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New Pipeline Updates from Concert, Spiral and Daiichi Sankyo

December 31, 2018

Company Drug/Device Medical Condition Status
Concert Pharmaceuticals CTP-692 schizophrenia Phase I trial initiated enrolling 80 healthy volunteers
Spiral Therapeutics LPT99 inner ear disorders Phase I trial initiated enrolling 32 healthy adult subjects
Daiichi Sankyo Company, Ltd. quizartinib, a FLT3 inhibitor and an MDM2 inhibitor, milademetan (DS-3032) relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) or newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy Phase I trial initiated enrolling up to 110 subjects in the U.S., EU and Japan
Carmot Therapeutics CT-868 type 2 diabetes Phase I trial initiated enrolling overweight or obese but otherwise healthy volunteers and subjects
Viriom, Inc. VM1500A once monthly injectable HIV Phase I trial initiated enrolling up to 36 HIV-uninfected volunteers in Moscow, Russia
CStone Pharmaceuticals CS1001 advanced solid tumors Phase I trial initiated enrolling subjects in the U.S.
MiNATherapeutics MTL-CEBPA in combination with Sorafenib advanced liver cancer Phase Ib trial initiated enrolling 38 subjects in the U.K., Singapore and Taiwan
Actuate Therapeutics, Inc. 9-ING-41 refractory hematologic malignancies or solid tumors Phase I/II trial initiated
Vedanta Biosciences VE303 recurrent Clostridium difficile infection (rCDI) Phase II trial initiated enrolling up to 146 subjects with a recent diagnosis of rCDI
Hookipa Pharma, Inc. HB-101 cytomegalovirus (CMV) Phase II trial initiated enrolling 150 male and female subjects aged 18 years or older at 35 sites worldwide
Pear Therapeutics, Inc. Pear-004 schizophrenia Phase II trial initiated
Ayala Pharmaceuticals, Inc. AL101 adenoid cystic carcinoma (ACC) bearing Notch activated mutations Phase II trial initiated enrolling subjects at eight sites in the U.S.
Isofol Medical AB arfolitixorin metastatic colorectal cancer (mCRC) Phase III trial initiated enrolling 440 subjects aged 18 years or older
Corbus Pharmaceutical Holdings, Inc. lenabasum dermatomyositis Phase III trial initiated enrolling 150 subjects
Rakuten Aspyrian ASP-1929 recurrent local regional head and neck squamous cell carcinomas (HNSCC) Phase III trial initiated enrolling 275 subjects at 75 sites in the U.S., Europe and Asia
CathWorks FFRangio System multi-vessel coronary artery disease 510(k) clearance granted by the FDA
Retia Medical, LLC Argos Cardiac Output (CO) Monitor cardiac output monitoring 510(k) clearance granted by the FDA
Arch Therapeutics, Inc. AC5 Topical Gel partial and full-thickness wounds 510(k) clearance granted by the FDA
Amgen Nplate (romiplostim) immune thrombocytopenia (ITP) sBLA approval granted by the FDA