Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that
full results from the RELIEF-DPN-1 trial of its investigational
drug LX9211 were presented at the 16th Annual Pain Therapeutics
Summit in Washington, D.C. The oral 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),” was delivered at 3:35pm ET today.
“LX9211 achieved the primary objective of this
study by reducing patients’ average daily pain,” said Dr. Anand
Patel, the Chief Medical Officer at Conquest Research, a principal
investigator in the RELIEF-DPN-1 trial, and presenter of the
results. “These final data demonstrate additional positive effects
of LX9211 on measures that are very meaningful to patients
suffering from painful diabetic neuropathy, including burning pain
and sleep interference, which have direct impact on patient quality
of life.”
Today’s presentation of full data from the
entire 11-week evaluation period, which included a 5-week placebo
run-off period following the initial 6-week treatment period,
showed consistent and statistically significant treatment-period
benefits in measures of particular importance in painful diabetic
neuropathy (also known as diabetic peripheral neuropathic pain) for
both dose arms compared to placebo, such as a reductions in burning
pain (p<0.001 and p=0.017, respectively) and interference of
pain in sleep (p=0.005 and p=0.002, respectively).
During the blinded 5-week placebo run-off
period, there was a gradual tapering of efficacy in both treatment
arms with no evidence of rebound pain or withdrawal symptoms. There
were no observed differences in treatment-emergent adverse events
between the treatment and placebo arms during the run-off period,
and no drug-related serious adverse events or deaths were reported
in the trial.
In topline results previously reported in June
2022, LX9211 achieved the primary endpoint of the trial by
demonstrating a statistically significant reduction from baseline
in average daily pain score (ADPS) at week 6 compared to placebo in
the low dose arm (100 mg initial single dose, followed by 10 mg
daily doses), and narrowly missed statistical significance in the
high dose arm (200 mg initial single dose, followed by 20 mg daily
doses).
“These results further support AAK1’s utility as
a potential new mechanism of action for neuropathic pain and the
rapid advancement of LX9211 into phase 3 development in painful
diabetic neuropathy, which we are planning to initiate in 2023,”
said Dr. Craig Granowitz, Lexicon’s senior vice president and chief
medical officer.
About Today’s Live Conference Call and
Webcast
Following Dr. Patel’s presentation, he will join
Lexicon management on a live conference call and webcast at 5:00pm
ET to discuss the study results. The dial-in number for the
conference call is 888-886-7786 and the conference ID for all
callers is 28989106. 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-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.
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, 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:
Mike KellyLexicon Pharmaceuticals,
Inc.mkelly@lexpharma.com
For Media Inquiries:
Alina KolomeyerLexicon Pharmaceuticals,
Inc.akolomeyer@lexpharma.com
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