The Phase 2 clinical trial of BIOD-123 is a randomized, open label, parallel group study conducted at 33 investigative centers in
BIOD-123 is a proprietary formulation of injectable recombinant human insulin with EDTA, citrate and magnesium sulfate. It is designed to be more rapid-acting than mealtime insulin analogs currently used to treat patients with type 1 and type 2 diabetes. In earlier-stage clinical trials, BIOD-123 has been shown to be more rapidly absorbed following subcutaneous administration and have comparable injection site tolerability relative to the rapid-acting insulin analog marketed as Humalog®. Administered at the start of a meal, the time to peak insulin levels achieved by BIOD-123 more closely mimics the first-phase mealtime insulin release observed in healthy individuals. Since its inception in 2006,
Diabetes is a group of diseases characterized by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Humans need a minimum level of glucose in their blood at all times to function and stay alive. Insulin is a peptide hormone naturally secreted by the pancreas to regulate the body's management of glucose. When a healthy individual begins a meal, the pancreas' rapid release of insulin, known as first-phase insulin release, is critical to the body's overall control of glucose. Many patients with diabetes lack first-phase insulin release and must treat themselves with daily meal-time insulin injections to avoid the negative effects of hyperglycemia.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements about future activities related to the clinical development plans for the company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates. Forward-looking statements represent our management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may,"
"plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, the success of our product candidates, particularly our proprietary formulations of injectable insulin that are designed to be absorbed more rapidly than the "rapid-acting" mealtime insulin analogs presently used to treat patients with type 1 and type 2 diabetes and our glucagon presentation that is intended to treat patients experiencing severe hypoglycemia; our ability to
successfully complete a Phase 2 clinical trial of a proprietary insulin formulation in a timely manner, and the outcome of that trial; our ability to conduct pivotal clinical trials, other tests or analyses required by the
Seth D. Lewis, +1-646-378-2952
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