Amylin Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited
today announced that they have suspended clinical activities in an ongoing
Phase 2 study examining the safety and effectiveness of the investigational
combination therapy pramlintide/metreleptin for the treatment of obesity. The
clinical study was voluntarily halted to investigate a new antibody-related laboratory
finding with metreleptin treatment in two patients who participated in a
previously completed clinical study of obesity.
"The safety of patients in our clinical programs is of
paramount concern to the companies. We have taken this precaution so that we
can thoroughly investigate this finding," said Orville Kolterman, M.D., senior
vice president and chief medical officer of Amylin Pharmaceuticals.
"Together with our partner, Takeda, we are committed to working closely
with clinical investigators, regulators and outside experts to determine the
best path forward." Independent of the partnership agreement with Takeda, Amylin
confirmed that today's announcement does not affect Amylin's lipodystrophy development
program investigating the use of metreleptin to treat diabetes and/or
hypertriglyceridemia (high levels of triglycerides in the bloodstream) in
patients with rare forms of lipodystrophy.
About Pramlintide/Metreleptin Combination Treatment Pramlintide
acetate is a synthetic analog of the natural hormone amylin, a neurohormone
secreted by the pancreas that is known to play a role in the regulation of
appetite, food intake and postprandial glucose concentrations. To date,
approximately 8,000 individuals have received pramlintide in clinical trials,
including more than 950 in obesity studies. Metreleptin (methionyl recombinant
leptin; r-metHuLeptin) is an analog of human leptin, a neurohormone secreted by
fat cells that plays a fundamental role in the regulation of energy metabolism
and body weight. To date, more than 1,200 overweight or obese individuals have
received metreleptin in clinical trials, several of which were 16 weeks or
longer in duration.