Pipeline

December 22, 2019

Company	Drug/Device	Medical Condition	Status
Meiji Seika Pharma Co.	DMB-3115	plaque psoriasis	Phase 1 trial initiated in healthy subjects at one site in Europe
Alligator Bioscience	ATOR-1017	cancer	Phase 1 trial initiated dosing 50 subjects at three sites in Sweden
MODAG	anle138b	multiple system atrophy and Parkinson’s disease	Phase 1 trial initiated enrolling healthy subjects
Chondrial Therapeutics	CTI-1601	Friedreich’s Ataxia	Phase 1 trial initiated dosing adult subjects over the age of 18 with Friedreich’s Ataxia
NeuClone Pharmaceuticals	ustekinumab	psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis	Phase 1 trial initiated dosing 210 subjects
Arcus Biosciences Genentech	AB928, regorafenib, and atezolizumab	colorectal and pancreatic cancer	Phase 1/1b trial initiated in subjects with breast or ovarian cancer, gastroesophageal or colorectal cancer, lung cancer and advanced malignancies
OBI Pharma	OBI-999	cancer	Phase 1/2 trial initiated enrolling subjects with solid tumors including gastric, pancreatic, colorectal and esophageal cancer at the University of Texas MD Anderson Cancer Center in Houston, Texas
Zentalis Pharmaceuticals	ZN-c3	cancer	Phase 1/2 trial initiated dosing two subjects with advanced solid tumors
Akero Therapeutics	AKR-001	non-alcoholic steatohepatitis	Phase 2 trial initiated enrolled 80 subjects with non-alcoholic steatohepatitis at multiple centers
DiaMedica Therapeutics	DM199	chronic kidney disease	Phase 2 trial initiated dosing 60 African American subjects with hypertension and chronic kidney disease with IgA nephropathy
Catabasis Pharmaceuticals	edasalonexent	Duchenne muscular dystrophy	Phase 3 trial initiated enrolled 131 boys affected by Duchenne muscular dystrophy ages 4 to 7 with any mutation type whom had not been on steroids for the previous six months at 37 sites in the United States, Canada, Europe, Israel and Australia
Kamada	inhaled Alpha-1 Antitrypsin	Alpha-1 Antitrypsin Deficiency	Phase 3 trial initiated enrolling 250 subjects with AATD and moderate lung disease
Avadel Pharmaceuticals	FT218	Narcolepsy	Phase 3 trial initiated enrolled 212 subjects with narcolepsy
Mycovia Pharmaceuticals	VT-1161	recurrent vulvovaginal candidiasis	Phase 3 trial initiated enrolling 200 subjects with recurrent vulvovaginal candidiasis at 51 sites in the U.S.
Calliditas Therapeutics	Nefecon	IgA nephropathy	Phase 3 trial initiated enrolling 200 subjects with IgAN at approximately 140 sites in 19 countries
Innovation Pharmaceuticals	Brilacidin	ulcerative colitis	Clinical Trial Authorization acceptance granted by the MHRA
Pfizer	encorafenib in combination with cetuximab	colorectal cancer	sNDA granted by the FDA
ITF Pharma	TIGLUTIK	Amyotrophic Lateral Sclerosis	sNDA granted by the FDA
Amneal Pharmaceuticals	EluRyng	generic version of NuvaRing	aNDA granted by the FDA
Daré Bioscience	DARE-BV1	bacterial vaginosis	IND approval granted by the FDA
Zentalis Pharmaceuticals	ZN-c3	cancer	IND Approval granted by the FDA
Chondrial Therapeutics	CTI-1601	Friedreich’s Ataxia	Fast-Track Designation and Rare Pediatric Disease Designation granted by the FDA
Salarius Pharmaceuticals	seclidemstat	Ewing sarcoma	Fast Track Designation granted by the FDA
Boston Scientific	EXALT Model D	single-use duodenoscope	Clearance granted by the FDA
Amarin Pharma	Vascepa	cardiovascular events	FDA approval granted
Pfizer	Xeljanz	ulcerative colitis	Approval granted by the FDA