Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced
several upcoming Lexicon-supported data presentations related to
heart failure (HF), type 1 diabetes (T1D), and diabetic peripheral
neuropathic pain (DPNP). The oral presentations will be made at the
59th Annual Meeting of EASD, October 2-6, 2023, in Hamburg, Germany
and online.
Details of the presentations are as follows:
- LX9211 in individuals with painful diabetic peripheral
neuropathy: results from a randomised, double-blind,
placebo-controlled, parallel-group, multicentre study – an
oral presentation, Tuesday, October 3, 11:30 - 11:45 a.m. CEST,
Mumbai Hall and online, presented by Rodica Pop-Busui, MD, PhD, the
Larry D Soderquist Professor of Diabetes, Vice Chair of Clinical
Research Department of Internal Medicine, Director Clinical
Research, Caswell Diabetes Institute, University of Michigan.
- Factors associated with changes in beta hydroxybutyrate
with sotagliflozin in adults with type 1 diabetes – a
short oral discussion, Tuesday, October 3, 1:45 - 2:45 p.m., Short
Oral Event B and online, presented by Schafer Boeder, M.D.,
University of California, San Diego.
- Temporal shift in heart
failure medications prescribed to hospitalised patients with and
without diabetes in a large US integrated health system –
a short oral discussion, Wednesday, October 4, 2:00 - 3:00 p.m.
CEST, Short Oral Event D and online, presented by Craig Granowitz,
M.D., Ph.D., senior vice president and chief medical officer,
Lexicon Pharmaceuticals.
On May 26, 2023, the U.S. Food and Drug
Administration 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.
LX9211 has received Fast Track designation from
the U.S. Food and Drug Administration for development in DPNP.
Lexicon is preparing to advance LX9211 into late-stage development
in a clinical program directed towards an application for
regulatory approval in DPNP. The first late-stage study will be a
Phase 2b dose optimization study, with study planning underway and
initiation of dosing expected before the end of 2023. The Phase 2b
study includes an extension to run in parallel with planned
next-stage Phase 3 studies.
“We look forward to presenting relevant data
from the most advanced programs in Lexicon’s portfolio of approved
and investigational agents,” said Craig Granowitz, M.D., Ph.D.,
Lexicon’s senior vice president and chief medical officer. “These
presentations at EASD will help generate greater awareness of these
programs and their potential to help patients across various
therapeutic areas.”
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.
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 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.
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:Investor
RelationsLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com
For Media Inquiries:Alina
CocuzzaLexicon Pharmaceuticals, Inc.acocuzza@lexpharma.com
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