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Lilly Halts Development of BIL

The diabetes drug benefits prove inconclusive

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By: Kristin Brooks

Managing Editor, Contract Pharma

Eli Lilly and Co. has stopped development of its basal insulin peglispro (BIL), a potential treatment for type 1 and type 2 diabetes following conversations with regulatory authorities and other external experts, and not by any new safety signals, according to the company.

In February, Lilly delayed regulatory submission in order to assess 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. No drug-induced liver impairment or Hy’s Law cases were observed in more than 6,000 patients with type 1 and type 2 diabetes treated for up to 18 months (approximately 3,900 patients treated with BIL).

BIL, a hepato-preferential basal insulin, was being studied as a once-daily treatment for type 1 and type 2 diabetes. Its activity profile is derived from its reduced effect in peripheral tissue, making it more similar to endogenous insulin compared to other exogenous insulins with a conventional activity profile.

“While we are encouraged by the efficacy data we observed for BIL, we know that moving forward would have required a significant amount of time and investment with no assurance that we would find conclusive answers,” said Enrique Conterno, president, Lilly Diabetes. “We are disappointed in the outcome for BIL, but we have an unprecedented opportunity to build upon the industry’s broadest diabetes portfolio, which includes six new treatments approved since the middle of 2014. Lilly remains fully committed to innovative research in the diabetes space, including insulins.”

The decision is expected to result in a fourth-quarter charge R&D expense of an estimated $55 million.

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