Homozygous Familial Hypercholesterolemia (HoFH) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Homozygous Familial Hypercholesterolemia (HoFH) – Pipeline Review, H2 2016’, provides an overview of the Homozygous Familial Hypercholesterolemia (HoFH) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Homozygous Familial Hypercholesterolemia (HoFH), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Homozygous Familial Hypercholesterolemia (HoFH) and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

The report provides a snapshot of the global therapeutic landscape of Homozygous Familial Hypercholesterolemia (HoFH)

The report reviews pipeline therapeutics for Homozygous Familial Hypercholesterolemia (HoFH) by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved Homozygous Familial Hypercholesterolemia (HoFH) therapeutics and enlists all their major and minor projects

The report assesses Homozygous Familial Hypercholesterolemia (HoFH) therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news related to pipeline therapeutics for Homozygous Familial Hypercholesterolemia (HoFH)

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of therapeutics under development for Homozygous Familial Hypercholesterolemia (HoFH)

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Homozygous Familial Hypercholesterolemia (HoFH) pipeline depth and focus of Indication therapeutics

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Companies mentioned

ARMO Biosciences Inc

CymaBay Therapeutics Inc

Gemphire Therapeutics Inc

LipimetiX Development Inc

Regeneron Pharmaceuticals Inc

RegenxBio Inc

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Homozygous Familial Hypercholesterolemia (HoFH) Overview 6

Therapeutics Development 7

Pipeline Products for Homozygous Familial Hypercholesterolemia (HoFH) - Overview 7

Homozygous Familial Hypercholesterolemia (HoFH) - Therapeutics under Development by Companies 8

Homozygous Familial Hypercholesterolemia (HoFH) - Pipeline Products Glance 10

Clinical Stage Products 10

Early Stage Products 11

Homozygous Familial Hypercholesterolemia (HoFH) - Products under Development by Companies 12

Homozygous Familial Hypercholesterolemia (HoFH) - Companies Involved in Therapeutics Development 13

ARMO Biosciences Inc 13

CymaBay Therapeutics Inc 14

Gemphire Therapeutics Inc 15

LipimetiX Development Inc 16

Regeneron Pharmaceuticals Inc 17

RegenxBio Inc 18

Homozygous Familial Hypercholesterolemia (HoFH) - Therapeutics Assessment 19

Assessment by Monotherapy Products 19

Assessment by Target 20

Assessment by Mechanism of Action 22

Assessment by Route of Administration 24

Assessment by Molecule Type 26

Drug Profiles 28

AEM-28 - Drug Profile 28

Product Description 28

Mechanism Of Action 28

R&D Progress 28

AEM-2802 - Drug Profile 30

Product Description 30

Mechanism Of Action 30

R&D Progress 30

AEM-2814 - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

AM-0010 - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

evinacumab - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

gemcabene calcium - Drug Profile 37

Product Description 37

Mechanism Of Action 37

R&D Progress 37

MBX-8025 - Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

MGL-3196 - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

MGL-3745 - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

RGX-501 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

Homozygous Familial Hypercholesterolemia (HoFH) - Dormant Projects 47

Homozygous Familial Hypercholesterolemia (HoFH) - Product Development Milestones 48

Featured News & Press Releases 48

Sep 26, 2016: Gemphire Therapeutics Enrolls First Patient in the COBALT-1 Trial Investigating Gemcabene in Homozygous Familial Hypercholesterolemia 48

May 31, 2016: Regeneron Presents Positive Interim Data from Phase 2 Proof-of-Concept Study of Evinacumab in Patients with Homozygous Familial Hypercholesterolemia 48

Mar 17, 2016: CymaBay Therapeutics Announces Positive Results from its Pilot Phase 2 Clinical Study of MBX-8025 in Patients with Homozygous Familial Hypercholesterolemia 49

Apr 23, 2015: CymaBay Therapeutics Announces the Initiation of a Phase 2 Study of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia 50

Mar 25, 2015: CymaBay Therapeutics Announces U.S. Orphan Drug Designation for MBX-8025 in Homozygous Familial Hypercholesterolemia 51

Appendix 52

Methodology 52

Coverage 52

Secondary Research 52

Primary Research 52

Expert Panel Validation 52

Contact Us 52

Disclaimer 53

List of Tables

List of Tables

Number of Products under Development for Homozygous Familial Hypercholesterolemia (HoFH), H2 2016 7

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Clinical Stage Development, H2 2016 10

Comparative Analysis by Early Stage Development, H2 2016 11

Products under Development by Companies, H2 2016 12

Homozygous Familial Hypercholesterolemia (HoFH) – Pipeline by ARMO Biosciences Inc, H2 2016 13

Homozygous Familial Hypercholesterolemia (HoFH) – Pipeline by CymaBay Therapeutics Inc, H2 2016 14

Homozygous Familial Hypercholesterolemia (HoFH) – Pipeline by Gemphire Therapeutics Inc, H2 2016 15

Homozygous Familial Hypercholesterolemia (HoFH) – Pipeline by LipimetiX Development Inc, H2 2016 16

Homozygous Familial Hypercholesterolemia (HoFH) – Pipeline by Regeneron Pharmaceuticals Inc, H2 2016 17

Homozygous Familial Hypercholesterolemia (HoFH) – Pipeline by RegenxBio Inc, H2 2016 18

Assessment by Monotherapy Products, H2 2016 19

Number of Products by Stage and Target, H2 2016 21

Number of Products by Stage and Mechanism of Action, H2 2016 23

Number of Products by Stage and Route of Administration, H2 2016 25

Number of Products by Stage and Molecule Type, H2 2016 27

Homozygous Familial Hypercholesterolemia (HoFH) – Dormant Projects, H2 2016 47

List of Figures

List of Figures

Number of Products under Development for Homozygous Familial Hypercholesterolemia (HoFH), H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Clinical Stage Development, H2 2016 10

Comparative Analysis by Early Stage Products, H2 2016 11

Assessment by Monotherapy Products, H2 2016 19

Number of Products by Targets, H2 2016 20

Number of Products by Stage and Targets, H2 2016 20

Number of Products by Mechanism of Actions, H2 2016 22

Number of Products by Stage and Mechanism of Actions, H2 2016 22

Number of Products by Routes of Administration, H2 2016 24

Number of Products by Stage and Routes of Administration, H2 2016 24

Number of Products by Molecule Types, H2 2016 26

Number of Products by Stage and Molecule Types, H2 2016 26

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