XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced that the US Patent and Trademark Office has issued two new patents that significantly expand the company's intellectual property portfolio relating to its anti-inflammatory antibody, XOMA 052, that targets interleukin-1 beta (IL-1 beta). One of the patents covers methods of treating Type 2 diabetes with high affinity antibodies and antibody fragments that bind to IL-1 beta, including XOMA 052. The high affinity antibodies, such as XOMA 052, offer potential advantages in Type 2 diabetes because they may provide greater potency, less frequent dosing, reduced dose levels, and manufacturing efficiencies.

Additional claims in this patent relate to methods of reducing or preventing complications or conditions associated with Type 2 diabetes including retinopathy, renal failure, wound healing and cardiovascular disease, with these high affinity IL-1 beta antibodies. The patent also includes claims that relate to methods of treatment of Type 2 diabetes with high affinity IL-1 beta antibodies in conjunction with additional agents.

A second patent covers methods of treating IL-1 related inflammatory diseases, including rheumatoid arthritis and osteoarthritis, with XOMA 052 and other antibodies and antibody fragments with similar binding properties for human interleukin-1 beta (IL-1 beta).

The patents expire in 2027 (US 7,695,718) and 2026 (US 7,695,717), respectively. With these patents, the intellectual property portfolio for XOMA 052 includes four issued patents in the US and one granted patent in Europe. Additional applications are pending in the US and other countries.

"It is remarkable that targeting one component of the IL-1 pathway, as we have with our high affinity IL-1 beta antibody XOMA 052, may address a broad range of diseases that have inflammation as a common disease cause," said Steven B. Engle, XOMA's chairman and chief executive officer. "The issuance of these patents highlights XOMA's innovative research with IL-1 beta antibodies and in particular our pioneering role in applying IL-1 beta targeting to the treatment of Type 2 diabetes."

The concept of targeting the IL-1 pathway in some inflammatory diseases has been clinically validated by three FDA-approved therapies, one for rheumatoid arthritis, and two for cryopyrin-associated periodic syndromes (CAPS). These and other IL-1 targeting products are currently in clinical development to address significant unmet medical needs including the treatment of Type 1 diabetes, Type 2 diabetes, cardiovascular disease, rheumatoid arthritis and gout.

XOMA is conducting two Phase 2 clinical trials of XOMA 052 in patients with Type 2 diabetes and a Phase 2 trial in Type 1 diabetes. The Phase 2 trials follow a successful 98 patient Phase 1 program in Type 2 diabetes patients in which XOMA 052 was shown to be well-tolerated, demonstrated evidence of biological activity in diabetes measures and cardiovascular biomarkers, and had a half-life that may provide convenient dosing of once per month or less frequently.