Positive interim data from XBiotech monoclonal antibody Phase II study for type 2 diabetes

Published on October 29, 2012 at 12:51 PM · No Comments

 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 improve control of blood sugar levels by blocking inflammation in the pancreas. 

Interim results from the Phase II MABp1 trial demonstrate patients entering the study with average HbA1c levels of 7.4% achieved a 0.2% decrease in HbA1c level by week 8, a significantly more rapid response than the most recent FDA approved treatment for type 2 diabetes, linagliptin (Tradjenta®).   When used as a monotherapy in patients with entry HbA1c levels of ≤ 7.5%, linagliptin did not demonstrate the same 0.2% decrease in HbA1c until week 24.

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