By Keith Darcé pv ["p. a_3"] = "Keith darcé"; Published March 16, 2011 at 10: 53 a.m., updated March 16, 2011 at 4: 02 pm
Amylin Pharmaceuticals and the Japanese partner, Takeda Pharmaceutical, voluntarily completed a phase 2 clinical trial of the enterprise of the San Diego experimental weight-loss therapy above water after a problem with one of the treatment of the ingredients, the drug makers said Wednesday.
The problem involved antibody activity that might have weight loss impact of metreleptin in two patients who took the drug in a previously completed clinical study, neutralized Amylin spokeswoman Anne Erickson said.
The present study combines metreleptin, a version of the human hormone leptin, and pramlintide, Symlin Amylin of diabetes drug, in a single obesity therapy
"We have taken this precaution so that we can thoroughly investigate this finding," said Dr. Orville Kolterman, Amylin, the chief medical officer of the suspension.
In a previous test of the combination of pramlintide-metreleptin participants lost an average of 25 pounds more than 24 weeks.
A partnership agreement November 2009 Amylin responsible for implementation of phase 2 trials of the experimental therapy. Takeda must inherit the work once the drug phase 3 trials. The Japanese company also has the rights for the commercialisation of treatment if it ever Food and Drug Administration approval receives.
Amylin paid a $ 75 million for the deal, which is also a second drug experimental obesity in phase 2 trials.
The setback announced that Wednesday was not that big of a blow to Amylin because Takeda is wearing most of the financial risk for bringing metreleptin pramlintide-to the market, said analyst Mark Schoenebaum, a biotechnology stock with ISI group in New York.
Amylin shares rose 5 cents to close at $ 11.08 Wednesday on the Nasdaq stock market.
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