Biopharmaceutical company Lexicon Pharmaceuticals Inc. (LXRX:NASDAQ) yesterday announced "that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo."
The firm reported that in the Phase 3 SOLOIST study it successfully met the primary endpoint, which was identified as a hazard ratio (HR) of 0.67 in patients with both type 2 diabetes and a recent hospitalization for worsening heart failure. The company stated it also recorded positive results in the Phase 3 SCORED study and met that primary endpoint as well, which was a HR of 0.74 in subjects with both type 2 diabetes and chronic kidney disease.
Lexicon Pharmaceuticals indicated that it presented that key results from the SOLOIST and SCORED studies yesterday at American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published the results in two separate articles in The New England Journal of Medicine.
Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and professor of medicine at Harvard Medical School and study chair and lead author for the NEJM publications of the SOLOIST and SCORED results. commented, "Cardiovascular disease continues to be a leading cause of death in people with type 2 diabetes...SOLOIST demonstrates that early, in-hospital initiation of sotagliflozin in patients with worsening heart failure significantly reduces subsequent cardiovascular events, an effect that was consistent across groups with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). SCORED demonstrates that sotagliflozin significantly reduces heart failure events in a patient population with stage 3 and 4 chronic kidney disease and cardiovascular risk. Both studies add to the evidence that SGLT2 inhibition should be standard of care in heart failure, and the SCORED data reflecting a reduction in myocardial infarction and stroke and better glucose control in CKD patients suggest potential benefits from the dual SGLT1 and SGLT2 mechanism of this particular agent."
The company explained that the multi-center SOLOIST Phase 3 study included 1,222 patients with type 2 diabetes who had been hospitalized recently for worsening heart failure. The firm advised that "the primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients starting treatment with 200 mg sotagliflozin once daily compared with placebo, with dosing initiated either before or within 3 days of hospital discharge."
The firm noted that the Phase 3 SCORED study included 10,584 patients with type 2 diabetes and chronic kidney disease who were determined to be at risk for cardiovascular disease. In the SCORED study, cardiovascular efficacy of sotagliflozin was evaluated versus placebo when added to existing standard of care. The established primary endpoint was "the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo."
The company explained that sotagliflozin was first discovered using its unique approach to gene science. The firm stated that "sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney."
Lexicon is a biopharmaceutical company headquartered in The Woodlands, Tex. The firm stated that "through its Genome5000™ program, its scientists studied the role and function of nearly 5,000 genes and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases." Lexicon indicated that it has a pipeline of drug candidates in clinical and preclinical development in diabetes and metabolism and neuropathic pain. The firm also has a milestone and royalty interest in oncology.
Lexicon Pharmaceuticals began the day with a market capitalization of around $151.5 million with approximately 117.5 million shares outstanding and a short interest of about 8.2%. LXRX shares opened 74% higher today at $2.25 (+$0.96, +74.42%) over yesterday's $1.29 closing price. The stock has traded today between $1.71 and $2.38 per share and closed at $1.81 (+$0.52, +40.31%).[NLINSERT]
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