Lilly's Diabetes Drugs Meet Endpoints In Phase III Studies
Zacks Investment Research | Jun 25, 2018 11:09PM ET
Eli Lilly and Company (NYSE:LLY) along with Boehringer Ingelheim announced positive top-line data from two clinical studies – EASE 2 and EASE 3 – from the phase III EASE program evaluating SGLT2 inhibitor, Jardiance (empagliflozin), in type I diabetes.
Data showed that Jardiance in addition to insulin therapy met the primary endpoint of reduction of A1C, average blood sugar level, from baseline after 26 weeks of treatment. Detailed results will be presented at the European Association for the Study of Diabetes Annual Meeting in October.
The studies evaluated three doses of Jardiance – 2.5mg, 10mg and 25mg – in adult patients. Type I diabetes is a chronic disease that impacts the production of insulin in body, which controls blood sugar level. The disease affects approximately 1.3 million adults in the United States among whom more than two-thirds cannot meet target blood sugar levels, requiring life-long daily insulin administration.
Jardiance is approved for treating type II diabetes. A potential approval in type I diabetes will boost the prospects of the drug.
Year to date, shares of Lilly have risen 1.6% against the industry ’s decline of 4.8%.
In a separate press release, Lilly announced data from phase III VIVID study evaluating Humulin R U-500 delivered through Insulet Corporation’s (NASDAQ:PODD) investigational insulin pump Omnipod U-500 compared to multiple daily injections (“MDI”). The study evaluated Humulin R U-500, a highly concentrated insulin formulation, in insulin-resistant type II diabetes patients and who require daily doses of more than 200 units of insulin.
Data showed that the drug administered through the investigational pump reduced A1C levels by 1.27% from baseline after 26-weeks compared to 0.85% for MDI administration. Moreover, administration through the pump also lowered total daily insulin dose by 0.47 units/kg compared to MDI.
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