SAN FRANCISCO_ Amylin Pharmaceuticals Inc., which alreadyhas shown that its drug AC137 reduced post-meal glucose levels inType I diabetics, said Tuesday that the amylin analog also had thateffect in late-stage Type II diabetics using insulin.
The San Diego company presented that data at the Hambrecht &Quist Inc. 13th Annual Life Sciences Conference here. Thesignificance to Amylin is the increased market potential, adding 5million insulin-using Type II diabetics to the 2 million Type Idiabetics who could benefit from the drug.
"We're seeing results that are virtually identical in terms ofsmoothing in Type II diabetes," Ted Greene Jr., Amylin's chairmanand CEO, told BioWorld. The next step, he said, is to study whetherthe same results can be seen with subcutaneous delivery.
"The odds are very good of that," he said, since the results mirrorthose seen in Type I diabetics. "This fits with the finding that amylinand insulin are co-secreted from pancreatic beta cells. We believethat restoring missing or deficient amylin with AC137 atphysiological levels is a rational therapeutic approach to achieve . . .improved glucose control in those diabetic patients who now useinsulin because their pancreatic beta cells have been destroyed inType I diabetes, or are failing in late-state Type II diabetes."
Greene said an 11-patient clinical pharmacology study of late-stage,insulin-using diabetics showed a 27 percent reduction in post-mealglucose levels, four hours after meals. The study was controlled anddouble-blinded with each patient serving as his or her own control.
Those results were similar to data the company released in June,which showed AC137, or tripo-amylin, improved post-meal glucosecontrol in Type I diabetes. But that study also showed that the drugdid not measurably alter the hypoglycemia (dangerously low bloodglucose levels) induced by experimental insulin overdose.
The mixed message, combined with a volatile market, resulted in thecompany's stock (NASDAQ:AMLN) falling 33 percent to close at$7.50 per share. Amylin's stock was up 50 cents to $6.25 onTuesday's news.
Marjorie Sennett, Amylin's vice president and chief financial officer,told BioWorld that investors now better understand the company'sstory. "Hypoglycemia is something that we will measure as asecondary endpoint in Phase III trials," she said. "It would be icingon the cake."
AC137, a human amylin analog, is being studied in more than 300patients in a Phase IIb dose-ranging trial. Greene said the "critical-path studies should be wrapped up by mid-year," and that Phase IIIstudies in Type I diabetes should begin in the second half of 1995.
Phase II studies showed that AC137 produced peak blood levels oftripo-amylin in diabetic patients that were consistent with the rangeof amylin found in non-diabetics.
Separately, the company is developing amylin-blockade peptides fortreatment of metabolic disorders in which excess amylin is believedto contribute, such as insulin resistance syndrome, with its associatedhypertension, obesity and hyperinsulinemia. The company, alongwith London-based Glaxo plc, has two injectible amylin receptorantagonists in Phase I studies. The companies are researching orallyavailable amylin blockers. n
-- Jim Shrine
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