Amylin and Takeda said that 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.
In the 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 35kg/m2.
The study results suggested that 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.
The 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.
Christian Weyer, vice president of medical development at Amylin, said: “There is an enormous unmet need to help reduce the individual and economic burden of obesity. Through our global co-development and commercialisation 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.”
Nancy Joseph-Ridge, general manager of pharmaceutical development division at Takeda, said: “We are pleased with the results of the Phase 2 extension study for the pramlintide/metreleptin combination therapy. This potential new therapy continues to build on our commitment to the management of obesity.”