Eli Lilly said today it would halt development of basal insulin peglispro (BIL), nearly a year after the company said it would delay its regulatory submission for the once-daily type 1 and type 2 diabetes treatment.
The delay followed changes in liver fat observed with BIL treatment compared with insulin glargine treatment in the Phase 3 IMAGINE trials. More than 6,000 patients with type 1 and type 2 diabetes were treated for up to 18 months in the trials, with about 3,900 patients treated with BIL. No drug-induced liver impairment or Hy's Law cases were observed, according to the company.
In the months since, Lilly said, it engaged with regulators and other external experts, seeking additional clarity on the liver fat data in order to assess potential development plans for BIL that could provide.
Lilly insisted that the decision to stop BIL development resulted from those talks, and not from any new safety signals. The pharma giants said it will now focus R&D efforts on other potential treatments.
BIL is a hepato-preferential basal insulin with an activity profile derived from its reduced effect in peripheral tissue. That made BIL more similar to endogenous insulin compared to other exogenous insulins with a conventional activity profile, according to Lilly.
“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,” Lilly Diabetes president Enrique Conterno said in a statement. “We are disappointed in the outcome for BIL, but we have an unprecedented opportunity to build upon the industry's broadest diabetes portfolio.”
That portfolio includes six new treatments approved since the middle of 2014: “Lilly remains fully committed to innovative research in the diabetes space, including insulins,” Conterno added.
The company said its decision is expected to result in a fourth-quarter charge to Lilly's GAAP and non-GAAP R&D expense of an estimated $55 million pre-tax, or approximately 3 cents per share after-tax.
Lilly said its previously issued GAAP EPS guidance of $2.40-$2.45 and non-GAAP EPS guidance of $3.40-$3.45 will remain unchanged. Lilly plans to report its 2015 results on January 28, 2016.