Lexicon Pharmaceuticals Highlights Scientific and Medical Presentations Relating to Its Successful Phase 2 Proof-Of-Concept Study of LX9211 in Painful Diabetic Neuropathy
September 20 2022 - 8:59AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced a
series of scientific and medical presentations describing the
progression of its investigational drug LX9211 from discovery to
translation in a clinical proof-of-concept study.
- A poster was presented and an oral
presentation was given on September 8th and 9th, respectively, at
the PAINWeek 2022 National Conference on Pain
Management in Las Vegas, Nevada.
- The poster and presentation, each
titled “LX9211, a Novel Therapeutic Approach to Treatment of
Neuropathic Pain,” described the mechanism of action of LX9211’s
novel target, adaptor-associated protein kinase 1 (AAK1), as well
as results from multiple preclinical models of neuropathic pain
after treatment with the potent AAK1 inhibitor LX9211.
- A poster will be presented today at
3:15pm ET at the IASP World Congress on Pain in
Toronto, Canada. (https://iaspworldcongress2022.org/)
- The poster, titled “Efficacy,
Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic
Peripheral Neuropathic Pain (RELIEF-DPN 1),” outlines the unique
study design, baseline patient characteristics, and the positive
results of the primary endpoint of the study.
- An oral presentation will be given
on November 14th at 3:35pm ET at Arrowhead’s Annual Pain
Therapeutics Summit in Washington, D.C.
(https://www.paintherapeuticsummit.com/)
- The presentation, titled “A Phase 2
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of
LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain
(RELIEF-DPN 1),” will discuss the framework of the trial, the
preclinical basis for the program, and a full analysis of the
results from this positive proof-of-concept study.
“We believe the successful translation of a
novel mechanism for the potential treatment of neuropathic pain
could be transformational for patients,” said Dr. Craig Granowitz,
Lexicon’s senior vice president and chief medical
officer. “We are excited to present these findings to
the medical and scientific community and expect to communicate
additional LX9211 clinical and preclinical data as they become
available. Based on these results, we will expeditiously advance
the clinical development of LX9211 for the treatment of neuropathic
pain, an area of significant unmet clinical need.”
About the RELIEF-DPN-1
Study
RELIEF-DPN-1 was 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
(p=0.007 versus placebo) in the low dose arm and 1.27 points
(p=0.030 versus placebo) in the high dose arm, compared to 0.72 in
the placebo arm. Under the statistical analysis plan for the study,
a p-value of less than 0.028 was considered statistically
significant.
The RELIEF-DPN-1 study was 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 fourth 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.
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
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