US biotechnology company Xoma has presented data from two early-stage trials which suggests that one of its experimental antibodies can offer “a novel anti-inflammatory approach to type 2 diabetes treatment that may preserve insulin-producing cells”.

The results, which were presented at the European Association for the Study of Diabetes in Rome, involve XOMA 052, which targets interleukin-1 beta, a master signalling protein which triggers inflammatory pathways in the body. The company said that the drug demonstrated biological activity in two single-dose, dose-escalation, Phase I studies involving 48 patients from five groups in a US study and three dose groups in a European study.

Xoma noted that although the number of patients in each dose group was limited, median HbA1c levels, the standard measure of glucose control, were reduced in all five groups and the reduction was as much as 0.6% at 28 days. A single dose of XOMA 052 reduced median HbA1c in four of the five drug dose levels compared to placebo.

Marc Donath of the University Hospital of Zurich and European clinical trial principal investigator, said that bearing in mind that HbA1c reflects average blood glucose over a three-month period, “these levels of early reduction are particularly encouraging.'' He added that if the inhibition of IL-1 beta improves the condition of insulin-producing cells in diabetes patients by targeting inflammation, “the implications would be very promising for the treatment of the disease” and suggest that XOMA 052 “may address this fundamental and still largely unexplored inflammatory pathway and warrants continued clinical investigation.''

Alan Solinger, Xoma's vice president of clinical immunology, said that current approaches “force more insulin out of 'tired' pancreatic beta cells or make peripheral cells more sensitive to insulin, whereas XOMA 052 targets inflammation – a newly recognised mechanism”. He added that showing an increase in insulin production three months after a single infusion “is remarkable” and “if these increases are confirmed in larger studies, we could have a disease-modifying therapy”.'

Chief executive Steven Engle, added that “it is very exciting to see that a single dose of XOMA 052 had such positive biological activity and duration of effect, and was well tolerated''. Saying that “clearly, the results exceeded our expectations for a Phase I study”, he acknowledged that although the numbers of patients were limited and more studies are needed, “the potency demonstrated to date is compelling”.

Mr Engle concluded by noting that “we are encouraged not only to proceed with additional studies in diabetes but also to expand our clinical development of XOMA 052 in other indications such as rheumatoid arthritis, acute gout and systemic juvenile idiopathic arthritis”.'