Amylin Pharmaceuticals Inc. announced Wednesday at the H&Qconference that it will start Phase II clinical trials on itsexperimental drug to treat type I diabetes, AC137, in February.
The San Diego company (NASDAQ:AMLN) also announced that ithas received a U.S. patent, No. 5,175,145, with broad coveragefor AC137 and related compounds, as well as a notice ofallowance for a second patent covering methods of treatingtype II diabetes.
"Although the Phase I studies were not designed to investigatetherapeutic efficacy, they did provide initial indications thatAC137 (or Normylin) can increase blood glucose," HowardGreen Jr., Amylin's chief executive officer, told the H&Qaudience. "The observation of these effects in humans is a keystep in further understanding the biologic and clinical impact ofthe amylin hormone."
The potential therapeutic is a modified form of the pancreatichormone amylin, which could play an important role inregulating carbohydrate and fat metabolism.
People with type I diabetes are deficient in both insulin andamylin. For them, Amylin is basing its therapeutic approach onreplacing amylin. For treating type II (adult) diabetes andobesity, the strategy is to block the excess amylin activity thatis thought to contribute to these metabolic disorders.
In the Phase II trials on Normylin, "... we hope to pioneer anentirely new therapeutic modality -- namely, a medicine aimedat reducing or preventing hypoglycemic episodes associatedwith insulin therapy," said Orville Kolterman, Amylin's medicaldirector.
Amylin's stock was up 38 cents a share on Wednesday, closingat $13.13.
-- Jennifer Van Brunt Senior Editor
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