Lexicon Enrolls First Patient in Phase 2b Progress Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)
30 Novembre 2023 - 1:30PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that
it has enrolled the first patient in
PROGRESS (A
Phase 2b, Dose-ranging,
Randomized, Double-blind,
Placeb
O-controlled,
Parallel-
GRoup, Multic
Enter
Study with an Open-label Extension in
Patient
S with Diabetic Peripheral Neuropathic
Pain) studying LX9211, a potent, orally-delivered, selective,
investigational small molecule inhibitor of adaptor-associated
kinase 1 (AAK1).
PROGRESS will enroll adult patients with a
diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes
mellitus (T2DM) with moderate to severe DPNP. The primary endpoint
of PROGRESS is a reduction of Average Daily Pain Score (ADPS),
consistent with the primary endpoint achieved in the successful
RELIEF-DPN-1 Phase 2a proof-of-concept study and, informed by
regulatory feedback, the primary endpoint planned for Phase 3
studies of LX9211 in DPNP. The placebo-controlled treatment period
of PROGRESS is intended to identify the optimal dosing for Phase 3
studies. The open-label extension is expected to run in parallel
with planned next-stage Phase 3 studies, supporting long-term
safety requirements for regulatory approval.
“We are excited about the potential for LX9211
to become a safe and effective treatment for DPNP and pleased to be
moving this promising drug candidate into late-stage development
with the initiation of PROGRESS,” said Craig Granowitz, M.D.,
Ph.D., Lexicon’s senior vice president and chief medical officer.
“With no new, non-opioid drugs having been approved for the
treatment of neuropathic pain in over two decades, this is an area
where novel treatment options are urgently needed. We thank the
study sites and especially the patients for their participation in
this important scientific endeavor.”
Topline data from PROGRESS is expected to be
announced in Q2 2025.
LX9211 has previously received Fast Track
designation from the FDA for development in DPNP.
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 has
advanced multiple medicines to market and has a pipeline of
promising drug candidates in heart failure, 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) in heart failure 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 other 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:Lisa
DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com
For Media Inquiries:Alina
CocuzzaLexicon Pharmaceuticals, Inc.acocuzza@lexpharma.com
Lexicon Pharmaceuticals (NASDAQ:LXRX)
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