The Woodlands, Texas, January 14, 2021 – Lexicon Prescription drugs, Inc. (Nasdaq: LXRX) introduced right now that it has acquired U.S. Meals and Drug Administration (FDA) regulatory suggestions that the outcomes of its SOLOIST and SCORED Section three scientific research can assist a brand new drug software (NDA) submission for a sign to cut back the danger of cardiovascular demise, hospitalization for coronary heart failure, and pressing visits for coronary heart failure in grownup sufferers with kind 2 diabetes with both worsening coronary heart failure or extra threat components for coronary heart failure.
The suggestions was supplied in response to a request made by Lexicon following the completion of the SOLOIST and SCORED research referring to the potential submission of an NDA primarily based on the outcomes of such research, taking into consideration their early close-out and different issues. This regulatory suggestions clears a key hurdle for partnership discussions round sotagliflozin in coronary heart failure and allows a possible NDA submitting in 2021.
Lonnel Coats, Lexicon’s president and chief government officer, will current on the 39th Annual J.P. Morgan Healthcare Convention right now at 2:50 p.m. ET. A webcast of the occasion will likely be out there within the “Occasions” part of the Lexicon web site at
In regards to the SOLOIST and SCORED Research
SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Section three research evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to straightforward of care in 1,222 sufferers with kind 2 diabetes who had not too long ago been hospitalized for worsening coronary heart failure. The first endpoint was the overall variety 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.
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Section three research evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to straightforward of care in 10,584 sufferers with kind 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 first endpoint was the overall variety 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.
Each SOLOIST and SCORED achieved their respective major endpoints. Outcomes from each research had been introduced on the Late-Breaking Science Session of the American Coronary heart Affiliation (AHA) Scientific Periods 2020 and concurrently printed in The New England Journal of Drugs (NEJM) in two separate articles titled: “Sotagliflozin in Sufferers with Diabetes and Latest Worsening Coronary heart Failure” and “Sotagliflozin in Sufferers with Diabetes and Persistent Kidney Illness.”
Found utilizing Lexicon’s distinctive strategy to gene science, sotagliflozin is an oral twin inhibitor of two proteins liable for glucose regulation generally known as sodium-glucose co-transporter varieties 1 and a pair of (SGLT1 and SGLT2). SGLT1 is liable for glucose absorption within the gastrointestinal tract, and SGLT2 is liable for glucose reabsorption by the kidney. Sotagliflozin is authorized within the European Union (EU) to be used as an adjunct to insulin remedy to enhance blood sugar (glycemic) management in adults with kind 1 diabetes with a physique mass index ≥ 27 kg/m2, who couldn’t obtain sufficient glycemic management regardless of optimum insulin remedy, however has not but been commercially launched.
About Lexicon Prescription drugs
Lexicon is a biopharmaceutical firm with a mission of pioneering medicines that rework sufferers’ lives. By way of its Genome5000™ program, Lexicon scientists studied the function and performance of practically 5,000 genes and recognized greater than 100 protein targets with important therapeutic potential in a variety of illnesses. By way of the exact concentrating on of those proteins, Lexicon is pioneering the invention and growth of modern medicines to soundly and successfully deal with illness. Lexicon superior one in all these medicines to market and has a pipeline of promising drug candidates in discovery and scientific and preclinical growth in neuropathic ache, coronary heart failure, diabetes and metabolism and different indications. For extra info, please go to
Secure Harbor Assertion
This press launch incorporates “forward-looking statements,” together with statements referring to Lexicon’s scientific growth of and regulatory filings for sotagliflozin, partnership discussions referring to sotagliflozin and the potential therapeutic and industrial potential of sotagliflozin, in addition to Lexicon’s monetary place and long-term outlook on its enterprise, together with the scientific growth of, regulatory filings for, and potential therapeutic and industrial potential of its different drug candidates. As well as, this press launch additionally incorporates ahead trying statements referring to Lexicon’s development and future working outcomes, discovery and growth of merchandise, strategic alliances and mental property, in addition to different issues that aren’t historic information or info. All forward-looking statements are primarily based on administration’s present assumptions and expectations and contain dangers, uncertainties and different necessary components, particularly together with Lexicon’s means to satisfy its capital necessities, efficiently conduct preclinical and scientific growth and acquire needed regulatory approvals of LX9211, sotagliflozin and its different potential drug candidates on its anticipated timelines, obtain its operational targets, acquire patent safety for its discoveries and set up strategic alliances, in addition to extra components referring to manufacturing, mental property rights, and the therapeutic or industrial worth of its drug candidates. Any of those dangers, uncertainties and different components might trigger Lexicon’s precise outcomes to be materially completely different from any future outcomes expressed or implied by such forward-looking statements. Data figuring out such necessary components is contained underneath “Threat Elements” in Lexicon’s annual report on Type 10-Ok for the yr ended December 31, 2019, as filed with the Securities and Alternate Fee. Lexicon undertakes no obligation to replace or revise any such forward-looking statements, whether or not on account of new info, future occasions or in any other case.
Supply: Lexicon Prescription drugs
Posted: January 2021
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