Top-Line Data Expected in Third Quarter of 2013
DANBURY, CT, USA I July 11, 2013 I Biodel Inc. (BIOD) today announced that all scheduled follow-up visits have been completed for patients enrolled in the Phase 2 clinical trial of BIOD-123, an investigational ultra-rapid-acting injectable mealtime insulin therapy.
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: “Completing the BIOD-123 Phase 2 clinical trial is another significant milestone in the development of novel ultra-rapid-acting mealtime insulins to aid patients and healthcare professionals in the treatment of diabetes. We look forward to sharing the top-line results by the end of this quarter.”
Study Design
The Phase 2 clinical trial of BIOD-123 is a randomized, open label, parallel group study conducted at 33 investigative centers in the United States. In the trial, 132 patients with type 1 diabetes were randomized to receive either BIOD-123 or Humalog(R) to use as their mealtime insulin during an 18 week treatment period. Both arms of the study used insulin glargine, sold as Lantus(R), as the basal insulin. The clinical trial is designed to evaluate HbA1c control as the primary endpoint, and secondary endpoints include postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.
About BIOD-123
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(R). 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, Biodel‘s ultra-rapid-acting insulin program has involved 20 clinical studies and more than 1,000 patients with diabetes.
About Diabetes
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.
About Biodel
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. Biodel’s product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available at www.biodel.com.
SOURCE: Biodel
Post Views: 35
Top-Line Data Expected in Third Quarter of 2013
DANBURY, CT, USA I July 11, 2013 I Biodel Inc. (BIOD) today announced that all scheduled follow-up visits have been completed for patients enrolled in the Phase 2 clinical trial of BIOD-123, an investigational ultra-rapid-acting injectable mealtime insulin therapy.
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: “Completing the BIOD-123 Phase 2 clinical trial is another significant milestone in the development of novel ultra-rapid-acting mealtime insulins to aid patients and healthcare professionals in the treatment of diabetes. We look forward to sharing the top-line results by the end of this quarter.”
Study Design
The Phase 2 clinical trial of BIOD-123 is a randomized, open label, parallel group study conducted at 33 investigative centers in the United States. In the trial, 132 patients with type 1 diabetes were randomized to receive either BIOD-123 or Humalog(R) to use as their mealtime insulin during an 18 week treatment period. Both arms of the study used insulin glargine, sold as Lantus(R), as the basal insulin. The clinical trial is designed to evaluate HbA1c control as the primary endpoint, and secondary endpoints include postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.
About BIOD-123
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(R). 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, Biodel‘s ultra-rapid-acting insulin program has involved 20 clinical studies and more than 1,000 patients with diabetes.
About Diabetes
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.
About Biodel
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. Biodel’s product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available at www.biodel.com.
SOURCE: Biodel
Post Views: 35
