DAC GLP-1 for Type II Diabetes

On April 12, 2004 ConjuChem Inc. announced interim Phase II results for DAC™: GLP-1. The company released results for patients who had received the first 28 days of therapy of the planned 3 month trial. Based on approximately 80 patients to date, ConjuChem reported a statistically significant reduction in Hgb A1C and glucose normalization or reduction in 80% of treated patients. A statistically significant reduction in body weight was also noted. The company reported no serious adverse events, no irritation at the injection site, no blood pressure changes and no antibody production. Transient nausea and vomiting was noted but the total numbers of patients experiencing these side effects was not reported.

GLP-1 is a naturally occurring 36 amino acid peptide delivered with ConjuChem’s drug affinity complex, DAC™. Essentially, DAC is a chemical ‘coupler’ that allows for GLP-1 to selectively bind with the body’s naturally occurring albumin. Albumin is a protein present in the blood stream that, when bound to GLP-1, will significantly increase its half-life. GLP-1 not bound to albumin has a half-life of minutes. There are several mechanisms of action hypothesized for GLP-1, such as the stimulation of insulin secretion, the delay of gastric emptying, the induction of Beta cell proliferation, the restoration of Beta cell sensitivity and the increase of peripheral sensitivity to insulin.

According to the National Center for Chronic Disease Prevention and Health Promotion, diabetes is becoming more prevalent in the United States. Diabetes surveillance indicates that between 1980 and 2002, the number of cases of diabetes more than doubled (from 5.8 million to 13.3 million). In 2002, 1.3 million adults between the ages of 18 and 79 years were newly diagnosed with diabetes. This represents an incidence of 7 new cases per 1000 population between the ages of 18 and 79 years of age.

Given the powerful epidemiologic trends currently being experienced in the United States concerning diabetes and risk factors leading to diabetes (obesity, diet, etc.), therapies that represent true innovation in the treatment of diabetes or the prevention of its complications have the potential to become High Impact Technologies. There are numerous companies looking at GLP-1 and similar peptides in the treatment of diabetes, perhaps most notably Amylin Corp. However to date, none have been approved for use in the United States. Given GLP-1’s early Phase II stage of development and the necessity for ongoing pivotal Phase III trials, no early assessment activities are required for DAC-GLP-1 at this time.

Technology Details
Target Disease / Indication: Type II Diabetes
Technology Classification: Drug
Body System: Endocrine System
Program Area: Medicine/Endocrinology
Regulatory Status: Phase II
BioHorizon Impact Score: 47/100 – Moderate