Lilly dumps basal insulin peglispro development program

In what is seen as a major blow to Eli Lilly’s (NYSE: LLY) diabetes program, the company said on Friday that it will cease development of basal insulin peglispro (BIL), a potential treatment for type 1 and type 2 diabetes, in order to focus R&D efforts on other assets in its portfolio and pipeline. However, rather surprisingly, Lilly’s shares closed the day up 4.26% at $86.61.

In February, Lilly announced it was delaying regulatory submission in order to better understand and characterize the potential effects, if any, of changes in liver fat observed with BIL treatment compared with insulin glargine treatment in the Phase III IMAGINE trials (The Pharma Letter February 23). No drug-induced liver impairment or Hy's Law cases were observed in the IMAGINE clinical development program of more than 6,000 patients with type 1 and type 2 diabetes treated for up to 18 months (around 3,900 patients treated with BIL).

Over the past several months, Lilly engaged with regulatory authorities and other external experts to assess potential development plans for BIL that could provide additional clarity on the liver fat data observed in the IMAGINE trials. The decision to stop the program was informed by these conversations - and not by any new safety signals – and was ultimately driven by the decision to focus R&D efforts on other potential treatments.