Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced
topline results of RELIEF-PHN-1, its Phase 2 proof-of-concept study
of LX9211 in postherpetic neuralgia. LX9211 achieved a reduction in
average daily pain score (ADPS) of 2.42 from baseline at week 6
compared to a reduction of 1.62 in the placebo arm, with a placebo
adjusted difference of 0.80 (p=0.12). Although these results did
not reach statistical significance on the primary endpoint of the
study, overall study results demonstrated clear evidence of effect.
Separation of LX9211 from placebo on ADPS was seen at week 1 and
maintained consistently thereafter, with an average placebo
adjusted reduction over the 6 Week dosing period of 0.80 (p=0.03).
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/d64d9848-3c4c-43a5-a8d6-09b3b7123b6f
“These results in postherpetic neuralgia achieve
our goal for this small, 79-patient study of establishing clear
evidence of effect supporting the further development of LX9211 in
another neuropathic pain condition,” said Craig Granowitz, M.D.,
Ph.D., Lexicon’s senior vice president and chief medical officer.
“The RELIEF-PHN-1 study results are broadly consistent with the
results achieved in our positive Phase 2 study of LX9211 in painful
diabetic neuropathy (RELIEF-DPN-1) which enrolled over 300
patients. These results bolster our confidence in moving the LX9211
clinical program forward in hopes of delivering a potential
solution for neuropathic pain patients in need of additional
treatment options.”
Notably, the study included only the higher of
the two doses evaluated in RELIEF-DPN-1. The lower dose arm (100 mg
on Day 1 and 10 mg thereafter) in RELIEF-DPN-1 demonstrated
statistically significant results on ADPS and meaningfully better
tolerability than the higher (200 mg on Day 1 and 20 mg thereafter)
dose.
Adverse events observed were consistent with
previous studies, with dizziness as the most commonly reported and
the most frequently associated with patient dropouts from the
study. There were no serious adverse events or deaths reported in
the study.
A full analysis of the results from RELIEF-PHN-1
will be submitted for publication at an upcoming medical conference
and in a peer-reviewed journal.
LX9211 achieved significant and consistent
benefits in the treatment of painful diabetic neuropathy 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 Today’s Live Conference Call and
Webcast
Lexicon management will host a live conference
call and webcast at 5:00 pm ET to discuss the study results. The
dial-in number for the conference call is 1-888-317-6003 and the
conference ID for all callers is 2304275. 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 the RELIEF-PHN-1
Study
RELIEF-PHN 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 post-herpetic 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 painful diabetic neuropathy, also referred to as
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 clinical
development and results of, regulatory filings for 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 Investor Inquiries:
Carrie SiragusaLexicon Pharmaceuticals,
Inc.csiragusa@lexpharma.com
For Media Inquiries:
Alina KolomeyerLexicon Pharmaceuticals,
Inc.akolomeyer@lexpharma.com
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