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Twenty-one Drugs and Devices have Entered a New Trial Phase This Week

February 19, 2018

Company Drug/Device Medical Condition Status
Applied Therapeutics AT-001 diabetic complications Phase I trials initiated
Aravive Biologics AVB-S6-500 n/a Phase I trials initiated enrolling 40 subjects in the U.S.
Mallinckrodt ExpressGraftC9T1 skin tissue diabetic foot ulcers Phase I trials initiated enrolling six subjects
Pulmatrix Pulmazole (PUR1900) allergic bronchopulmonary aspergillosis related to asthma Phase I trials initiated enrolling 42 subjects
Vyera Pharmaceuticals TUR-006 toxoplasmosis Phase I trials initiated
MyoKardia MYK-491 dilated cardiomyopathy Phase Ib trials initiated enrolling 64 subjects
Arrowhead Pharmaceuticals ARO-HBV chronic hepatitis B virus infection Phase I/II trials planned enrolling 30 subjects in New Zealand
Audentes Therapeutics AT342 Crigler-Najjar syndrome Phase I/II trials initiated
Sienna Biopharmaceuticals SNA-125 psoriasis and the associated pruritus Phase I trials initiated enrolling 15 subjects
Imara IMR-687 sickle cell disease Phase IIa trials initiated enrolling 50 subjects in the U.S.
Nohla Therapeutics NLA101 acute myeloid leukemia Phase II trials initiated enrolling 220 subjects in the U.S.
Citius Pharmaceuticals, Inc. Mino-Lok Therapy catheter related bacteremias Phase III trials initiated enrolling 700 subjects in the U.S.
Intercept Pharmaceuticals obeticholic acid cirrhosis due to NASH Phase III trials planned enrolling 540 subjects
Pfizer PF-04965842 moderate to severe atopic dermatitis Breakthrough Therapy designation granted by the FDA
Abeona Therapeutics ABO-202 infantile Batten disease Orphan Drug designation granted by the FDA
AstraZeneca, Merck selumetinib neurofibromatosis type 1 Orphan Drug designation granted by the FDA
Xeris Pharmaceuticals ready-to-use glucagon Hyperinsulinemic Hypoglycemia Orphan Drug designation granted by the FDA
60 Degrees Pharmaceuticals Tafenoquine prevention of malaria Priority Review designation granted by the FDA
Genentech Rituxan (rituximab) pemphigus vulgaris Priority Review designation granted by the FDA
Janssen Erleada (apalutamide) non-metastatic castration-resistant prostate cancer FDA approved
NorthStar Medical Radioisotopes RadioGenix System Non-uranium Sourced Molybdenum-99 Production of Imaging Isotope Technetium-99m FDA approved