Lexicon Announces Planned Advancement of LX9211 Into Late-Stage Development
June 23 2023 - 8:45PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced plans
to advance its investigational drug LX9211 into late-stage
development in a clinical program directed towards an
application for regulatory approval in diabetic peripheral
neuropathic pain, or DPNP. The first late-stage study will be a
Phase 2b dose optimization study, with start-up scheduled in the
third quarter of 2023 and the initiation of dosing expected in the
fourth quarter. The Phase 2b study includes an extension to run in
parallel with planned next-stage Phase 3 studies.
Details of the clinical program, which has been
designed to optimize opportunities for success, time, and
efficiency in satisfying regulatory requirements for approval, will
be shared in a Conference Call and Webcast on Monday, June 26,
2023, at 8:00 am ET.
“We are energized by our
interactions with the FDA and value the feedback we have received,
which has helped to inform the design of our clinical program for
LX9211,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice
president and chief medical officer. “We look forward to advancing
LX9211 towards regulatory approval for diabetic peripheral
neuropathic pain.”
LX9211 has received Fast Track designation from
the U.S. Food and Drug Administration for development in DPNP.
Conference Call and Webcast
Information
Lexicon management will hold a live conference
call and webcast Monday, June 26, 2023, at 8:00 am ET / 7:00 am CT.
The dial-in number for the conference call is 888-317-6003 and the
conference ID for all callers is 7186279. The live webcast and
replay may be accessed by visiting Lexicon’s website at
www.lexpharma.com/events. An archived version of the webcast will
be available on the website for 14 days.
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 treat diseases safely and effectively. Lexicon is
commercially launching one of these medicines, INPEFA™
(sotagliflozin), in the United States and has a pipeline of other
promising drug candidates in discovery and preclinical and clinical
development in neuropathic pain, diabetes and metabolism and other
indications. For additional information, please visit
www.lexpharma.com.
About LX9211
Discovered using Lexicon’s unique approach to
gene science, LX9211 is a potent, orally delivered, selective,
investigational small molecule inhibitor of adaptor-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. LX9211 has
received Fast Track designation from the U.S. Food and Drug
Administration for development in diabetic peripheral neuropathic
pain.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to the therapeutic and
commercial potential, research and clinical development and
regulatory status of LX9211. In addition, this press release also
contains forward looking statements relating to Lexicon’s financial
position and long-term outlook on its business, 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 commercialize INPEFA™
(sotagliflozin) on the timeline and/or at the prices currently
contemplated or at all, conduct preclinical and clinical
development and obtain necessary regulatory approvals of INPEFA (in
unapproved indications), LX9211 and its other 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, 2022 and other subsequent disclosure documents 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:Carrie
SiragusaLexicon Pharmaceuticals, Inc.csiragusa@lexpharma.com
For Media Inquiries:Alina
CocuzzaLexicon Pharmaceuticals, Inc.acocuzza@lexpharma.com
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