Lexicon Pharmaceuticals Receives Fast Track Designation From the FDA for LX9211 for Diabetic Peripheral Neuropathic Pain
December 11 2020 - 7:37AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today that
it has received Fast Track designation from the U.S. Food and Drug
Administration (FDA) for the development of LX9211 in diabetic
peripheral neuropathic pain.
“The FDA’s Fast Track designation of LX9211
reflects the serious unmet medical need of people suffering from
diabetic peripheral neuropathic pain,” said Praveen Tyle, Ph.D.,
executive vice president of research and development. “We look
forward to working closely with the FDA throughout the clinical
development process to bring this potential new innovative
treatment to patients as quickly as possible.”
Lexicon is currently enrolling patients with
diabetic peripheral neuropathic pain in a Phase 2 proof-of-concept
study of LX9211 and is preparing to initiate a second Phase 2
clinical trial of LX9211 in post-herpetic neuralgia.
The FDA’s Fast Track designation is designed to
facilitate the development and expedite the review of drugs that
are being developed to treat serious conditions and fill unmet
medical needs. The purpose of the designation is to expedite the
timeline for bringing important new drugs to patients. Programs
receiving Fast Track designation may benefit from early and
frequent interactions with the FDA over the course of drug
development. In addition, the Fast Track designation program
provides eligibility for accelerated approval and priority review
if relevant criteria are met and enables sponsors to submit
individual sections of a New Drug Application (NDA) for review on a
rolling-submission basis.
About LX9211
LX9211 is a potent, orally delivered, selective
small molecule inhibitor of adapter-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.
About Lexicon
Pharmaceuticals
Lexicon is a 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. Lexicon advanced
one of these medicines to market and has a pipeline of promising
drug candidates in discovery and clinical and preclinical
development in neuropathic pain, heart failure, diabetes and
metabolism and other indications. For additional information,
please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s financial
position, long-term outlook on its business and the clinical
development and therapeutic and commercial potential of its drug
candidates. 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 Lexicon’s ability to meet its
capital requirements, successfully conduct preclinical and clinical
development and obtain necessary regulatory approvals of LX9211,
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, 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 Investor RelationsLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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