THE WOODLANDS, Texas,
Sept. 27, 2017 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today
announced the company has initiated dosing in a Phase 1 study of
LX9211, an orally-administered small molecule for the treatment of
neuropathic pain. LX9211 is a selective inhibitor of AAK1
(adapter-associated kinase), which in preclinical studies
demonstrated significant reduction in pain response in a series of
pain models and was well-tolerated at and above efficacious doses
in animals.
"The successful filing of the IND followed by initiation of the
first-in-human clinical study for LX9211 are significant milestones
for the company as these events validate our robust preclinical
results and bring us closer to demonstrating clinical
proof-of-concept for LX9211 in patients with neuropathic pain,"
said Praveen Tyle, Ph.D., Lexicon's
executive vice president, research and development. "Based on
animal data, LX9211 has the potential to significantly reduce pain
response while offering a novel therapeutic approach to neuropathic
pain through inhibition of AAK1. We look forward to producing
important early data to guide our future development plans."
The Phase 1 double-blind, placebo-controlled, single ascending
dose study for LX9211 is designed to assess the safety,
tolerability and pharmacokinetics of LX9211 across nine oral
escalating dose levels (5 mg to 300 mg) in healthy volunteers.
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company that is
applying a unique approach to gene science based on Nobel
Prize-winning technology to discover and develop precise medicines
for patients with serious, chronic conditions. Through its
Genome5000™ program, Lexicon scientists have studied the role and
function of nearly 5,000 genes over the last 20 years and have
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® (telotristat ethyl), Lexicon has a
pipeline of promising drug candidates in clinical and pre-clinical
development in diabetes and metabolism 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 clinical development of
and regulatory filings for LX9211 and the results and projected
timing of clinical trials and the 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 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 the risk that
clinical studies of LX9211 may be halted, delayed or otherwise not
demonstrate safety or efficacy, the risk that the FDA and other
regulatory authorities may not grant regulatory approval of LX9211
in accordance with Lexicon's currently anticipated timelines or at
all, and the risk that such regulatory approvals, if granted, may
have significant limitations on the approved use of LX9211. As a
result, LX9211 may never be successfully commercialized. Other
risks include Lexicon's ability to meet its capital requirements,
successfully commercialize its approved product, conduct
preclinical and clinical development and obtain necessary
regulatory approvals of its other potential drug candidates,
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,
2016, 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.
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SOURCE Lexicon Pharmaceuticals, Inc.