Lexicon Pharmaceuticals Announces Positive Topline Clinical Data for LX9211
December 18 2018 - 7:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced
positive topline results from its Phase 1a study of LX9211, a
potent oral small molecule inhibitor of adaptor associated kinase
1, or AAK1, in development for the treatment of neuropathic pain.
"We are pleased that the initial clinical data
for LX9211 confirms the drug candidate’s preclinical profile," said
Praveen Tyle, Ph.D., executive vice president of Research and
Development at Lexicon. "LX9211 was well tolerated with predictable
pharmacokinetics. At doses tested, drug levels of LX9211 were at
biologically relevant concentrations and support the therapeutic
potential of this highly selective inhibitor of AAK1. We look
forward to initiating a multiple ascending dose study for LX9211 in
the first quarter of 2019.”
The Phase 1a study met its primary objectives,
demonstrating a favorable safety and tolerability profile in
healthy human subjects and identifying the maximum tolerated
dose.
The randomized, double-blind,
placebo-controlled, ascending single dose Phase 1a study was
performed to evaluate the safety, tolerability and pharmacokinetics
of orally administered LX9211 in healthy volunteers. The study was
comprised of 10 cohorts over a wide daily dose range of 5 mg to 200
mg. LX9211 demonstrated a favorable safety and pharmacokinetics
profile supportive of once-daily, or less frequent, dosing.
Pharmacokinetics were dose proportional over virtually all of the
dose range and exhibited a minimal food effect. The most common
adverse event was headache, and there were no drug-related serious
adverse events.
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 data demonstrated central nervous system penetration
and reduction in pain behavior in models of neuropathic pain.
Lexicon has exclusive research, development and commercialization
rights to LX9211 and additional compounds acting through AAK1.
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 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 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
XERMELO (telotristat ethyl), successfully conduct preclinical and
clinical development and obtain necessary regulatory approvals of
sotagliflozin, LX2761 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, 2017, 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:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate StrategyLexicon Pharmaceuticals(281)
863-3383klee@lexpharma.com
For Media Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Patient AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Jul 2023 to Jul 2024