|Cytodyn Inc., of Vancouver, Wash.||Leronlimab (PRO-140)||CCR5 antagonist||Metastatic triple-negative breast cancer||Further data from first patient in phase Ib/II trial continue to show no detectable circulating tumor cells (CTC) or putative metastatic tumor cells in peripheral blood and additional reductions in CCR5 expression on cancer-associated cells at 11 weeks of treatment; additional data in an emergency IND protocol involving 1 metastatic breast cancer patient demonstrated shrinkage of tumor (via MRI) after 3 weeks of treatment|
|Trevena Inc., of Chesterbrook, Pa.||TRV-734||Mu-opioid receptor selective agonist||Opioid use disorder||Initiated proof-of-concept study funded by National Institute on Drug Abuse; study will enroll about 50 opioid-dependent patients undergoing stable methadone maintenance therapy; primary objective is to assess ability of drug to reduce acute opioid craving symptoms, as measured by Subjective Opioid Withdrawal Scale|
|Akari Therapeutics plc, of New York||Nomacopan||C5 complement inhibitor||Hematopoietic stem cell transplant-related thrombotic microangiopathy||IND open; study to start in the first quarter of 2020; part A is a dose-confirmation study; part B is a single-arm responder-based efficacy study|
|Phathom Pharmaceuticals Inc., of Buffalo Grove, Ill.||Vonoprazan||Potassium competitive acid blocker||H. pylori infection||Initiated pivotal Phalcon-HP trial to evaluate vonoprazan in combination with amoxicillin (vonoprazan dual therapy) and vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy); primary endpoint is the percentage of patients with successful eradication of H. pylori infection|
|Progenics Pharmaceuticals Inc., of New York||PyL||PSMA-targeted PET imaging agent||Prostate cancer||Condor study met its primary endpoint with a correct localization rate of 84.8% to 87% among the 3 blinded independent readers|
For more information about individual companies and/or products, see Cortellis.