Lexicon Announces Positive Top-Line Results From Phase 2 Proof-Of-Concept Study Of LX9211 In Painful Diabetic Neuropathy
June 29 2022 - 4:01PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced
top-line results of RELIEF-DPN-1, its Phase 2 proof-of-concept
study of LX9211 in painful diabetic neuropathy. LX9211 achieved the
primary endpoint of the study, demonstrating a statistically
significant reduction in average daily pain score (ADPS) at week 6
compared to placebo in the low dose arm with results that plateaued
in the high dose arm. Separation from placebo was seen
by week 1 in both dose arms, and the effect was consistent across
age, sex, concurrent use of medications for painful diabetic
neuropathy, and baseline pain score.
Patient reported outcomes (global impression of
change) were improved in patients treated with LX9211 compared to
placebo. Adverse events were more frequent in the LX9211 treatment
arms and at the higher dose, with the most common being dizziness,
headache and nausea. Nearly all adverse events were reported as
mild or moderate. There were no drug-related serious adverse events
reported in the study.
A full analysis of the results from RELIEF-DPN-1
will be submitted for publication at an upcoming medical conference
and in a peer-reviewed journal.
“The results of this study support the
translation of a potential new mechanism of action for neuropathic
pain and serve as a testament to the strength of Lexicon’s
science,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice
president and chief medical officer. “Our scientists were the first
to identify AAK1 as a novel target with potential for the treatment
of neuropathic pain, making an initial discovery in knockout mice,
validating that discovery in collaboration with Bristol-Myers
Squibb with small molecule inhibition of the target in animal
models, and now translating that discovery in this human clinical
proof-of-concept study. This is an important step towards bringing
the benefits of our science to patients, in an area where novel
targets are rare and there is a tremendous need for new
therapies.”
LX9211 is a potent, orally delivered, selective
small molecule inhibitor of AAK1, which preclinical studies have
shown to reduce 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
the development in diabetic peripheral neuropathic pain.
About the RELIEF-DPN-1
Study
RELIEF-DPN-1 is a Phase 2 randomized,
double-blind, placebo-controlled, parallel-group, multicenter study
evaluating the efficacy, safety and pharmacokinetics of LX9211 in
the treatment of painful diabetic neuropathy, also referred to as
diabetic peripheral neuropathic pain. The study enrolled 319
patients at approximately 40 U.S. clinical sites, evaluating three
treatment groups receiving placebo or one of two dosing regimens of
LX9211 (an initial dose of 100 mg followed by once-daily doses of
10 mg or an initial dose of 200 mg followed by once-daily doses of
20 mg). The primary efficacy endpoint under evaluation was the
change from baseline to week 6 in ADPS, based on the 11-point
numerical rating scale. The results of the study on the
primary endpoint showed a reduction from baseline in ADPS of 1.39
points in the low dose arm and 1.27 points in the high dose arm,
compared to 0.72 in the placebo arm.
The RELIEF-DPN-1 study is the first of two Phase
2 proof-of-concept studies evaluating LX9211 in neuropathic pain.
LX9211 is also under evaluation in RELIEF-PHN-1, a study in
patients with post-herpetic neuralgia, from which Lexicon is
targeting top-line results around the end of the third quarter of
2022.
About LX9211
Discovered using Lexicon’s unique approach to
gene science, LX9211 is a potent, orally delivered, selective 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
the development in diabetic peripheral neuropathic pain.
Conference Call and Webcast
Information
Lexicon management will hold a live conference
call and webcast on June 30, 2022 at 8:00 am ET / 7:00 am CT
to discuss the RELIEF-DPN-1 top-line results. The dial-in
number for the conference call is 888-886-7786 (U.S./Canada) or
416-764-8658 (international). The conference ID for all callers is
20954316. The live webcast and replay may be accessed by visiting
Lexicon’s website at www.lexpharma.com/events. An archived version
of the webcast will be available on the website for 14 days.
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 advanced
one of these medicines to market and has a pipeline of promising
drug candidates in discovery and clinical and preclinical
development 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 clinical
development of and potential therapeutic and commercial potential
of LX9211. In addition, this press release also contains forward
looking statements relating to the clinical development of,
regulatory filings for and potential therapeutic and commercial
potential of sotagliflozin and Lexicon’s other potential drug
candidates, as well as 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 conduct preclinical and clinical
development and obtain necessary regulatory approvals of
sotagliflozin, LX9211 and its other potential drug candidates on
its anticipated timelines, successfully commercialize any products
for which it obtains regulatory approval, 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, 2021, as 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 Inquiries:
Mike KellyLexicon Pharmaceuticals,
Inc.mkelly@lexpharma.com
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Apr 2024 to May 2024
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From May 2023 to May 2024