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Xoma, Servier diabetes drug fails trial

A potential therapy for diabetes being developed by the biotech company Xoma in partnership with the French pharma firm Servier failed to meet the primary endpoint in a phase IIb study

A potential therapy for diabetes being developed by the biotech company Xoma in partnership with the French pharma firm Servier failed to meet the primary endpoint in a phase IIb study.

The therapy, a monoclonal antibody known as Xoma 052, did not sufficiently reduce glycosylated haemoglobin, or HbA1c, in type II diabetes patients in the placebo-controlled study.

However, the study data did support Xoma 052's potential to cut the risk of cardiovascular disease by decreasing C-reactive protein, according to the company. Xoma 052 also produced statistically significant improvements in high-density lipoprotein in two out of four dose groups treated with the drug. The therapy was well-tolerated, with no serious drug-related adverse events.

The six-month study enrolled 421 patients who had type 2 diabetes and were receiving metformin monotherapy. Patients were randomised to receive one of four Xoma 052 doses or placebo by subcutaneous administration each month.

The development partners said they would work together to determine next steps for the diabetes indication pending completion of an ongoing phase IIa study and a full analysis of data from both trials.

The companies also intend to go forward with programmes for the drug in other indications, including a phase III programme in Behcet's uveitis that Xoma hopes to begin later this year. The condition is a rare and sometimes fatal disease characterised by oral and genital ulcers as well as potential musculoskeletal and neurological complications.

"We are also encouraged by the improvements in C-reactive protein and 'good' cholesterol, which support the further evaluation of XOMA 052 in cardiovascular disease and other inflammatory indications," Xoma chairman and CEO Steven B Engle said in a statement.

The partners expect to begin clinical studies of Xoma 052 in cardiovascular disease in 2012.

Xoma and Servier announced their development and commercialisation deal for the drug in January. The agreement gives Servier worldwide rights to Xoma 052 for diabetes and cardiovascular disease indications and rights outside the US and Japan for other indications. Xoma has commercial rights and options in the US and Japan for multiple indications including Behcet's uveitis and other inflammatory and oncology indications.

Servier made an upfront payment of $35m under the deal, with the potential for another $470m in milestone payments and royalties. Servier will pay the first $50m and half of further development expenses for the Behcet's uveitis indication and will fund the cardiovascular disease and diabetes development programmes. Xoma is responsible for manufacturing throughout clinical development and launch and expects to be the long-term manufacturer of the product.

23rd March 2011

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