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Lexicon Pharma announces strong CV data for first-in-class sotagliflozin at the European Society of Cardiology’s annual meeting

The company will use data from the SOLOIST and SCORED trials as part of a new drug application later this year

US-based Lexicon Pharmaceuticals has announced further analyses on the cardiovascular benefits of its first-in-class candidate, sotagliflozin, at the European Society of Cardiology annual meeting.

Initial results from the pivotal phase 3 SOLOIST and SCORED trials were presented to the American Heart Association in November last year, but the company has released the new analyses at ESC in the build-up to its planned new drug application for sotagliflozin in heart failure later this year.

SOLOIST tested the compound versus placebo when added to standard of care for people with type 2 diabetes who had recently been hospitalised for worsening heart failure, while SCORED evaluated sotagliflozin against placebo when added to standard of care for people with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.

“Sotagliflozin robustly and significantly reduced heart failure hospitalisations, myocardial infarction and stroke,” said study chair Deepak Bhatt, from Brigham and Women's Hospital and Harvard Medical School. “Sotagliflozin also showed rapid and broad benefit across multiple cardiovascular endpoints. Although direct, head-to-head clinical comparisons have not been performed, the reductions in both MI and stroke observed with sotagliflozin appear greater than what has been published in meta-analyses of clinical data from selective SGLT2 inhibitors.”

The analyses concluded that sotagliflozin led to a 33% absolute risk reduction in the composite cardiovascular endpoint in type 2 diabetes patients with heart failure HF, and a 26% reduction in the composite cardiovascular endpoint in patients with type 2 diabetes and chronic kidney disease.

Sotagliflozin is an inhibitor of glucose regulation proteins SGLT1 and SGLT2 (sodium-glucose co-transporter types 1 and 2). They are responsible for glucose absorption in the gastrointestinal tract (SGLT1) and the kidney (SGLT2).

The drug is already approved in Europe as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes but has not yet been commercially launched.

Professor of Cardiology at the Université de Paris, Gabriel Steg, said: “Sotagliflozin is the only agent studied to date that has shown benefit in acute heart failure patients with therapy started following initial treatment or hospitalisation for heart failure. The study data illustrates the value of sotagliflozin as a potential new treatment option for heart failure patients with type 2 diabetes.”

Last month Lexicon announced revenues for the three months to 30 June of $9.2m and the appointment of a new chief medical officer, Craig Granowitz, previously CMO at Amarin and head of global medical affairs, human health at Merck & Co.

Article by
Hugh Gosling

25th August 2021

From: Research, Regulatory, Healthcare



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