Amylin Pharmaceuticals Inc. on Monday said that asecond Phase II clinical trial produced more evidence thatpramlintide, an analog of the hormone amylin, waseffective in lowering blood glucose concentrations inpatients with Type I or juvenile onset diabetes.
The study, which involved 184 patients in a 28-day,double-blind Phase II study, replicated an earlier 14-daystudy which showed pramlintide effective in loweringpost-meal and average 24-hour blood glucoseconcentrations in patients with Type I diabetes.
Pramlintide is an analog to the human hormone amylinwhich together with insulin controls blood glucose levels.
Amylin, located in San Diego, is collaborating withLifeScan Inc. a subsidiary of Johnson & Johnson, of NewBrunswick, N.J.
The findings clear the way for launch of a one-year, PhaseIII clinical trial of pramlintide in 400 Type I diabetespatients. The company already is testing pramlintide in aclinical trial involving patients with Type II maturityonset diabetes who inject insulin.
"The news from the Phase II study is one moreconfirmation that pramlintide is clinically meaningful andstatistically significant in lowering blood sugar," saidBrandon Fradd, an analyst at Montgomery Securities Inc.of San Francisco.
Fradd expects that pramlintide will have littlecompetition if it is approved by the FDA. Pramlintidewould be marketed to the 2 million Type I juvenilediabetes patients and the 1 million to 2 million Type IIdiabetes patients who use insulin, said Marjorie Sennett,Amylin's vice president and chief financial officer.
Pramlintide's marketing advantage would come from itsability to lower increases in blood glucose, not as areplacement to insulin, Sennett told BioWorld Today."The advantages of lowering blood glucose, which weredocumented in the National Institutes of Health-sponsored Diabetes Control and Complication Trial,significantly reduced the onset of long-termcomplications such as blindness, kidney failure and nervedamage."
Pramlintide created a few side effects among patients inthe Phase II trial including gastrointestinal symptoms insome patients that subsided after one week of treatment,said Sennett.
Amylin said results from the recently announced Phase IIIclinical trial in Type I diabetics, and the one startedearlier this year to test the drug's effectiveness in Type IIdiabetics who use insulin, will form the basis for its newdrug application.
Amylin's stock (NASDAQ:AMLN) closed down 19 centsMonday to $8 per share. n
-- Michele L. Robinson Washington Editor
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