Amylin Pharmaceuticals and partner Takeda Pharmaceutical have decided to shelve further development of the Phase II-stage obesity therapy candidate pramlintide/metreleptin. The combination treatment had been in development as a twice-daily injection.
The firms claim that the decision to discontinue the program is based on a commercial reassessment, which included the evaluation of a revised development plan. However, in March they suspended an ongoing Phase II trial evaluating pramlintide/metreleptin due to what was described as an antibody-related laboratory finding associated with metreleptin treatment in two patients who participated in a previously completed obesity clinical study.
“The interplay of hormonal signals such as amylin and leptin plays a crucial role in the regulation of body weight," comments Christian Weyer, M.D., svp of R&D at Amylin. “Advances in peptide engineering and delivery may help us leverage this biology to develop a therapy with less frequent dosing.”
Pramlintide is a synthetic analog of the human hormone amylin and constitutes the active ingredient in Amylin’s approved diabetes therapy Symlin®. Metreleptin is an analog of human leptin, also developed by Amylin. The pramlintide/metreleptin obesity program was the lead project in Amylin and Takeda’s worldwide collaboration focused on the development of treatments for obesity and related indications, which they signed back in 2009.
Having ditched the project, Amylin and Takeda say they will continue to evaluate other assets for the potential treatment of obesity as part of their ongoing collaboration. Further investigation of the metreleptin therapy-related antibody finding will also continue.
In May Amylin and the Juvenile Diabetes Research Foundation inked a research collaboration to fund a series of clinical studies evaluating the potential to co-formulate Symlin with insulin for the treatment of type 1 diabetes.