XOMA Corp (NASDAQ:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today 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. XOMA 358 is a fully human allosteric monoclonal antibody that reduces both the binding of insulin to its receptor and downstream insulin signaling.
“Significant numbers of morbidly obese patients have turned to gastric bypass surgery as a critical healthcare intervention,” said Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer at XOMA. “Unfortunately, some of these bypass surgery patients can develop a condition where they experience severe hypoglycemia after eating a meal. In some cases, this severe hypoglycemia cannot be managed by diet modification or resolved by existing pharmacologic agents, requiring patients to be treated with either a reversal of the bypass procedure or even a partial pancreatectomy. This clinical study will determine if XOMA 358 could be developed further as a first-in-class medical alternative for the treatment of severe hyperinsulinemic hypoglycemia in post gastric bypass patients.”
Proof-of-Concept Study Design
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. (Original Source)
Shares of XOMA closed yesterday at $0.90, down $0.01 or -0.65%. XOMA has a 1-year high of $4.93 and a 1-year low of $0.69. The stock’s 50-day moving average is $0.83 and its 200-day moving average is $1.07.
On the ratings front, XOMA has been the subject of a number of recent research reports. In a report issued on March 11, Wedbush analyst Liana Moussatos reiterated a Buy rating on XOMA, with a price target of $3, which implies an upside of 231.9% from current levels. Separately, on March 10, Piper Jaffray’s Edward Tenthoff maintained a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Liana Moussatos and Edward Tenthoff have a total average return of 8.6% and -2.7% respectively. Moussatos has a success rate of 37.2% and is ranked #314 out of 3829 analysts, while Tenthoff has a success rate of 37.8% and is ranked #3289.
XOMA Corp. is a development stage biotechnology company. It engages in the provision of discovering and developing antibody-based therapeutics. The company was founded by Patrick J. Scannon in 1981 and is headquartered in Berkeley, CA.