XOMA 052, an once-a-month injection to treat diabetes, is undergoing Phase 2b dose-ranging clinical trial.
Enrollment has started in a 325-patient Phase 2b dose-ranging clinical trial of its antibody candidate, XOMA 052, in type 2 diabetes patients, Xoma announced.
The randomized, placebo-controlled trial will be conducted at up to 70 U.S. sites, will evaluate multiple dose levels of XOMA 052 over six months and is intended to guide Phase 3 development.
Xoma estimates that top-line results from XOMA 052 study will be available in the first quarter of 2011.
Type 2 diabetes patients enrolled in the trial will be on stable metformin therapy and will receive monthly treatment for six months with one of four doses of XOMA 052 or placebo administered by subcutaneous injection.
The primary outcome measure is mean change in glycated hemoglobin, HbA1c, from baseline. Secondary endpoints include additional diabetic parameters as well as inflammatory and cardiovascular disease markers.
“XOMA 052, an antibody to interleukin-1 beta, is a potential paradigm-shifting treatment for Type 2 diabetes and cardiovascular disease and other inflammatory diseases,” stated Steven B. Engle, Xoma chairman and chief executive officer.
Previously, Xoma announced that the XOMA 052 Phase 2 program would include a Phase 2a extended safety trial in Type 2 diabetes patients for which interim results are expected in the fourth quarter of this year, a cardio-metabolic trial in Type 2 diabetes patients and a trial in patients with Type 1 diabetes funded by the Juvenile Diabetes Research Foundation.
In 2009, XOMA announced results from successful Phase 1 trials of XOMA 052 in 98 Type 2 diabetes patients, demonstrating that XOMA 052 was well tolerated, could be given on a monthly or less frequent schedule and showed positive biologic activity in diabetic parameters such as HbA1c and reduction in biomarkers associated with cardiovascular risk such as C reactive protein.
XOMA 052 has the potential to improve the treatment of patients with a wide variety of inflammatory diseases. XOMA 052 binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine involved in the development of Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and other diseases.
By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation.
XOMA 052 has a half-life, binding properties and specificity for IL-1 beta that may provide for convenient dosing of once per month or less frequently.
Xoma developed XOMA 052 using the company’s proprietary antibody technologies, and the company owns worldwide rights to the antibody and related intellectual property.
Xoma is actively pursuing a partnership for the development and commercialization of XOMA 052.
Xoma discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government.
Besides Xoma 052, the company’s proprietary product pipeline includes XOMA 3AB, an antibody candidate in pre-IND studies to neutralize the botulinum toxin, among the most deadly potential bioterror threats, under development through funding provided by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health
Xoma develops products with pharmaceutical companies including Novartis AG, Merck & Co., Inc. and Takeda Pharmaceutical Company Limited.
Xoma has marketed antibody products, including Lucentis (ranibizumab injection) for wet age-related macular degeneration and Cimzia (certolizumab pegol) for rheumatoid arthritis and Crohn’s disease.
The company has an antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering, affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies.
BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins.