Date: 2015-03-07
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the Endocrine Society\'s Annual Meeting - ENDO 2015
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. A therapy that safely and effectively mitigates insulin-induced hypoglycemia has the potential to address a significant unmet therapeutic need for certain rare medical conditions associated with hyperinsulinism.
Disease: hyperinsulinemic hypoglycemia
Therapeutic area: Rare diseases - Endocrinological diseases - Metabolic diseases
Country:
Trial details:
Latest
news: * On March 7, 2015, Xoma announced the presentation of data from XOMA 358, the lead antibody in the Company\'s XMet D program, at the Endocrine Society\'s Annual Meeting - ENDO 2015. Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer at XOMA, presented the Company\'s data, titled "XOMA 358, a Novel Treatment for Hyperinsulinemic Hypoglycemia: Safety and Clinical Pharmacology from the First in Human Trial". The Phase 1 first-in-human study enrolled 19 healthy volunteer subjects; 14 received XOMA 358 and 5 received placebo. Individual cohorts were administered XOMA 358 doses of 0.1, 0.3, 1, and 3 mg/kg or placebo, with dose escalation based on review of safety and pharmacokinetic data from each cohort. Changes in insulin and glucose were monitored through the use of Mixed meal tests (MMTs) and insulin tolerance tests (ITT). Dose-related increases in post-prandial (after eating a meal) glucose levels, consistent with down-regulation of insulin signaling, were observed through Day 6 following drug infusion, with the Day 3 glucose AUC nearly 80% greater than placebo at the 1 mg/kg dose level. Fasting HOMA-IR values, a measure of reduced insulin signaling, were likewise elevated in a dose-dependent manner and, at peak time points, were several fold over baseline. Subjects who were given a single administration of XOMA 358 at 3 mg/kg were infused with insulin before and 2, 3 and 5 days after dosing. Prior to administration of the drug, as expected, the infusion caused a significant lowering of blood sugar. This lowering of blood sugar was significantly blunted at all subsequent time points tested. These preliminary data provide a strong rationale for continued study of XOMA 358 in adults and children with hypoglycemia due to overproduction of insulin. XOMA 358 appeared to be well-tolerated; there were no serious adverse events.
