By Brady Huggett
Amylin Pharmaceuticals Inc. presented positive results from the most recent Phase II study of its diabetes product, AC2993 (synthetic exendin-4), at the American Diabetes Association¿s 61st annual meeting, held in Philadelphia.
Amylin, of San Diego, gave results showing all three dosing regimens resulted in statistically significant reductions in glycated hemoglobin (HbA1c) and fructosamine, relative to placebo. The 28-day, triple-blind, placebo-controlled study involved 109 patients with Type II diabetes who were inadequately controlled with sulfonylureas and/or metformin. Study assessments included changes from baseline in HbA1c, serum fructosamine and body weight.
AC2993 treatment led to statistically significant reductions in mean HbA1c compared to placebo. Reductions in HbA1c of greater than or equal to 0.5 percent were achieved by 90 percent of AC2993 subjects compared to 33 percent of placebo subjects. The change in body weight between AC2993 and placebo-treated subjects did not achieve statistical significance. The most common adverse event reported was mild-to-moderate nausea.
The company said the data support the progression of AC2993 into Phase III development. Its stock (NASDAQ:AMLN) fell $1.24 Monday, or nearly 9 percent, to close at $12.88.
In other news from the ADA meeting:
¿ Alkermes Inc., of Cambridge, Mass., said results were presented from a Phase I trial of its inhaled insulin, based on its AIR pulmonary drug delivery system. The poster presentation demonstrated that its insulin formulation showed a rapid onset of therapeutic action, dose-dependent glucose lowering ability and competitive biopotency. The formulations were developed in collaboration with Eli Lilly and Co., of Indianapolis.
¿ Aradigm Corp., of Hayward, Calif., and Novo Nordisk A/S, of Bagsvaerd, Denmark, reported data on a study in smokers and nonsmokers using the AERx insulin Diabetes Management System, finding the insulin delivery route to be safe and effective. The study found the absorption of insulin to be enhanced in smokers, compared to non-smokers, and that both groups tolerated pulmonary insulin equally well. The study showed the variability of insulin absorption was very low in individual smokers and similar to the nonsmoking group. No safety issues or major adverse events were reported.
¿ Emisphere Technologies Inc., of Tarrytown, N.Y., published an abstract, ¿New Formulation of Human Insulin.¿ The study examined insulin absorption and hypoglycemic response of human insulin formulated with several oral delivery agents in nondiabetic large animals. The insulin and delivery-agent combinations resulted in reduction in blood glucose levels. The company also said it initiated the dosing phase of two studies ¿ being conducted in the Netherlands and Israel ¿ evaluating its proprietary oral delivery technology with insulin.
¿ Inhale Therapeutic Systems Inc., of San Carlos, Calif., released data from Phase III studies being conducted by Pfizer Inc. and Aventis Pharma with inhaled insulin (Exubera) using Inhale¿s advanced inhaleable technologies. More patients with Type II diabetes who were treated with inhaled insulin achieved the recommended blood glucose levels than patients who received only insulin injections, according to the company. Exubera is being developed for patients with Type I and Type II diabetes through a collaboration between New York-based Pfizer and Frankfurt, Germany-based Aventis Pharma. The six-month study involved 299 patients divided into two groups: one group received inhaled insulin (Exubera) before meals plus a single bedtime dose of Ultralente (long-acting insulin); the other received the conventional regimen of insulin injections. The data showed that HbA1c levels decreased similarly in both groups and that inhaled insulin provided comparable glycemic control to that in the conventional subcutaneous insulin regimen. Also, inhaled insulin achieved target HbA1c levels of less than 7 percent in a greater proportion of patients compared to injected insulin (46.9 percent of patients receiving inhaled insulin over 31.7 percent of patients receiving subcutaneous injections).
¿ Insmed Inc., of Richmond, Va., presented results of Phase II trials of patients with Type II diabetes being treated with its two lead compounds, INS-1 and SomatoKine, detailing the safety and efficacy of the products. INS-1 is a naturally occurring small molecule that acts as an orally active insulin sensitizer to restore the body¿s sensitivity to insulin. SomatoKine is a recombinant protein being developed as an injectable insulin sensitizer targeted toward the management of patients with advanced Type I or Type II diabetes who are not adequately managed by insulin therapy.