By Kim Coghill
Amylin Pharmaceuticals Inc.¿s second diabetes product entered Phase III trials just two months after the FDA sent the company an ¿approvable¿ letter for its lead compound targeting Type I and Type II insulin-dependent diabetics.
The San Diego-based company Monday said it has started the first of three Phase III pivotal trials of AC2993 (synthetic exendin-4) for Type II diabetes. The 400-patient study will look at AC2993¿s ability to improve glucose control in Type II diabetics who are not achieving desired blood glucose levels with metformin alone.
This positive news follows Amylin¿s announcement in mid-October that the FDA issued an approvable letter for Symlin (pramlintide), despite a negative vote by the FDA¿s Endocrinologic and Metabolic Drugs Advisory Committee. (See BioWorld Today, Oct. 15, 2001, and July 27, 2001.)
¿Next year is looking to be an exciting year,¿ Daniel Bradbury, executive vice president for Amylin, told BioWorld Today. ¿I think one of the exciting things about Amylin Pharmaceuticals is we have sole rights to two late-stage diabetes programs and that is very unusual for a biotechnology company.¿
AC2993, a 39-amino acid peptide, will be the subject of two other Phase III trials in a program known as ¿AC2993: Diabetes Management for Improving Glucose Outcomes¿ (AMIGO). The first study is expected to be completed late next year while the second and third studies will commence in the first quarter of 2002. All the studies are expected to be completed by the end of 2003.
The second study, a 400-patient trial, will evaluate AC2993 when added to sulfonylureas. The third study, of 800 patients, will look at the effects of AC2993 when added to the combination of metformin and sulfonylureas.
In Phase II studies, AC2993 treatment led to statistically significant reductions in mean glycated hemoglobin (HbA1c) and fructosamine, compared to placebo.
Bradbury said AC2993 targets patients with Type II diabetes who are in an earlier stage of their disease, while Symlin is for insulin users who are at a later stage of Type II diabetes or who have Type I diabetes.
The FDA is requiring Amylin to conduct additional tests before it clears Symlin for marketing. Bradbury wouldn¿t say when the company believes Symlin will be for sale, but he did say analysts are projecting a launch date in 2003 with peak sales of $260 million worldwide.
Symlin is an analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas. Amylin proposes injecting diabetes patients with Symlin three times a day in conjunction with insulin. The product controls blood sugar and helps reduce weight gain.
The company also is testing a long-acting-release formulation of AC2993, or AC2993 LAR, as a once-a-month injectable product for Type II diabetes. That product is in Phase I development, as is AC3056 for potential treatment for metabolic disorders relating to cardiovascular disease.
Amylin¿s stock (NASDAQ:AMLN) closed Monday at $8.726, down 39 cents.