Date: 2017-01-31
Type of information: Results
phase: 2
Announcement: results
Company: Xoma (USA - CA)
Product: XOMA 358
Action
mechanism: monoclonal antibody. XOMA 358 is a fully human allosteric modulating monoclonal antibody that binds to insulin receptors and attenuates insulin action. XOMA 358 is being investigated as a novel treatment for non-drug-induced, endogenous hyperinsulinemic hypoglycemia (low blood glucose caused by excessive insulin production) and other related disorders.
Disease: patients who experience hypoglycemia after undergoing gastric bypass surgery
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On January 31, 2017, Xoma announced that it has established proof-of-concept for its product candidate 358 in hypoglycemia post-bariatric surgery (PBS). Open-label, Phase 2 study evaluated 358 in 13 patients with hypoglycemia post-bariatric surgery (PBS). The study was performed with expert disease centers in Denver, Baltimore, Boston, and Rochester, Minnesota. The Phase 2 study was monitored for safety, and serial blood samples were collected for pharmacokinetic and pharmacodynamic assessments. Various markers of drug activity were assessed, including changes in glucose, ketones, insulin, C-peptide and free fatty acid levels. Controlled tests included monitored fasts, protein challenges, and oral glucose tolerance. The PBS study has completed dosing in the single-dose cohorts and has met its objectives; a multi-dose study has been initiated. * On April 27, 2016, Xoma announced it has initiated its proof-of-concept study to evaluate the safety and clinical pharmacology of a single dose of XOMA 358 in patients who experience dangerously low blood glucose levels (hypoglycemia) after undergoing gastric bypass surgery. The open-label, single-dose, multi-center study, in which patients serve as their own control, is designed to evaluate ascending dose levels of XOMA 358 in patients with documented hypoglycemia after gastric bypass surgery. This is a cohort study, with the first cohort receiving a dose of XOMA 358 chosen based on the safety and pharmacodynamics results from XOMA's Phase 1 study in healthy subjects. Subsequent cohorts may receive a higher or lower dose dependent on the results seen in the first cohort. The study will document consistent hypoglycemic events prior to treatment with XOMA 358 and the ability of XOMA 358 to prevent these events after dosing. Safety will be monitored throughout the study. In addition, serial blood samples will be collected for pharmacokinetic and pharmacodynamic assessments. Various markers of drug activity will be assessed, including changes in glucose, ketones, insulin, C-peptide and free fatty acid levels. Additional measurements of biological effect will include protein challenges and continuous glucose monitoring.
