Lexicon Pharmaceuticals Announces Commencement of Patient Dosing in RELIEF-DPN-1 Phase 2 Clinical Study of LX9211 in Patients...
September 04 2020 - 8:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today the
commencement of patient dosing with blinded study drug in
RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled,
multi-center clinical study of LX9211 for the treatment of diabetic
peripheral neuropathic pain. LX9211 is a potent oral small molecule
inhibitor of adaptor associated kinase 1 (AAK1).
“We are pleased to progress with patient dosing
in our first proof-of-concept study of LX9211, in patients with
diabetic peripheral neuropathic pain,” said Praveen Tyle, Ph.D.,
executive vice president of research and development. “Based on
preclinical data, we believe that LX9211 has the potential to
significantly reduce pain response without addictive properties
while offering a novel therapeutic approach to neuropathic pain
through inhibition of AAK1. We are preparing for an additional
Phase 2 study in post-herpetic neuralgia that is expected to
commence later this year and are evaluating opportunities in other
areas of neuropathic pain, based on promising results in multiple
preclinical models and a favorable Phase 1 clinical safety
profile.”
About the RELIEF-DPN-1
Study
RELIEF-DPN-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 diabetic peripheral neuropathic pain. The study is
designed to enroll approximately 300 patients at approximately 30
U.S. clinical sites. The primary efficacy endpoint under evaluation
is the change from baseline (Day 1) to Week 6 in Average Daily Pain
Score (ADPS), based on the 11-point numerical rating scale
(NRS).
About LX9211
LX9211 is a potent, orally delivered, selective
small molecule inhibitor of AAK1, a target discovered and
extensively characterized in an alliance with Bristol Myers Squibb.
Preclinical studies of LX9211 demonstrated central nervous system
penetration and reduction in pain behavior in models of neuropathic
pain without affecting opiate pathways. Lexicon holds exclusive
research, development and commercialization rights to LX9211 and
additional compounds acting through AAK1 under the alliance.
About Lexicon
Pharmaceuticals
Lexicon is a fully integrated 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. In addition to its first commercial product,
XERMELO®, Lexicon has a pipeline of promising drug candidates in
clinical and preclinical development in diabetes and metabolism,
oncology and neuropathic pain. For additional information, please
visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s long-term
outlook on its business and the clinical development and potential
therapeutic and commercial potential of LX9211. In addition, this
press release also contains forward looking statements relating to
Lexicon’s 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 XERMELO (telotristat
ethyl), successfully conduct preclinical and clinical development
and obtain necessary regulatory approvals of telotristat ethyl,
sotagliflozin, LX9211 and its other potential 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 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, 2019, 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:
Chas SchultzExecutive Director, Corporate
Communications and Patient AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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