Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that
clinical study results relating to LX9211, its investigational drug
for the treatment of diabetic peripheral neuropathic pain, and
INPEFA™ (sotagliflozin), its recently approved drug for heart
failure, will be featured as Oral Presentations focused on
treatment of complications of diabetes during the American Diabetes
Association’s 83rd Scientific Sessions, June 23-26, 2023, in San
Diego, California.
LX9211 has received Fast Track designation from
the U.S. Food and Drug Administration for development in diabetic
peripheral neuropathic pain, also known as DPNP.
On May 26, 2023, the FDA approved INPEFA, 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.
Details of the presentations are as follows:
- LX9211, an
Orally-Administered, Non-opioid, AAK1 Inhibitor for Painful
Diabetic Peripheral Neuropathy: Results from a Randomized,
Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter
Study – an oral presentation, Friday, June 23, 5:30-5:45
p.m. PT, San Diego Convention Center, Room 24, presented by Rodica
Pop-Busui, MD, PhD, Division of Metabolism, Endocrinology and
Diabetes, Department of Internal Medicine, University of Michigan,
Ann Arbor, MI
- The
Efficacy of Sotagliflozin on Heart-Failure Related Outcomes is
Independent of Baseline A1C – an oral presentation at the
ADA Presidents’ Select Abstract Session, Sunday, June 25, 2:45-3:00
p.m. PT, San Diego Convention Center, Room 5, presented by Rahul
Aggarwal, MD, Brigham & Women’s Hospital, Harvard Medical
School, Boston, MA
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 is
commercially launching one of these medicines, INPEFA™
(sotagliflozin), in the United States and has a pipeline of other
promising drug candidates in discovery and preclinical and clinical
development in neuropathic pain, diabetes and metabolism and other
indications. For additional information, please visit
www.lexpharma.com.
About LX9211
Discovered using Lexicon’s unique approach to
gene science, LX9211 is a potent, orally delivered, selective,
investigational small molecule inhibitor of adaptor-associated
kinase 1 (AAK1). Lexicon identified AAK1 in its target discovery
efforts as a promising approach for the treatment of neuropathic
pain and identified LX9211 and another development candidate in a
neuroscience drug discovery alliance with Bristol-Myers Squibb from
which Lexicon holds exclusive development and commercialization
rights. Preclinical studies of LX9211 demonstrated central nervous
system penetration and reduction in pain behavior in models of
neuropathic pain without affecting opiate pathways. LX9211 has
received Fast Track designation from the U.S. Food and Drug
Administration for development in diabetic peripheral neuropathic
pain.
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. Sotagliflozin 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) and LX9211. 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, 2022 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:Carrie
SiragusaLexicon Pharmaceuticals, Inc.csiragusa@lexpharma.com
For Media Inquiries:Alina
CocuzzaLexicon Pharmaceuticals, Inc.acocuzza@lexpharma.com
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