Lilly’s Diabetes Drugs Meet Endpoints in Phase III Studies

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Eli Lilly and Company 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 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.

Zacks Rank & Stock to Consider

Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A couple of better-ranked stocks from the same space are Aeglea BioTherapeutics, Inc. AGLE and ANI Pharmaceuticals, Inc. ANIP. Both the stocks carry a Zacks Rank #2 (Buy).

Aeglea’s loss per share estimates narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 101.3% so far this year.

ANI Pharmaceuticals’ earnings per share estimates moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 3.9% so far this year.

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