Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical
company with a mission of pioneering medicines that transform
patients’ lives, today announced a business and pipeline update at
the 42nd Annual J.P. Morgan Healthcare Conference taking place
January 8-12, 2024.
“Lexicon achieved major advancements in 2023 in
its business and pipeline of pharmaceutical innovations,” said
Lonnel Coats, chief executive officer and director of Lexicon. “We
gained FDA approval in heart failure for INPEFA® (sotagliflozin),
an important new drug created from our own discovery efforts, and
we advanced neuropathic pain drug candidate LX9211 into late-stage
development. We are working diligently to build on this success in
2024 as we focus on accelerating the launch of INPEFA, leveraging
its differentiated profile and recently-adopted guidelines in the
large, fast-growing and under-penetrated heart failure market, and
advancing the clinical program for LX9211 in diabetic peripheral
neuropathic pain (DPNP), where it has the potential to become the
first, new, non-opioid drug in over two decades. We are also
evaluating additional opportunities for partnership and growth
including life-cycle management potential for INPEFA in
hypertrophic cardiomyopathy (HCM).”
INPEFA Launch Positioned for
Acceleration in 2024 Lexicon continues to focus on
accelerating the launch of INPEFA, having recently strengthened and
evolved its commercial organization to be better placed for success
with recent leadership additions and a sales force in place of
approximately 150 cardiovascular specialty representatives focused
on high-volume prescribers and institutions. The company’s sales
force has succeeded in driving demand well ahead of filled
prescriptions in 2023 pending continuing progress in establishing
broader market access and reimbursement. Further improving and
expanding market access and reimbursement is a key area of focus in
2024, together with driving further prescription and prescriber
growth and achieving favorable formulary decisions among integrated
delivery networks (IDNs). Lexicon aims to significantly increase
market access coverage in the first half of 2024 and expects
continued prescription and net sales growth throughout the year,
accelerating in the second half of 2024. The company will also
focus on ensuring a strong ongoing awareness of INPEFA in the
medical community through medical publications
and congress presence.
Clinical Data and FDA Feedback Support
INPEFA Life Cycle Management Opportunity in HCMClinical
data from INPEFA’s heart failure studies and its unique mechanism
of inhibiting SGLT1 and SGLT2 support a life-cycle management
opportunity in HCM, a condition of high unmet need that affects
approximately one million people in the U.S. In discussions with
the FDA, Lexicon has aligned on a protocol for a single Phase 3
study that could support a supplemental New Drug Application (sNDA)
for an INPEFA label expansion encompassing patients with both
obstructive and non-obstructive HCM.
Exploration of Potential Path Forward in
Type 1 Diabetes Lexicon and the FDA agreed to pause the
pending proceedings relating to Lexicon’s request for an
administrative hearing on whether there were grounds for the FDA’s
previous denial of the NDA for sotagliflozin in type 1 diabetes in
order to engage in discussions, now underway, regarding a potential
path forward for the approval of sotagliflozin in type 1
diabetes.
LX9211 Late-Stage Development Underway,
with Potential to Be First New Non-Opioid Drug for DPNP in Over Two
DecadesAn estimated 20 million patients in the U.S.
experience neuropathic pain, and approximately 5 million patients
experience DPNP, with the current standard of care often inadequate
and involving undesirable side effects. LX9211 has the potential to
be the first non-opioid approach with a novel mechanism in over two
decades in this large, underserved market. LX9211 is distinguished
in having established clinical success versus placebo in its Phase
2 proof-of-concept study, an important achievement enabling
progression into late-stage development and pivotal studies. LX9211
is further distinguished in having achieved clinical success in a
study, aligned with how new DPNP drugs are likely to be used in
practice, in which patients were permitted to maintain one
stable-dose DPNP therapy (gabapentin, pregabalin or duloxetine)
without being forced to withdraw from therapies that, although
inadequate, may be providing benefit. Patient enrollment in the
PROGRESS Phase 2b study is now underway, with data anticipated in
Q2 2025.
Company to Present at J.P. Morgan
Healthcare Conference Thursday, January 11, 2024 at 10:30am PST
(1:30pm ET)Lonnel Coats, Lexicon’s chief executive
officer, will make a company presentation. Jeff Wade, Lexicon’s
president and chief financial officer, Tom Garner, Lexicon’s senior
vice president and chief commercial officer, and Craig Granowitz,
M.D., Ph.D., Lexicon’s senior vice president and chief medical
officer, will also participate.
A simultaneous webcast will be available in the
“Events” section of the Lexicon website at
www.lexpharma.com/events, and a recording of the webcast will be
available for two weeks following the original on-demand date.
INDICATIONINPEFA® 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
INFORMATIONDosing: 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 a history of serious
hypersensitivity reaction to INPEFA.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. INPEFA is not indicated for glycemic
control. 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.
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 safely and effectively treat disease. 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 clinical and preclinical
development in 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 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:
Lisa DeFrancesco Lexicon Pharmaceuticals,
Inc.lexinvest@lexpharma.com
For Media Inquiries:
Alina CocuzzaLexicon Pharmaceuticals,
Inc.acocuzza@lexpharma.com
Lexicon Pharmaceuticals (NASDAQ:LXRX)
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