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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

Eighteen Drugs and Devices have Entered a New Trial Phase This Week

February 12, 2018

Company Drug/Device Medical Condition Status
Fibrocell Science FCX-013 moderate to severe localized scleroderma IND submitted to the FDA
Daiichi Sankyo U3-1402 metastatic or unresectable epidermal growth factor receptor-mutated non-small cell lung cancer Phase I trials initiated enrolling 60 subjects globally
Palatin Technologies PL-8177 ulcerative colitis and other inflammatory bowel diseases Phase I trials initiated enrolling 52 subjects
Phosplatin Therapeutics PT-112 relapsed or refractory multiple myeloma Phase I/II trials initiated
Gemphire gemcabene pediatric nonalcoholic fatty liver disease Phase IIa trials initiated enrolling 40 adolescent children between the ages of 12 and 17
OncBioMune Pharmaceuticals ProscaVax advanced prostate cancer Phase II trials initiated
Xcovery ensartinib (X-396) advanced malignant melanoma harboring alterations in ALK Phase II trials initiated
Endo International collagenase clostridium histolyticum cellulite Phase III trials initiated enrolling 840 women in the U.S.
Pharma Two B P2B001 early Parkinson’s disease Phase III trials initiated enrolling 525 subjects
Tessa Therapeutics T cell immunotherapy nasopharyngeal cancer Phase III trials initiated enrolling 35 subjects
GlaxoSmithKline Bexsero meningitis B vaccine Breakthrough Therapy designation granted by the FDA
Sage Therapeutics SAGE-217 major depressive disorder Breakthrough Therapy designation granted by the FDA
Zogenix ZX008 (low-dose fenfluramine) seizures associated with Dravet syndrome Breakthrough Therapy designation granted by the FDA
MeiraGTx AAV2/8-hCARp.hCNGB3 (A002) achromatopsia due to mutations in the CNGB3 gene Rare Pediatric Disease designation granted by the FDA
Adhesys Medical VIVO surgical sealant Expedited Access Pathway designation granted by the FDA
Alnylam Pharmaceuticals patisiran hereditary ATTR amyloidosis NDA accepted and Priority Review granted by the FDA
Allergan Avycaz (ceftazidime and avibactam) hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia Expanded use approved by the FDA
Ferring Pharmaceuticals Zomacton (somatropin) human growth hormone deficiency FDA approved

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

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

January 29, 2018

Company Drug/Device Medical Condition Status
Apexian Pharmaceuticals APX3330 advanced solid tumors Phase I trials initiated
Bavarian Nordic BN-Brachyury cancer metastasis Phase I trials initiated enrolling 10 subjects
Protalex PRTX-100 (PRTX-100-203 Study) persistent/chronic Immune Thrombocytopenia Phase Ib trials initiated enrolling 30 subjects in Europe
IntelGenx Montelukast VersaFilm Alzheimer’s disease Phase IIa trials initiated
Biomarck Pharmaceutical BIO-11006 non-small cell lung cancer Phase II trials initiated in India
Melinta Therapeutics radezolid bacterial vaginosis Phase II trials initiated
TrovaGene PCM-075 + Zytiga metastatic castration-resistant prostate cancer Phase II trials initiated enrolling 25 subjects
Evofem Biosciences Amphora prevention of urogenital chlamydia and gonorrhea in women Phase IIb/III trials initiated enrolling 850 subjects in the U.S.
GC Pharma GC1102 hepatitis B virus infection following liver transplantation Phase II/III trials planned
Swedish Orphan Biovitrum SOBI003 mucopolysaccharidosis type IIIA Fast Track designation granted by the FDA
Astellas Pharma gilteritinib acute myeloid leukemia Orphan Drug designation granted by the EC
BERG BPM31510 pancreatic cancer Orphan Drug designation granted by the FDA
Enzychem Lifesciences EC-18 acute radiation syndrome Orphan Drug designation granted by the FDA
Nohla Therapeutics NLA101 hematopoietic stem cell transplantation Orphan Drug designation granted by the EC
Omeros OMS721 primary Immunoglobulin A nephropathy Orphan Drug designation granted by the EMA
Orphazyme arimoclomol Niemann-Pick disease Type C Rare Pediatric Disease designation granted by the FDA
Genmab daratumumab (Darzalex) + bortezomib, melphalan and prednisone newly diagnosed multiple myeloma Priority Review granted by the FDA
Baxter International Bivalirudin anticoagulant in patients undergoing percutaneous coronary intervention FDA approved
Bristol-Myers Squibb Yervoy (ipilimumab) advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older EC expanded indication approved
Takeda Pharmaceutical Adcetris (brentuximab vedotin) CD30-positive cutaneous T-cell lymphoma EC extended current conditional marketing authorization

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

January 22, 2018

Company Drug/Device Medical Condition Status
Tetra Bio-Pharma PPP005 safety study Phase I trials planned in Canada
Constellation Pharmaceuticals CPI-1205 oncology Phase Ib/II trials initiated
CytRx Aldoxorubicin metastatic pancreatic cancer Phase Ib/II trials initiated enrolling 173 subjects
Transgene TG4010 MUC1 expressing tumors Phase II trials initiated enrolling 39 subjects
Ophthotech Zimura (avacincaptad pegol) autosomal recessive Stargardt disease (STGD1) Phase IIb trials initiated enrolling 120 subjects
MiMedx AmnioFix Injectable recalcitrant plantar fasciitis pain Phase III trials initiated enrolling 164 subjects
LivaNova Aortic Valve Implant reporting of reduced leaflet motion Post-Market trials initiated enrolling 230 subjects in the U.S. and Canada
Aspyrian Therapeutics RM-1929 locoregional recurrent head and neck squamous cell carcinoma Fast Track designation granted by the FDA
Centrexion CNTX-4975 pain associated with knee osteoarthritis Fast Track designation granted by the FDA
Concert Pharmaceuticals CTP-543 moderate to severe alopecia areata Fast Track designation granted by the FDA
Cour Pharmaceuticals TIMP-GLIA Celiac disease Fast Track designation granted by the FDA
Benitec BioPharma BB-301 oculopharyngeal muscular dystrophy Orphan Drug designation granted by the FDA
Helsinn, MEI Pharma pracinostat acute myeloid leukemia Orphan Drug designation granted by the EMA
Novartis Kymriah (tisagenlecleucel) relapsed or refractory diffuse large B-cell lymphoma Priority Review granted by the FDA, Accelerated Assessment granted by the EMA
ACON Laboratories, Innovus Pharma UriVarx Urinary Tract Infection test strips overactive bladder, urinary incontinence FDA administration clearance
AstraZeneca, Merck Lynparza (olaparib) deleterious or suspected deleterious gBRCAm HER2-negative metastatic breast cancer FDA approved
Avion Pharmaceuticals Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) oral contraceptive FDA approved
Boehringer Ingelheim Gilotrif (afatinib) metastatic non-small cell lung cancer with non-resistant EGFR mutations FDA approved
GlaxoSmithKline Fluarix Quadrivalent (Influenza Vaccine) flu in patients 3 years of age or older FDA expanded indication approved
Innovus Pharma Xyralid (DIN 02471434) pain and symptom relief for hemorrhoids Health Canada approved
Myriad Genetics BRACAnalysis CDx HER2-negative metastatic breast cancer with germline BRCA mutation FDA approved

Fifteen drugs and devices have entered a new trial phase this week

January 15, 2018

Company Drug/Device Medical Condition Status
Chimerix brincidofovir adenovirus infection related to pediatric transplant Phase I trials initiated in 141 subjects in the U.S. and Europe
Oncolix Prolanta advanced ovarian cancer Phase I trials initiated
Immix Biopharma IMX-110 advanced Solid Tumors Phase I/IIa trials planned
Aptevo Therapeutics otlertuzumab peripheral T-cell lymphoma Phase II trials initiated enrolling 24 subjects
Novaliq NOV03 dry eye disease Phase II trials initiated
Akcea Therapeutics AKCEA-APOCIII-LRx hypertriglyceridemia, established cardiovascular disease Phase IIb trials initiated
CymaBay Therapeutics seladelpar primary biliary cholangitis Phase II/III trials initiated
Minoryx Therapeutics MIN-102 adrenomyeloneuropathy Phase II/III trials initiated globally
Semnur Pharmaceuticals SP-102 lumbar radicular pain/sciatica Phase III trials initiated enrolling 400 subjects in the U.S.
Semnur Pharmaceuticals SP-102 lumbar radicular pain/sciatica Fast Track designation granted by the FDA
Avadel Pharma FT 218 narcolepsy Orphan Drug designation granted by the FDA
Spruce Biosciences SPR001 congenital adrenal hyperplasia Orphan Drug designation granted by the EMA
AbbVie upadacitinib (ABT-494) moderate to severe atopic dermatitis Breakthrough Therapy designation granted by the FDA
Global Blood Therapeutics voxelotor sickle cell disease Breakthrough Therapy designation granted by the FDA
Amgen Xgeva (denosumab) prevention of skeletal-related events in patients with multiple myeloma FDA expanded approval