Takeda obesity drug falters at phase II
pharmafile | March 18, 2011 | News story | Research and Development | Alli, Amylin, Contrave, Meridia, Qnexa, Takeda, Xenical, lorcaserin, metreleptin, obesity, pramlintide
Yet another investigational drug appears to have faltered on the rocky path to develop anti-obesity treatments.
Takeda Pharmaceutical Company and Amylin Pharmaceuticals have suspended clinical activities in their phase II trial of combination therapy pramlintide/metreleptin after safety issues emerged.
San Diego-based Amylin and Takeda, whose HQ is in Tokyo, said they were “voluntarily halted to investigate a new antibody-related laboratory finding with metreleptin treatment in two patients”.
The patients at risk in the Amylin/Takeda trial have already participated in a completed clinical study of obesity, the firms said in their statement.
“The safety of patients in our clinical programmes is of paramount concern to the companies,” said Orville Kolterman, Amylin’s chief medical officer. “We have taken this precaution so that we can thoroughly investigate this finding.”
Pramlintide acetate is a synthetic analogue of amylin, a neurohormone secreted by the pancreas that plays a role in the regulation of appetite, food intake and postprandial glucose concentrations.
Metreleptin is an analogue of human leptin, a neurohormone that comes from fat cells and is key in the regulation of energy metabolism and body weight.
Both have been used in trials before. Amylin insists that the halting of this trial will not effect another of its programmes investigating metreleptin in the treatment of diabetes and hypertriglyceridemia in patients with rare forms of lipodystrophy.
The development continues a poor run for investigational compounds in this therapy area in recent years, following the FDA’s rejection of Orexigen’s Contrave, Arena Pharmaceuticals’ lorcaserin and Vivus’ Qnexa.
And if the development of such drugs has had a chequered history, even those which have actually made it to market have not stayed the course in recent years.
Last November Abbott pulled its own anti-obesity drug Meridia in the US after trials showed it increased the risk of stroke and heart attack in patients with heart disease.
Meanwhile Sanofi-Aventis’ Acomplia was withdrawn in Europe in 2008 and never even made it on to the US market after FDA concerns over psychiatric side effects.
This leaves Roche’s Xenical, plus its OTC version – marketed as Alli by GlaxoSmithKline, as the only contenders in a market worth more than $1 billion.
Adam Hill
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