulation of extracellular matrix in the kidney causes kidney fibrosis. It is a progressive disorder characterized by glomerulosclerosis and tubulointerstitial fibrosis and may lead to detrimental effects on the kidney functioning. Predisposing factors are trauma, injury, infections, surgery, environmental factors and exposure to chemicals or radiation. Symptoms include pain, problems related to urination, nausea and vomiting. The condition may be managed with medication and kidney transplant. There are 49 products in development for this indication.

Polycystic kidney disease is a disorder in which clusters of cysts develop primarily within the kidneys. Polycystic kidney disease symptoms may include high blood pressure, back or side pain, headache, blood in the urine, frequent urination and kidney failure. The predisposing factors include age and family history. Treatment includes antihypertensive drugs and diuretics. There are 26 products in development for this indication.

End-stage kidney disease is the complete or almost complete failure of the kidneys to work. Symptoms include inability to urinate, fatigue, headaches, loss of appetite, nausea and vomiting, bone pain, confusion and difficulty concentrating. The risk factors include polycystic kidney disease, Alport syndrome, interstitial nephritis and certain autoimmune conditions, such as lupus. Treatment includes dialysis or kidney transplant. There are five products in development for this indication.

Molecular targets in development for renal diseases include growth factor receptors, chemokines and kinases. Companies operating in this pipeline space include Angion Biomedica, Prolong Pharmaceuticals and Novartis.

Scope

– Which companies are the most active within each pipeline?

– Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication?

– To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?

– What are the most important R&D milestones and data publications to have happened in this disease area?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication

- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication and a comprehensive picture of recent updates and milestones for each

- Analyze the companies, institutions and universities currently operating in the pipeline and the products being fielded by each of these

- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

Companies mentioned

AdAlta Ltd

Allena Pharmaceuticals Inc

apceth Biopharma GmbH

Arch Biopartners Inc

Astellas Pharma Inc

AstraZeneca Plc

Bayer AG

BiOrion Technologies BV

Boehringer Ingelheim GmbH

Boryung Pharmaceutical Co Ltd

Celgene Corp

Certa Therapeutics Pty Ltd

Conatus Pharmaceuticals Inc

Corvidia Therapeutics Inc

DiaMedica Therapeutics Inc

Dimerix Bioscience Pty Ltd

DiscoveryBiomed Inc

DURECT Corp

Epigen Biosciences Inc

Galectin Therapeutics Inc

GenKyoTex SA

GNI Group Ltd

iBio Inc

IC-MedTech Inc

Ipsen SA

Isarna Therapeutics GmbH

KBP BioSciences Co Ltd

Kidney Fibrosis

Klotho Therapeutics Inc

Les Laboratoires Servier SAS

ManRos Therapeutics

Mironid Ltd

NovaTarg Therapeutics Inc

Novo Nordisk AS

OPKO Health Inc

Opsidio LLC

Otsuka Holdings Co Ltd

Pharmaxis Ltd

Q BioMed Inc

Redx Pharma Plc

Regulus Therapeutics Inc

Resverlogix Corp

Sanwa Kagaku Kenkyusho Co Ltd

Sarfez Pharmaceuticals Inc

Scholar Rock Inc

Sirnaomics Inc

Sphaera Pharma Pte Ltd

Symic Biomedical Inc

Taisho Pharmaceutical Holdings Co Ltd

Theravance Biopharma Inc

Unity Biotechnology Inc

Vascular Biogenics Ltd

Vascular BioSciences

VESSL Therapeutics Ltd

Vicore Pharma AB

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 5

1.2 List of Figures 7

2 Introduction 9

2.1 Renal Diseases Report Coverage 9

2.2 Chronic Kidney Disease (Chronic Renal Failure) - Overview 9

2.3 Kidney Fibrosis - Overview 9

2.4 Polycystic Kidney Disease - Overview 9

2.5 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) - Overview 9

3 Therapeutics Development 10

3.1 Chronic Kidney Disease (Chronic Renal Failure) 10

3.2 Kidney Fibrosis 19

3.3 Polycystic Kidney Disease 25

3.4 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 30

4 Therapeutics Assessment 33

4.1 Chronic Kidney Disease (Chronic Renal Failure) 33

4.2 Kidney Fibrosis 40

4.3 Polycystic Kidney Disease 48

4.4 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 56

5 Companies Involved in Therapeutics Development 61

5.1 Chronic Kidney Disease (Chronic Renal Failure) 61

5.2 Kidney Fibrosis 80

5.3 Polycystic Kidney Disease 93

5.4 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 99

6 Dormant Projects 102

6.1 Chronic Kidney Disease (Chronic Renal Failure) 102

6.2 Kidney Fibrosis 106

6.3 Polycystic Kidney Disease 107

6.4 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 109

7 Discontinued Products 110

7.1 Chronic Kidney Disease (Chronic Renal Failure) 110

7.2 Kidney Fibrosis 111

7.3 Polycystic Kidney Disease 111

7.4 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 111

8 Product Development Milestones 112

8.1 Chronic Kidney Disease (Chronic Renal Failure) 112

8.2 Kidney Fibrosis 127

8.3 Polycystic Kidney Disease 139

9 Appendix 153

9.1 Methodology 153

9.2 Coverage 153

9.3 Secondary Research 153

9.4 Primary Research 153

9.5 Expert Panel Validation 153

9.6 Contact Us 153

9.7 Disclaimer 154

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Chronic Kidney Disease (Chronic Renal Failure) 10

Table 2: Number of Products under Development by Companies, Chronic Kidney Disease (Chronic Renal Failure) 12

Table 3: Number of Products under Development by Universities/Institutes, Chronic Kidney Disease (Chronic Renal Failure) 14

Table 4: Products under Development by Companies, Chronic Kidney Disease (Chronic Renal Failure) 15

Table 5: Products under Development by Universities/Institutes, Chronic Kidney Disease (Chronic Renal Failure) 18

Table 6: Number of Products under Development for Kidney Fibrosis 19

Table 7: Number of Products under Development by Companies, Kidney Fibrosis 21

Table 8: Number of Products under Development by Universities/Institutes, Kidney Fibrosis 22

Table 9: Products under Development by Companies, Kidney Fibrosis 23

Table 10: Products under Development by Universities/Institutes, Kidney Fibrosis 25

Table 11: Number of Products under Development for Polycystic Kidney Disease, Kidney Fibrosis 26

Table 12: Number of Products under Development by Companies, Kidney Fibrosis 27

Table 13: Number of Products under Development by Universities/Institutes, Kidney Fibrosis 27

Table 14: Products under Development by Companies, Kidney Fibrosis 28

Table 15: Products under Development by Universities/Institutes, Kidney Fibrosis 29

Table 16: Number of Products under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 30

Table 17: Number of Products under Development by Companies, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 31

Table 18: Products under Development by Companies, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 32

Table 19: Number of Products by Stage and Target, Chronic Kidney Disease (Chronic Renal Failure) 34

Table 20: Number of Products by Stage and Mechanism of Action, Chronic Kidney Disease (Chronic Renal Failure) 36

Table 21: Number of Products by Stage and Route of Administration, Chronic Kidney Disease (Chronic Renal Failure) 38

Table 22: Number of Products by Stage and Molecule Type, Chronic Kidney Disease (Chronic Renal Failure) 40

Table 23: Number of Products by Stage and Target, Kidney Fibrosis 42

Table 24: Number of Products by Stage and Mechanism of Action, Kidney Fibrosis 45

Table 25: Number of Products by Stage and Route of Administration, Kidney Fibrosis 46

Table 26: Number of Products by Stage and Molecule Type, Kidney Fibrosis 48

Table 27: Number of Products by Stage and Target, Polycystic Kidney Disease 50

Table 28: Number of Products by Stage and Mechanism of Action, Polycystic Kidney Disease 52

Table 29: Number of Products by Stage and Route of Administration, Polycystic Kidney Disease 54

Table 30: Number of Products by Stage and Molecule Type, Polycystic Kidney Disease 55

Table 31: Number of Products by Stage and Target, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 57

Table 32: Number of Products by Stage and Mechanism of Action, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 58

Table 33: Number of Products by Stage and Route of Administration, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 58

Table 34: Number of Products by Stage and Molecule Type, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 60

Table 35: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Allena Pharmaceuticals Inc 61

Table 36: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Angion Biomedica Corp 61

Table 37: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by apceth Biopharma GmbH 62

Table 38: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Arch Biopartners Inc 62

Table 39: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Astellas Pharma Inc 63

Table 40: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by AstraZeneca Plc 64

Table 41: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Bayer AG 64

Table 42: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Boehringer Ingelheim GmbH 65

Table 43: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Boryung Pharmaceutical Co Ltd 65

Table 44: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Cellmid Ltd 66

Table 45: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Corvidia Therapeutics Inc 66

Table 46: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by DiaMedica Therapeutics Inc 67

Table 47: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Dimerix Bioscience Pty Ltd 67

Table 48: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by DURECT Corp 68

Table 49: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Evotec AG 69

Table 50: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by GNI Group Ltd 69

Table 51: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by KBP BioSciences Co Ltd 70

Table 52: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Klotho Therapeutics Inc 70

Table 53: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Nash Pharmaceuticals Inc 71

Table 54: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Novartis AG 71

Table 55: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by OPKO Health Inc 72

Table 56: Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Opsidio LLC 72

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Chronic Kidney Disease (Chronic Renal Failure) 10

Figure 2: Number of Products under Development by Companies, Chronic Kidney Disease (Chronic Renal Failure) 11

Figure 3: Number of Products under Development by Universities/Institutes, Chronic Kidney Disease (Chronic Renal Failure) 14

Figure 4: Number of Products under Development for Kidney Fibrosis 19

Figure 5: Number of Products under Development by Companies, Kidney Fibrosis 20

Figure 6: Number of Products under Development for Polycystic Kidney Disease, Kidney Fibrosis 25

Figure 7: Number of Products under Development by Companies, Kidney Fibrosis 26

Figure 8: Number of Products under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 30

Figure 9: Number of Products under Development by Companies, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 31

Figure 10: Number of Products by Top 10 Targets, Chronic Kidney Disease (Chronic Renal Failure) 33

Figure 11: Number of Products by Stage and Top 10 Targets, Chronic Kidney Disease (Chronic Renal Failure) 33

Figure 12: Number of Products by Top 10 Mechanism of Actions, Chronic Kidney Disease (Chronic Renal Failure) 35

Figure 13: Number of Products by Stage and Top 10 Mechanism of Actions, Chronic Kidney Disease (Chronic Renal Failure) 35

Figure 14: Number of Products by Routes of Administration, Chronic Kidney Disease (Chronic Renal Failure) 37

Figure 15: Number of Products by Stage and Routes of Administration, Chronic Kidney Disease (Chronic Renal Failure) 38

Figure 16: Number of Products by Top 10 Molecule Types, Chronic Kidney Disease (Chronic Renal Failure) 39

Figure 17: Number of Products by Stage and Top 10 Molecule Types, Chronic Kidney Disease (Chronic Renal Failure) 39

Figure 18: Number of Products by Top 10 Targets, Kidney Fibrosis 40

Figure 19: Number of Products by Stage and Top 10 Targets, Kidney Fibrosis 41

Figure 20: Number of Products by Top 10 Mechanism of Actions, Kidney Fibrosis 43

Figure 21: Number of Products by Stage and Top 10 Mechanism of Actions, Kidney Fibrosis 44

Figure 22: Number of Products by Stage and Routes of Administration, Kidney Fibrosis 46

Figure 23: Number of Products by Top 10 Molecule Types, Kidney Fibrosis 47

Figure 24: Number of Products by Stage and Top 10 Molecule Types, Kidney Fibrosis 47

Figure 25: Number of Products by Top 10 Targets, Polycystic Kidney Disease 48

Figure 26: Number of Products by Stage and Top 10 Targets, Polycystic Kidney Disease 49

Figure 27: Number of Products by Top 10 Mechanism of Actions, Polycystic Kidney Disease 51

Figure 28: Number of Products by Stage and Top 10 Mechanism of Actions, Polycystic Kidney Disease 51

Figure 29: Number of Products by Routes of Administration, Polycystic Kidney Disease 53

Figure 30: Number of Products by Stage and Routes of Administration, Polycystic Kidney Disease 53

Figure 31: Number of Products by Molecule Types, Polycystic Kidney Disease 54

Figure 32: Number of Products by Stage and Molecule Types, Polycystic Kidney Disease 55

Figure 33: Number of Products by Targets, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 56

Figure 34: Number of Products by Stage and Targets, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 56

Figure 35: Number of Products by Mechanism of Actions, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 57

Figure 36: Number of Products by Stage and Mechanism of Actions, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 58

Figure 37: Number of Products by Molecule Types, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 59

Figure 38: Number of Products by Stage and Molecule Types, End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 59

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