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Post hoc evaluation of scientific knowledge from the SCORED trial introduced on the American Society of Nephrology Kidney Week 2022 annual scientific assembly, together with proof that:
- Sotagliflozin considerably decreased urine albumin-to-creatinine ratio (UACR)
- Sotagliflozin had favorable results on albuminuria development and regression from a better UACR class
THE WOODLANDS, Texas, Nov. 05, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) immediately introduced {that a} new put up hoc evaluation of outcomes from the SCORED Phase 3 outcomes trial of sotagliflozin, an investigational twin SGLT1 and SGLT2 inhibitor, was introduced on the American Society of Nephrology Kidney Week 2022 annual scientific assembly in Orlando, Florida.
“Sotagliflozin showed statistically significant reductions in UACR regardless of albuminuria status at baseline in the SCORED trial,” stated David Z.I. Cherney, M.D., Ph. D., Professor within the Department of Medicine on the University of Toronto, and a member of the Steering Committee for the SCORED trial. “These reductions led to a 26% relative risk reduction for progression to a higher category of albuminuria, and a 34% relative increase in regression to a lower category of albuminuria, which are clinically meaningful outcomes for patients living with type 2 diabetes and chronic kidney disease.”
Dr. Cherney introduced the brand new evaluation at 10:00am ET immediately. The poster, “Effect of sotagliflozin on albuminuria in patients with type 2 diabetes and chronic kidney disease,” will be downloaded from the ASN web site.
The presence of albuminuria in sufferers with or with out diabetes is related to an elevated danger for antagonistic renal and cardiovascular outcomes. Urine albumin-to-creatinine ratio is usually used as a surrogate to evaluate kidney danger.
“We are pleased that data from the SCORED trial continue to yield robust findings that further help characterize the potential benefits of sotagliflozin,” stated Dr. Craig Granowitz, Lexicon’s senior vice chairman and chief medical officer.
About the SCORED Study
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 research evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to plain of care in 10,584 sufferers with sort 2 diabetes, persistent kidney illness with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface space, and dangers for heart problems. The major endpoint was the whole quantity of occasions comprised of deaths from cardiovascular causes, hospitalizations for coronary heart failure, and pressing visits for coronary heart failure in sufferers handled with sotagliflozin in contrast with placebo. Key secondary endpoints included whole quantity of occasions of deaths from cardiovascular causes, non-fatal myocardial infarction, and non-fatal stroke.
SCORED achieved its major endpoint, with total tolerability much like placebo. Results had been introduced on the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and concurrently revealed in The New England Journal of Medicine (NEJM) in an article titled: “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease”, which can be accessed at www.nejm.org.
About Sotagliflozin
Discovered utilizing Lexicon’s distinctive method to gene science, sotagliflozin is an investigational oral twin inhibitor of two proteins answerable for glucose regulation often called sodium-glucose co-transporter varieties 1 and a pair of (SGLT1 and SGLT2). SGLT1 is answerable for glucose absorption within the gastrointestinal tract, and SGLT2 is answerable for glucose reabsorption by the kidney. Sotagliflozin has been studied in a number of affected person populations encompassing coronary heart failure, sort 1 and sort 2 diabetes, and persistent kidney illness in fourteen Phase 3 scientific research involving roughly 20,000 sufferers.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical firm with a mission of pioneering medicines that remodel sufferers’ lives. Through its Genome5000™ program, Lexicon scientists studied the position and performance of almost 5,000 genes and recognized greater than 100 protein targets with important therapeutic potential in a variety of ailments. Through the exact concentrating on of these proteins, Lexicon is pioneering the invention and growth of progressive medicines to securely and successfully deal with illness. Lexicon superior one of these medicines to market and has a pipeline of promising drug candidates in discovery and scientific and preclinical growth in coronary heart failure, neuropathic ache, diabetes and metabolism and different indications. For extra data, please go to www.lexpharma.com.
Safe Harbor Statement
This press launch incorporates “forward-looking statements,” together with statements regarding the analysis and scientific growth of, regulatory filings for, and potential therapeutic and industrial potential of sotagliflozin. In addition, this press launch additionally incorporates ahead trying statements regarding Lexicon’s monetary place and long-term outlook on its business, development and future working outcomes, discovery and growth of merchandise, strategic alliances and mental property, in addition to different issues that aren’t historic info or data. All forward-looking statements are based mostly on administration’s present assumptions and expectations and contain dangers, uncertainties and different essential elements, particularly together with Lexicon’s potential to fulfill its capital necessities, efficiently conduct preclinical and scientific growth and acquire needed regulatory approvals of sotagliflozin, LX9211 and its different potential drug candidates on its anticipated timelines, efficiently commercialize any merchandise for which it obtains regulatory approval, obtain its operational aims, get hold of patent safety for its discoveries and set up strategic alliances, in addition to extra elements regarding manufacturing, mental property rights, and the therapeutic or industrial worth of its drug candidates. Any of these dangers, uncertainties and different elements might trigger Lexicon’s precise outcomes to be materially completely different from any future outcomes expressed or implied by such forward-looking statements. Information figuring out such essential elements is contained beneath “Risk Factors” in Lexicon’s annual report on Form 10-Ok for the yr ended December 31, 2021, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to replace or revise any such forward-looking statements, whether or not consequently of new data, future occasions or in any other case.
For Investor Inquiries:
Mike Kelly
Lexicon Pharmaceuticals, Inc.
[email protected]
For Media Inquiries:
Alina Kolomeyer
Lexicon Pharmaceuticals, Inc.
[email protected]
