Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that
results from RELIEF-PHN-1, a Phase 2 double-blind,
placebo-controlled trial of its investigational drug LX9211 for the
treatment of postherpetic neuralgia, will be presented during the
Emerging Science session at the AAN Annual Meeting, April 22-27, in
Boston, MA:
RELIEF-PHN-1: A Phase 2
Double-Blind, Randomized, Placebo-Controlled Trial of LX9211 in the
Treatment of Postherpetic Neuralgia Pain - an oral presentation and
poster (004), Monday April 24, 11:33-11:39 a.m. ET, Boston
Convention and Exhibition Center, presented by Anand Patel, MD,
Conquest Research, Winter Park, FL
Lexicon also announced that study investigators
will present LX9211 clinical trial data at the BPS 56th Annual
Scientific Meeting, May 9-11, in Glasgow, UK:
Topline Results from RELIEF-PHN-1:
A Phase 2 Double-Blind, Placebo-Controlled Trial of LX9211 in the
treatment of Postherpetic Neuralgia Pain, Tuesday May 9, 4:05-5:05
p.m. BST, Glasgow, Scotland, UK, presented by Suma Gopinathan, PhD,
Lexicon Pharmaceuticals, The Woodlands, TX
Topline results from RELIEF-PHN-1 were announced in
December 2022 providing further evidence of LX9211’s potential as
an effective non-opioid treatment for neuropathic pain. LX9211
achieved significant and consistent benefits in the treatment of
diabetic peripheral neuropathic pain in the RELIEF-DPN-1 study,
from which full results were presented in November 2022. LX9211 has
received Fast Track designation from the U.S. Food and Drug
Administration for development in diabetic peripheral neuropathic
pain.
About the RELIEF-PHN-1 Study
RELIEF-PHN-1 was a Phase 2 randomized,
double-blind, placebo-controlled, parallel-group, multicenter study
evaluating the efficacy and safety of LX9211 in the treatment of
postherpetic neuralgia. The study enrolled 79 patients at 32
clinical sites. The primary efficacy endpoint under evaluation was
the change from baseline (Day 1) to Week 6 in Average Daily Pain
Score (ADPS), based on the 11- point numerical rating scale.
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 diabetic peripheral neuropathic pain. The study
enrolled 319 patients at 45 U.S. clinical sites, evaluating three
treatment groups receiving placebo or one of two dosing regimens of
LX9211 (an initial single dose of 100 mg followed by once-daily
doses of 10 mg, or an initial single 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.
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 research and
clinical development of, regulatory filings for, and potential
therapeutic and commercial potential of 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 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, 2022, 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 Investor Inquiries:
Carrie SiragusaLexicon Pharmaceuticals,
Inc.csiragusa@lexpharma.com
For Media Inquiries:
Alina Cocuzza (Kolomeyer)Lexicon
Pharmaceuticals, Inc.akolomeyer@lexpharma.com
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