Data From Lexicon’s RELIEF-DPN 1 Phase 2 Study of LX9211 Published Today in Diabetes Care, a Peer-Reviewed Journal of the American Diabetes Association
2024年6月19日 - 9:00PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced
that Diabetes Care, the peer-reviewed journal of the American
Diabetes Association, has published a research paper on the
company’s Phase 2 RELIEF-DPN-1 clinical trial investigating LX9211
for the treatment of diabetic peripheral neuropathic pain (DPNP).
In the proof-of-concept RELIEF-DPN-1 study, the effects of
LX9211 were assessed over an 11-week evaluation period, which
included a six-week double-blind treatment period and a 5-week
single-blind safety follow-up period. The primary efficacy endpoint
under evaluation was the change from baseline to week 6 in average
daily pain score (ADPS), which was achieved for subjects
participating in the low-dose LX9211 arm. Patient reported outcomes
were improved in patients treated with LX9211 and LX9211 was
generally well tolerated.
As noted by the study authors, currently available therapies for
DPNP provide only modest pain relief, with fewer than half of
individuals achieving 50% reduction in pain severity. Additionally,
most people suffering from DPNP experience undesirable,
dose-limiting adverse events with existing therapies. And despite a
lack of supportive clinical evidence, many people with DPNP
continue to be treated with opioids as first-line therapy, leading
to very high associated risks and complications, including
death.
“Results observed in this study show that LX9211 may become an
efficacious treatment for moderate-to-severe pain due to DPNP.
These findings reflect a promising breakthrough in the clinical
management of DPNP, one of the strongest risk factors for mortality
in people with diabetes, and the leading cause of non-traumatic
amputation,” said Rodica Pop-Busui, MD, PhD, Division of
Metabolism, Endocrinology and Diabetes, Department of Internal
Medicine, University of Michigan, Ann Arbor, MI, and the lead
author of the research paper.
“We are grateful to the investigators, their research teams and
the people suffering from DPNP who participated in this important
study,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice
president and chief medical officer. “Their contributions have
enabled us to commence our large dose-ranging Phase 2b PROGRESS
trial, currently enrolling patients throughout the United
States.”
To learn about the PROGRESS trial please visit
diabeticpainstudy.com.
An abstract of a Lexicon-sponsored study entitled
"Patient-Reported Burden of Disease in Diabetic Peripheral
Neuropathic Pain—Learnings from In-depth Patient
Interviews—Substudy of RELIEF-DPN 1," will be presented at
the 84th Scientific Sessions of the American Diabetes Association
on Sunday, June 23, 2024, 12:30 - 1:30 p.m. ET, in the Poster Hall
(West A-4-B2), Board No. 484.
The research paper,
“Efficacy and Safety of LX9211 for Relief
of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1): Results of
a Double-blind, Randomized, Placebo-Controlled, Proof-of-Concept
Study,” can be accessed here.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of
pioneering medicines that transform patients’ lives. Through the
Genome5000™ program, Lexicon’s unique genomics target discovery
platform, 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
treat disease safely and effectively. Lexicon has commercially
launched one of these medicines, INPEFA® (sotagliflozin) in the
United States, and has a pipeline of other promising drug
candidates in discovery and clinical and preclinical development in
neuropathic pain, diabetes and metabolism and other
indications. For additional information, please
visit www.lexpharma.com.
About LX9211
Discovered using Lexicon’s unique approach to
gene science, LX9211 is a potent, orally delivered, selective,
investigational 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 development in diabetic peripheral neuropathic
pain.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to LX9211 and Lexicon’s
financial position and long-term outlook on its business, growth
and future operating results, discovery, development and
commercialization 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 commercialize INPEFA in heart failure, conduct
preclinical and clinical development and obtain necessary
regulatory approvals of sotagliflozin (in other indications),
LX9211, LX9851 and its other drug candidates on its anticipated
timelines, 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 products and 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, 2023 and other subsequent disclosure documents 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:
Lisa DeFrancescoLexicon Pharmaceuticals,
Inc.lexinvest@lexpharma.com
For Media Inquiries:
Alina CocuzzaLexicon Pharmaceuticals,
Inc.acocuzza@lexpharma.com
Lexicon Pharmaceuticals (NASDAQ:LXRX)
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Lexicon Pharmaceuticals (NASDAQ:LXRX)
過去 株価チャート
から 6 2023 まで 6 2024