Company Product Description Indication Status
Phase I
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
Phase III
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

Notes

For more information about individual companies and/or products, see Cortellis.

No Comments