Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that
four data presentations related to sotagliflozin, an inhibitor of
two sodium glucose transport proteins (SGLT2 and SGLT1), will be
delivered during the American College of Cardiology 73rd Annual
Scientific Session & Expo being held April 6 - 8, 2024 in
Atlanta, Georgia, including results from a post-hoc evaluation of
the efficacy of sotagliflozin in reducing stroke events in patients
with type 2 diabetes, chronic kidney disease (CKD), and high
cardiovascular (CV) risk in the SCORED Phase 3 clinical trial.
“Following FDA’s 2023 approval of INPEFA®
(sotagliflozin) for heart failure (HF), researchers are adding to
the overall scientific understanding of sotagliflozin, including
clinical evidence of its ability to reduce the risk of stroke and
myocardial infarction (MI), or heart attack,” said Craig Granowitz,
M.D., Ph.D., Lexicon’s senior vice president and chief medical
officer.
Details of the presentations are as follows:
- Sotagliflozin Reduces Stroke Outcomes in Patients with
Diabetes and Chronic Kidney Disease – a moderated poster
presentation, Monday, April 8, 12:15 - 12:25 p.m. ET, Theater 8‚
presented by Rahul Aggarwal, M.D., Icahn School of Medicine at
Mount Sinai, New York, New YorkStudy researchers evaluated the
efficacy of sotagliflozin in reducing all-cause and cause-specific
stroke outcomes among patients with type 2 diabetes, CKD, and high
CV risk. In a post-hoc analysis of data from the 10,584 patients in
the SCORED Phase 3 clinical trial, 213 all-cause stroke events
occurred, including 29 (13.6%) fatal events. Sotagliflozin reduced
the risk of all-cause stroke by 34%, with 1.2 events per 100
patient-years in the sotagliflozin group and 1.8 events per 100
patient-years in the placebo group. Similarly, sotagliflozin
reduced the risk of ischemic stroke by 32%, with 0.8 events per 100
patient-years in the sotagliflozin group and 1.2 events per 100
patient-years in the placebo group.Click here to access additional
study details in the online abstract.
- Sotagliflozin, a Dual SGLT 1 and 2 Inhibitor, Modulated
Expression of Glucose Transport and Inflammatory Proteins in
Endothelial Cells following Angiotensin II Stimulation – a
poster presentation, Sunday, April 7, 1:15 – 2:00 p.m. ET,
1425-157, Hall B4-5, presented by Preston Mason, Ph.D. MBA, Elucida
Research, Beverly, MassachusettsStudy researchers found that
sotagliflozin modulated expression of proteins linked to the Akt
signaling pathway, glucose transport and vasodilation in human
endothelial cells exposed to an inflammatory stimulus
in vitro. The favorable endothelial cell actions of sotagliflozin
during inflammation add to the body of knowledge of sotagliflozin’s
mechanism of action and are consistent with the reduced
atherothrombotic risk demonstrated in outcome trials.Click here to
access additional study details in the online abstract.
- Sotagliflozin, a First-in-Class SGLT1/2 Inhibitor,
Inhibits Clotting Potential in the Vessel via Inhibition of
Platelet Activation, Integrin Activation, and Aggregation in Human
Platelets – a moderated poster presentation, Sunday, April
7, 11:30 - 2:40 a.m. ET, Theater 5‚ presented by Livia Stanger,
Ph.D. Candidate, University of Michigan, Ann Arbor, MichiganStudy
researchers found that sotagliflozin inhibits platelet activation
through simultaneously targeting SGLT1 and SGLT2. These findings
provide insight into the potential mechanism by which sotagliflozin
impacts stroke and MI risk in patients with type 2 diabetes and CKD
and provides a basis for further studies to explore the role of
sotagliflozin for CV protection in patients at increased risk for
ischemic events.Click here to access study details in the online
abstract.
- Temporal Shift in Heart Failure Medications Prescribed
to Hospitalized Patients According to Sex and Age. Results from Two
Large US Integrated Health Systems – a poster
presentation, Sunday, April 7, 9:15 – 10:00 a.m. ET, 1343-121, Hall
B4-5, presented by Mario Enrico Canonico, M.D., Ph.D., CPC Clinical
Research, University of Colorado, Aurora, ColoradoStudy researchers
found that substantial opportunity exists to further improve the
prescription of guideline-directed medical therapy (GDMT) for
patients with HF. Differences in timing of initiation of these
therapies by sex and age highlight the need to evaluate care gaps
by these and other determinants of health.Click here to access
additional study details in the online abstract.
On May 26, 2023, the U.S. Food and Drug
Administration approved INPEFA® (sotagliflozin), a once-daily oral
tablet, to reduce the risk of cardiovascular death, hospitalization
for heart failure, and urgent heart failure visit in adults
with:
- heart failure or
- type 2 diabetes mellitus, chronic
kidney disease, and other cardiovascular risk factors.
About Lexicon
Pharmaceuticals
Lexicon is a biopharmaceutical company with a
mission of pioneering medicines that transform patients’ lives.
Through its Genome5000™ program, Lexicon scientists studied the
role and function of nearly 5,000 genes and identified more than
100 protein targets with significant therapeutic potential in a
range of diseases. Through the precise targeting of these proteins,
Lexicon is pioneering the discovery and development of innovative
medicines to treat diseases safely and effectively. Lexicon has
advanced multiple medicines to market and has a pipeline of
promising drug candidates in heart failure, neuropathic pain,
diabetes and metabolism and other indications. For additional
information, please visit www.lexpharma.com.
About INPEFA®
(sotagliflozin)
Discovered using Lexicon’s unique approach to
gene science, INPEFA® (sotagliflozin) is an oral inhibitor of two
proteins responsible for glucose regulation known as sodium-glucose
cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible
for glucose reabsorption by the kidney and SGLT1 is responsible for
glucose absorption in the gastrointestinal tract. INPEFA has been
studied in multiple patient populations encompassing heart failure,
diabetes, and chronic kidney disease in clinical studies involving
approximately 20,000 patients.
INDICATION
INPEFA is indicated to reduce the risk of
cardiovascular death, hospitalization for heart failure, and urgent
heart failure visit in adults with:
- heart failure or
- type 2 diabetes mellitus, chronic
kidney disease, and other cardiovascular risk factors
IMPORTANT SAFETY
INFORMATION
Dosing: Assess renal function
and volume status and, if necessary, correct volume depletion prior
to initiation of INPEFA. INPEFA dosing for patients with
decompensated heart failure may begin when patients are
hemodynamically stable, including when hospitalized or immediately
upon discharge.
Contraindications: INPEFA is
contraindicated in patients with hypersensitivity to any
component.
Warnings and Precautions:
Ketoacidosis: INPEFA increases
the risk of ketoacidosis in patients with type 1 diabetes mellitus
(T1DM). Type 2 diabetes mellitus (T2DM) and pancreatic disorders
are also risk factors. The risk of ketoacidosis may be greater with
higher doses. There have been postmarketing reports of fatal events
of ketoacidosis in patients with type 2 diabetes using sodium
glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA,
assess risk factors for ketoacidosis. Consider ketone monitoring in
patients with T1DM and consider ketone monitoring in others at risk
for ketoacidosis, and educate patients on the signs/symptoms of
ketoacidosis. Patients receiving INPEFA may require monitoring and
temporary discontinuation of therapy in clinical situations known
to predispose to ketoacidosis.
Assess patients who present with signs and
symptoms of metabolic acidosis or ketoacidosis, regardless of blood
glucose level. If suspected, discontinue INPEFA, evaluate, and
treat promptly. Monitor patients for resolution of ketoacidosis
before restarting INPEFA.
Volume Depletion: INPEFA can
cause intravascular volume depletion which may sometimes manifest
as symptomatic hypotension or acute transient changes in
creatinine. There have been post-marketing reports of acute kidney
injury, some requiring hospitalization and dialysis, in patients
with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients
with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly
patients, or patients on loop diuretics may be at increased risk
for volume depletion or hypotension. Before initiating INPEFA in
patients with one or more of these characteristics, assess volume
status and renal function, and monitor for signs and symptoms of
hypotension during therapy.
Urosepsis and Pyelonephritis:
Treatment with SGLT2 inhibitors, including INPEFA, increases the
risk for urinary tract infections. Serious urinary tract infections
including urosepsis and pyelonephritis requiring hospitalization
have been reported. Evaluate patients for signs and symptoms of
urinary tract infections and treat promptly.
Hypoglycemia with Concomitant Use with
Insulin and Insulin Secretagogues: Insulin and insulin
secretagogues are known to cause hypoglycemia. INPEFA may increase
the risk of hypoglycemia when combined with insulin or an insulin
secretagogue. Therefore, a lower dose of insulin or insulin
secretagogue may be required to minimize the risk of hypoglycemia
when used with INPEFA.
Necrotizing Fasciitis of the Perineum
(Fournier’s Gangrene): Reports of Fournier’s Gangrene, a
rare but serious and life-threatening necrotizing infection
requiring urgent surgical intervention, have been identified in
post-marketing surveillance in patients with diabetes mellitus
receiving SGLT2 inhibitors. Assess patients who present with pain,
tenderness, erythema, or swelling in the genital or perineal area,
along with fever or malaise. If suspected, start treatment
immediately with broad-spectrum antibiotics and, if necessary,
surgical debridement. Discontinue INPEFA, closely monitor patient
signs and symptoms, and provide appropriate alternative therapy for
heart failure.
Genital Mycotic Infections:
INPEFA increases the risk of genital mycotic infections. Monitor
and treat as appropriate.
Urinary Glucose Test and
1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable
for patients taking SGLT2 inhibitors. Use alternative testing
methods to monitor glucose levels.
Common Adverse Reactions: the
most commonly reported adverse reactions (incidence ≥ 5%) were
urinary tract infection, volume depletion, diarrhea, and
hypoglycemia.
Drug Interactions:
- Digoxin: Monitor patients appropriately as
there is an increase in the exposure of digoxin when coadministered
with INPEFA 400 mg.
- Uridine 5'-diphospho-glucuronosyltransferase (UGT)
Inducer: The coadministration of rifampicin, an inducer of
UGTs, with sotagliflozin resulted in a decrease in the exposure of
sotagliflozin.
- Lithium:
Concomitant use of an SGLT2 inhibitor with lithium may decrease
serum lithium concentrations. Monitor serum lithium concentration
more frequently during INPEFA initiation and with dosage
changes.
Use in Specific Populations:
- Pregnancy and Lactation: INPEFA is not
recommended during the second and third trimesters of pregnancy,
nor while breastfeeding.
- Geriatric Use: No INPEFA dosage change is
recommended based on age. No overall differences in efficacy were
detected between these patients and younger patients, and other
reported clinical experience has not identified differences in
responses between the elderly and younger patients, but greater
sensitivity of some older individuals cannot be ruled out. Elderly
patients may be at increased risk for volume depletion adverse
reactions, including hypotension.
- Renal Impairment: INPEFA was evaluated in
patients with chronic kidney disease (eGFR 25 to
60 mL/min/1.73 m2) and in patients with heart failure with
eGFR <60 mL/min/1.73 m2. The safety profile of INPEFA
across eGFR subgroups in these studies was consistent with the
known safety profile. There was an increase in volume-related
adverse events (e.g., hypotension, dizziness) in patients with eGFR
<30 mL/min/1.73m2 relative to the overall safety
population. Efficacy and safety studies with INPEFA did not enroll
patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis.
After starting therapy in the studies, patients were discontinued
if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic
dialysis.
- Hepatic Impairment: INPEFA is not recommended
in patients with moderate or severe hepatic impairment.
Click here for full Prescribing
Information.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to the therapeutic and
commercial potential, research and clinical development and
regulatory status of INPEFA® (sotagliflozin). In addition, this
press release also contains forward looking statements relating to
Lexicon’s financial position and long-term outlook on its business,
growth and future operating results, discovery and development of
products, strategic alliances and intellectual property, as well as
other matters that are not historical facts or information. All
forward-looking statements are based on management’s current
assumptions and expectations and involve risks, uncertainties and
other important factors, specifically including Lexicon’s ability
to meet its capital requirements, successfully commercialize INPEFA
in heart failure on the timeline and/or at the prices currently
contemplated or at all, conduct preclinical and clinical
development and obtain necessary regulatory approvals of INPEFA (in
other indications), LX9211 and its other drug candidates on its
anticipated timelines, achieve its operational objectives, obtain
patent protection for its discoveries and establish strategic
alliances, as well as additional factors relating to manufacturing,
intellectual property rights, and the therapeutic or commercial
value of its drug candidates. Any of these risks, uncertainties and
other factors may cause Lexicon’s actual results to be materially
different from any future results expressed or implied by such
forward-looking statements. Information identifying such important
factors is contained under “Risk Factors” in Lexicon’s annual
report on Form 10-K for the year ended December 31, 2023 and other
subsequent disclosure documents filed with the Securities and
Exchange Commission. Lexicon undertakes no obligation to update or
revise any such forward-looking statements, whether as a result of
new information, future events or otherwise.
For Investor Inquiries:Lisa
DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com
For Media Inquiries:Alina
CocuzzaLexicon Pharmaceuticals, Inc.acocuzza@lexpharma.com
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