Pipeline

April 2, 2018

Company	Drug/Device	Medical Condition	Status
GT Biopharma Inc.	GTP-004	myasthenia gravis	Phase I trials initiated
LivaNova PLC	Perceval sutureless aortic heart valve	diseased native or malfunctioning prosthetic aortic valve	Phase I trials initiated enrolling 160 subjects in China
Five Prime Therapeutics, Inc.	FPA150	B7-H4 expression observed in multiple solid tumors, including breast, bladder and gynecologic cancers	Phase I trials initiated
vTv Therapeutics Inc.	TTP399	type 1 diabetes	Phase Ib trials initiated
Allecra Therapeutics	AAI101	complicated urinary tract infections (cUTIs)	Phase II trials initiated
Flex Pharma Inc.	FLX-787	multiple sclerosis	Phase II trials initiated enrolling 57 subjects
Eiger Biopharmaceuticals, Inc.	exendin 9-39	post-bariatric hypoglycemia (PBH)	Phase II trials initiated enrolling 36 subjects
ProMetic Life Sciences Inc.	PBI-4050	Alström syndrome	Phase II trials initiated enrolling 12 subjects
MiMedx Group, Inc.	AminoFix Injectable	Plantar Fasciitis	Phase IIb trials initiated enrolling 145 subjects
MiMedx Group, Inc.	AminoFix Injectable	Osteoarthritis (OA) of the knee	Phase IIb trials initiated enrolling 318 subjects
BrainStorm Cell Therapeutics Inc.	NurOwn	amyotrophic lateral sclerosis (ALS)	Phase III trials initiated enrolling subjects from Canada
Urovant Sciences	vibegron	overactive bladder	Phase III trials initiated enrolling 1,400 subjects

Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Pipeline