XBiotech Reports Positive Phase II Interim Analysis Results From Type 2 Diabetes Study
AUSTIN, Texas, Oct. 29, 2012 /PRNewswire/ -- XBiotech, a privately held biotechnology company, announced positive interim analysis results today from a Phase II study using a True Human monoclonal antibody (MABp1) in patients with type 2 diabetes. Results from this study continue to reinforce the role of IL-1α as a master regulator of chronic inflammation in multiple disease states, and the therapeutic benefits of neutralizing antibodies produced from the XBiotech platform. The Company recently announced FDA Fast Track Designation for development of cancer associated cachexia therapy, as well as positive results from a Phase II study in psoriasis, using MABp1.
According to the Centers for Disease Control (CDC), 18.8 million people have been diagnosed with diabetes. Type 2 diabetes accounts for about 95 percent of diagnosed diabetes patients. Per the CDC, up to 74 percent of those with Type 2 diabetes are pre-insulin dependent. These patients still have a functioning pancreas and are among the approximately 13 million patients who could potentially benefit from treatment with MABp1.
The Phase II clinical study is designed to assess safety and pharmacokinetics of MABp1 in the diabetic patient population. Patients enrolled in the study met the American Diabetes Association (ADA) diagnostic criteria for type 2 diabetes, and were diagnosed >3 months prior to screening. The primary efficacy endpoint of glycemic control, as measured by glycated hemoglobin (HbA1c) levels, evaluates the ability of MABp1 to impro