Lexicon Pharmaceuticals Announces Positive Topline Phase 1 Data for LX9211
December 05 2019 - 07:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced
positive topline data from the Phase 1 multiple ascending dose
study of LX9211, a potent oral small molecule inhibitor of adaptor
associated kinase 1 (AAK1), in development for the treatment of
neuropathic pain.
"We are pleased that the initial clinical data
for LX9211 in the multiple ascending dose study supports continued
advancement of the drug," said Praveen Tyle, Ph.D., executive vice
president of research and development at Lexicon. "LX9211 was well
tolerated with dose proportional pharmacokinetics, similar to what
was seen in the single ascending dose study. We expect to initiate
a proof-of-concept study for LX9211 early next year.”
The randomized, double-blind,
placebo-controlled, multiple ascending dose Phase 1 study was
performed to evaluate the safety, tolerability and pharmacokinetics
of orally administered LX9211 in healthy volunteers. The study was
comprised of five cohorts over a wide loading dose range of 25 mg
to 200 mg followed by a maintenance dose for 14 days. LX9211
demonstrated a favorable safety and pharmacokinetics profile
supportive of once-daily dosing and exhibited dose proportional
pharmacokinetics. The most common adverse events were headache and
dizziness, 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 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 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
telotristat ethyl, sotagliflozin 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, 2018, 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
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