Xoma has initiated a second Phase I study of its monoclonal antibody targeting interleukin-1 beta, in patients with type 2 diabetes.
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The Europe-based study, designed to assess the safety and pharmacokinetics of Xoma 052, will enroll up to 36 subjects with type 2 diabetes and includes disease-specific outcome measurements. The trial will also strengthen Xoma’s involvement with the European researchers and institutions specialized in the investigation of the IL-1 disease pathway in diabetes.
Marc Donath, professor at the University Hospital of Zurich, is the study’s principal investigator.
The US-based trial is currently ongoing. The company expects to use the safety data from the two Phase I studies to guide the development of Xoma 052 in type 2 diabetes and to evaluate its relevance for other inflammatory indications, which may include rheumatoid arthritis, systemic juvenile idiopathic arthritis and osteoarthritis.
Alan Solinger, vice president of clinical immunology, said: “We are optimistic about the therapeutic potential of Xoma 052 for use in the treatment of multiple inflammatory diseases. The importance of the IL-1 pathway for rheumatoid arthritis is already well documented in humans.”
Steven Engle, CEO and president, added: “We are excited by the potential of Xoma 052 to address a number of chronic diseases with major unmet medical needs, and look forward to evaluating options for its broader clinical development. This novel, high-affinity antibody addresses a disease pathway where the pathogenic impact of the pathway and beneficial effect of intervention have been demonstrated in humans.”
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