Eli Lilly and Company (LLY - Free Report) presented additional data from two phase III studies — PRONTO-T1D and PRONTO-T2D — evaluating its investigational ultra-rapid-acting lispro (URLi) for the treatment of type I and type II diabetesat the scientific session of the American Diabetes Association (ADA).
In October last year, Lilly had announced that the studies met the primary efficacy endpoint. Data presented from the studies showed that URLi was non-inferior to Humalog in controlling A1C (an overall measure of glucose control) while significantly lowering post meal blood glucose levels in type I and type II diabetes patients.
Lilly confirmed these observations along with the latest release and also said that treatment with URLi led to superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. The data also showed that URLi significantly improved glucose time in range during the day. The data thus indicates that URLi may help control blood glucose post meals, thereby addressing a concern for patients taking mealtime insulin who experience high blood glucose levels after eating
Lilly has submitted regulatory applications for URLi based on data from these studies in Europe and Japan. It plans to submit the same in the United States later this year.
Lilly’s shares have risen 2.2% this year so far compared with the industry’s increase of 1.7%.
At ADA, Lilly also presented data from an outcomes study (REWIND) on Trulicity, which showed that the GLP-1 receptor agonist led to a 12% reductionin cardiovascular events like CV death, non-fatal myocardial infarction (heart attack) or non-fatal stroke in a broad range of type II diabetes patients.
Importantly, only 31% of the participants in the REWIND study had established CV disease compared to other CV outcomes studies, which have a much greater percentage of type II diabetes patients already with a heart disease. The statistically significant heart risk reduction shown by Trulicity in the study demonstrates that the drug may be able to cater to a much broader patient population if the data is approved to be included on the label. Regulatory applications are already under review in the United States and Europe seeking approval to include REWIND data on Trulicity's label.
At ADA, Lilly also presented new data from a study on tirzepatide, Lilly’s dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), which reinforced tirzepatide's potential to meaningfully reduce A1C and body weight in type II diabetes patients.
Other big pharma companies like Sanofi (SNY) and Novo Nordisk (NVO), which also hold a strong position in the diabetes market, made data presentations from key diabetes studies at ADA. Other important players in the diabetes market are AstraZeneca, Bristol-Myers and Merck (MRK).
Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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