Pramlintide/metreleptin: Phase II halted

Amylin and partner Takeda suspended a double-blind, placebo-controlled, U.S. Phase II trial of pramlintide/metreleptin to treat obesity after 2 patients in a previously completed study developed "antibody-related" responses to metreleptin. According to Amylin, a potential "neutralizing activity" to metreleptin and leptin may have occurred. About 60 patients have been enrolled in the trial to date. The 2 patients were enrolled in a Phase II trial in which Amylin previously reported that pramlintide/metreleptin was well tolerated with no cardiovascular or psychiatric safety signals, but missed the primary endpoint of significantly reducing percent body weight from baseline to week 28 vs. placebo (see BioCentury, July 13, 2009).

Amylin said activities to support a Phase III trial of the combination therapy, including co-formulation and manufacturing scale-up, are continuing. Takeda is responsible for development of pramlintide/metreleptin after Phase II testing under a 2009 deal to co-develop and commercialize therapeutics for obesity and related conditions (see BioCentury, Nov. 9, 2009). Amylin said it is too early to comment on the timing of the trial. ...