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: congenital hyperinsulinism
Therapeutic area: Rare diseases - Hormonal diseases - Endocrine diseases - Genetic diseases
Country: USA
Trial details:
Latest
news: * On January 31, 2017, Xoma announced that it has established proof-of-concept for its product candidate 358 in congenital hyperinsulinism (CHI). The CHI acute studies have met their objectives of establishing initial safety and 358 proof-of-concept in CHI patients aged 12 and up across several dosing levels. Xoma is nearing the launch of a multi-dose study in children with CHI aged 2 and up that will be conducted in the United Kingdom. Open-label, Phase 2 studi evaluated 358 in 14 patients with congenital hyperinsulinism (CHI). The study was performed with expert disease centers in Philadelphia, Magdeburg, Germany, and London. * On October 26, 2015, Xoma announced it has initiated a Phase 2 proof-of-concept study to evaluate the safety and ability to prevent hypoglycemia (dangerously low blood sugar) of a single dose of XOMA 358 in patients with congenital hyperinsulinism (HI). Congenital hyperinsulinism is a genetic disorder in which the beta cells of the pancreas secrete excessive insulin that causes hypoglycemia, which can lead to brain damage or, in rare cases, death. The FDA granted Orphan Drug Designation to XOMA 358 for the treatment of this rare disease. The open-label, single-administration study will evaluate XOMA 358 in congenital hyperinsulinism patients with documented hypoglycemia after a prolonged fast. Two cohorts of patients are planned, with the first cohort receiving a dose of XOMA 358 chosen based on the results from XOMA's Phase 1 study in healthy subjects. The second cohort of patients may receive a higher or lower dose dependent on the results seen in cohort 1. Patients will serve as their own control. The study will attempt to provoke and document hypoglycemic events due to fasting challenges prior to treatment with XOMA 358. Patients who experience hypoglycemia will be treated with XOMA 358 and then rechallenged by fasting at predetermined points in time to measure the potential impact and durability of XOMA 358 on hypoglycemia.The study is open for patient enrollment at the Children's Hospital of Philadelphia (CHOP) and an additional international site is expected to open in the near-term. 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. Controlled tests include monitored fasts, protein challenges, and oral glucose tolerance.
