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

February 5, 2018

Company Drug/Device Medical Condition Status
Immuron IMM-529 Clostridium Difficile Infection Phase I/II trials initiated enrolling 60 subjects
SillaJen pexastimogene devacirepvec (Pexa-Vec) metastatic colon cancer Phase I/II trials initiated
Mapi Pharma GA Depot primary progressive multiple sclerosis Phase II trials initiated enrolling 12-24 subjects
Merus MCLA-128 metastatic breast cancer Phase II trials initiated enrolling 120 subjects in the U.S. and Europe
Novan SB206 molluscum contagiosum Phase II trials initiated enrolling 192 children and adolescents
Aldeyra Therapeutics topical ocular reproxalap dry eye disease Phase IIb trials initiated enrolling 300 subjects
Dermira lebrikizumab moderate to severe atopic dermatitis Phase IIb trials initiated enrolling 350 subjects in the U.S.
BeiGene tislelizumab advanced unresectable or metastatic esophageal squamous cell carcinoma Phase III trials initiated enrolling 350 subjects globally
Cara Therapeutics Korsuva (CR845/difelikefalin) hemodialysis patients suffering from moderate to severe chronic kidney disease-associated pruritus Phase III trials initiated enrolling 350 subjects in the U.S.
Diffusion Pharmaceuticals trans sodium crocetinate newly-diagnosed inoperable glioblastoma multiforme Phase III trials initiated enrolling 264 subjects
Aquestive Therapeutics Riluzole Oral Soluble Film amyotrophic lateral sclerosis Orphan Drug designation granted by the FDA
Dauntless Pharmaceuticals DP1038 acromegaly Orphan Drug designation granted by the FDA
Ensysce Biosciences PF614 moderate to severe chronic pain Fast Track designation granted by the FDA
Faron Pharmaceuticals Traumakine acute respiratory distress syndrome Fast Track designation granted by the FDA
Protalix Biotherapeutics PRX-102 Fabry disease Fast Track designation granted by the FDA
Synthon [vic-]trastuzumab duocarmazine (SYD985) HER2-positive metastatic breast cancer Fast Track designation granted by the FDA
Takeda Pharmaceutical TAK-426 Zika virus vaccine Fast Track designation granted by the FDA
LimFlow LimFlow Percutaneous Deep Vein Arterialization System end-stage critical limb ischemia Breakthrough Device designation granted by the FDA
Roche balovaptan autism spectrum disorder Breakthrough Therapy Designation granted by the FDA
AngioDynamics NanoKnife System stage III pancreatic cancer Expedited Access Pathway designation granted by the FDA
Abeona Therapeutics EB-101 recessive dystrophic epidermolysis bullosa Regenerative Medicine Advanced Therapy designation granted by the FDA
CutisPharma CutisPharma Firvanq (vancomycin hydrochloride) Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus FDA approved
Synergy Pharmaceuticals Trulance (plecanatide) irritable bowel syndrome with constipation FDA approved