Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) announced today that the companies have selected the combination treatment of pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, for advancement toward Phase 3 development. The decision to advance the program followed encouraging results from a 52-week blinded, placebo-controlled Phase 2 extension study. The pramlintide/metreleptin combination met the key target criteria of sustained and robust weight loss.

"There is an enormous unmet need to help reduce the individual and economic burden of obesity," said Christian Weyer, M.D., vice president, medical development at Amylin Pharmaceuticals. "Through our global co-development and commercialization agreement with Takeda, we are committed to developing innovative therapies to help the millions of people who need better solutions to manage obesity. Today's announcement is an important step forward in helping us make good on that commitment."

"We are pleased with the results of the Phase 2 extension study for the pramlintide/metreleptin combination therapy," said Nancy Joseph-Ridge, M.D., general manager of Takeda's Pharmaceutical Development Division. "This potential new therapy continues to build on our commitment to the management of obesity."

In this extension of a 28-week Phase 2 dose-ranging study, patients who continued treatment with pramlintide/metreleptin for a total of 52 weeks demonstrated sustained weight loss, whereas those continuing on placebo regained almost all of their weight. Consistent with results at 28 weeks, the most robust efficacy was seen in patients with a body mass index (BMI) less than 35 kg/m2.

The combination therapy appeared to be generally well tolerated through 52 weeks, with nausea and injection site adverse events observed as the most common side effects on initiation of pramlintide or metreleptin in combination treatment. Following initiation of therapy, these adverse events occurred at a reduced rate over time in patients continuing combination therapy.

Results from the 28-week portion of this Phase 2 study have been previously reported. Patients who completed the 28-week study had the option to enroll in an extension protocol that assessed longer-term safety and efficacy of various dose combinations of pramlintide and metreleptin to a total of 52 weeks. Approximately 275 patients (75% of those eligible) chose to continue in the extension.

Data from this study may be presented in a future medical forum.

Davalintide Status Update

Amylin has also completed a Phase 2 study of davalintide, a second-generation analog of amylin, for the treatment of obesity. In this study, the weight loss efficacy and tolerability profile of davalintide was not improved over pramlintide, and was inferior to that of the pramlintide/metreleptin combination. Based on this information, Amylin and Takeda, as part of their co-development and commercialization agreement, have decided to halt further development of davalintide at this time.

SOURCE Amylin Pharmaceuticals, Inc.