Lilly's Novel Diabetes Candidate Shows Promise in Phase II

Eli Lilly & Company LLY announced that its novel diabetes candidate led to significant reductions in blood sugar levels as well as body weight in type II diabetes patients.

Six month data from a phase IIb study demonstrated that the dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA) led to as much as 2.4% reduction in average HbA1c — a measure of blood glucose levels — as well as achieved significant weight loss of up to 12% (11.3 kg) in such patients.

The results were above management’s expectations. The company said that GIP/GLP-1 RA will be studied in a large phase III program to be called SURPASS. Phase III studies for type II diabetes are expected to begin early next year and be completed by 2021. The better-than-expected efficacy results also encouraged the company to consider studying GIP/GLP-1 RA for obesity and other conditions.

The candidate targets both the GIP and GLP-1 hormones and thus represents a novel treatment approach. It could hurt the prospects of currently marketed single-hormone drugs like Novo Nordisk’s NVO GLP-1 products Victoza and Omzepic. Other GLP-1 products available in the market are AstraZeneca’s AZN Bydureon/Byetta and Lilly’s Trulicity. The data was presented at the European Association for the Study of Diabetes meeting in Berlin.

Shares of Lilly were up more than 4% on Thursday in response to the positive news. So far this year, Lilly’s shares have outperformed the industry, rising 33.8% compared with an 8.1% increase for the industry.

 

 

However, in response to Lilly’s positive news, shares of Denmark’s Novo Nordisk declined 7.2%.

Lilly also presented full data from two label expansion studies in the EASE phase III program at the 54th EASD Annual Congress in Berlin. The EASE-2 and EASE-3 studies evaluated Lilly’s SGLT2 inhibitor, Jardiance (empagliflozin) as adjunct to insulin for adults with type I diabetes. In June, the company had announced that in both the studies, all investigated doses of empagliflozin (2.5, 10 and 25 mg) met their primary endpoint, which was change from baseline in A1C after 26 weeks of treatment. In the latest data presentation, Lilly provided several encouraging updates.

While the EASE-2 study (n=720) evaluated doses of 10 and 25 mg of empagliflozin versus placebo over 52 weeks, the EASE-3 study (n=960) evaluated 2.5, 10, and 25 mg doses versus placebo over 26 weeks. In EASE-2, placebo-corrected mean change from baseline in A1C at week 26 was -0.54% and -0.53% for the 10 and 25 mg doses, respectively. In EASE-3, placebo-corrected mean change from baseline in A1C was ???0.28%-0.45% and -0.52% for 2.5 mg, 10 mg and 25 mg doses, respectively at week 26.

Lilly also said that empagliflozin treatment led to reduction in weight, decrease in blood pressure and total daily insulin dose, which were the secondary endpoints. A key secondary endpoint in the study was also met as treatment with empagliflozin did not cause increase in the risk of investigator-reported hypoglycemic events, including severe hypoglycaemia.

Overall, the EASE studies showed that empagliflozin together with insulin has the potential to help manage blood sugar levels better than insulin alone in type I diabetes patients. Following the positive data from the study, Lilly said that regulatory discussions have begun

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 better-ranked large-cap pharma company is Roche RHHBY with a Zacks Rank #1. Shares of Roche have gained 9.2% in the past six months.

Roche’s earnings estimates for both 2018 and 2019 have gone up 3.2% in the past 30 days.

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