Amylin Pharmaceuticals said its tripro-amylin compound, AC137,showed statistical significance in reducing average 24-hour plasmaglucose levels in Phase IIB studies for treatment of Type I diabetes.
The trials are part of an ongoing series of clinical studies of AC137,which is an analog of the hormone amylin. Patients with diabeteshave deficiencies in both insulin and amylin causing dangerous shiftsin blood glucose levels.
AC137 is being tested for use in conjunction with insulin to betterstabilize glucose levels for patients with Type I (juvenile-onset) andType II diabetes.
Marjorie Sennett, vice president and chief financial officer for SanDiego-based Amylin Pharmaceuticals, said the company expects tobegin Phase III studies in the second half of 1995 for Type I diabetes.
The Phase IIB data reported Monday involved trials at 14 medicalcenters and 159 patients with Type I diabetes. In addition to insulin,participants self-injected either a placebo or AC137 in one of threedoses (10, 30 and 100 micrograms) twice a day for 14 days.
After the two-week treatments, glucose levels were measured for 24hours. The group that received a 30-microgram dose of AC137experienced "a 35 milligrams per deciliter average lowering frompretreatment plasma glucose averages."
Sennett said those findings were the first showing that AC137significantly reduced average 24-hour glucose levels, one of threeendpoints. The trials also confirmed prior studies involving the othertwo objectives: that the drug is well tolerated and that it achievesstatistical significance in reducing post-meal plasma glucose levels.
In addition, the Phase IIB studies determined the target dose rangefor the Phase III trials. The safety analysis showed no serious adverseevents at any of the three dosages. In assessing post-meal glucoselevels, patients who received both 30 and 100 microgramsexperienced a significant reduction. And for the endpoint involvingaverage 24-hour glucose levels, participants taking 100 microgramsshowed a reduction, but the data did not achieve statisticalsignificance. Those receiving 10 micrograms experienced no changein either post-meal or average 24-hour glucose levels.
Sennett said another ongoing Phase IIB trial involves a 28-day dosefrequency analysis.
Amylin Pharmaceuticals (NASDAQ:AMLN) closed Monday at $6,unchanged. n
-- Charles Craig
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