Boehringer Ingelheim and Eli Lilly have unveiled positive top-line late-stage data for empagliflozin just as the German group has decided to pull out of one of the projects covered by the firms' diabetes alliance.
First up, Lilly and BI announced results from four completed Phase III studies of empagliflozin. In all of them, the drug, a sodium glucose co-transporter-2 (SGLT2) inhibitor, met its primary endpoint of reducing blood glucose levels compared to placebo.
Incidence of adverse events was similar for placebo, empagliflozin 10mg and 25mg, but genital infections occurred more often with both dosages of the BI/Lilly drug. The aforementioned infections are linked to SGLT2 inhibitors as this class of drugs, which works independently of insulin, causes a substantial increase in the amount of glucose that flows out in the urine.
Klaus Dugi, head of medicine at BI, said many patients with type 2 Diabetes are not meeting their blood sugar level goals, and alternative treatment options are needed. He added that "we believe we are now one step closer to bringing a relevant treatment option in a new drug class to these patients".
BI and Lilly expect to file empagliflozin for regulatory approval this year in the USA, Europe and Japan. If given the green light, it will compete in Europe with AstraZeneca/Bristol-Myers Squibb's Forxiga (dapagliflozin), which was turned down by the US Food and Drug Administration a year ago; an FDA advisory committee will meet this week to review Johnson & Johnson's SGLT2 inhibitor canagliflozin.
Lilly and BI formed their diabetes alliance in January 2011 but the partnership has taken a bit of a knock with the news that the latter has terminated its participation in the development of LY2605541, an experimental basal insulin analogue.
BI says the decision is the result of "independent strategic portfolio considerations". However, Ulrich Drees, head of international project management, insisted that "there is an excellent spirit of collaboration in our alliance with Lilly", and they will continue to develop Trajenta (linagliptin), empagliflozin and LY2963016, a new insulin glargine product.
Gwen Krivi, head of product development at Lilly Diabetes, said that "we're encouraged by the pre-clinical, Phase I and II data we’ve seen" and "we look forward to sharing the Phase III data results…as early as 2014". Lilly hopes LY2605541 will compete with Sanofi's blockbuster Lantus (insulin glargine).