Lexicon Pharmaceuticals Announces Topline Phase 1 Clinical Results for LX2761 in Diabetes
December 20 2018 - 7:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced
topline results from Phase 1 clinical studies of LX2761, an oral
sodium-glucose cotransporter type 1 (SGLT1) inhibitor in
development for the treatment of diabetes.
“Results from our Phase 1 studies build on
previously reported promising preclinical data for LX2761 and
confirm the drug candidate’s unique preclinical profile as a
potent, gastrointestinal tract-selective SGLT1 inhibitor,” said
Praveen Tyle, Ph.D., executive vice president of Research and
Development. “We are evaluating next steps for this compound and
look forward to providing updates in the future.”
The Phase 1 clinical studies of LX2761 included
a Phase 1a single ascending-dose study in healthy volunteers and
patients with type 2 diabetes, and a Phase 1b multiple
ascending-dose study in patients with type 2 diabetes.
The Phase 1a study involved 5 cohorts of healthy
volunteers and 2 cohorts of patients with type 2 diabetes. Patients
with type 2 diabetes were washed off metformin for 3 days prior to
dosing. LX2761 demonstrated minimal absorption and no systemic
effect, with no increase in urine glucose excretion from baseline.
In addition, LX2761 reduced postprandial glucose in diabetic
patients while increasing plasma levels of GLP-1. The most common
adverse and dose-limiting event was diarrhea, consistent with the
SGLT1mechanism of action due to reduced glucose absorption in the
gut.
The randomized, double-blind, placebo-controlled
Phase 1b study was performed to assess the safety, tolerability,
pharmacodynamics and pharmacokinetics of multiple doses of orally
administered LX2761 in patients with type 2 diabetes. Patients were
randomly assigned to receive LX2761 or placebo over an 8-day
treatment period as either a single dose or twice a day dose at
breakfast and dinner. Patients were treated with metformin at the
time of screening and for the duration of the study. LX2761 showed
reduced postprandial glucose, demonstrating delayed and reduced
intestinal glucose absorption while increasing plasma levels of
GLP-1 with minimal effect on urinary glucose excretion, consistent
with inhibition of intestinal SGLT1. The most common adverse event
was diarrhea.
About LX2761
LX2761 is an orally-delivered small molecule
compound that is designed to inhibit SGLT1 locally in the
gastrointestinal tract without any significant inhibition of SGLT2
in the kidney. In preclinical studies, LX2761 delayed and reduced
intestinal glucose absorption and reduced postprandial glucose
while increasing plasma levels of GLP-1 with minimal effect on
urinary glucose excretion. Lexicon has granted Sanofi certain
rights of first negotiation with respect to the future development
and commercialization of LX2761.
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 LX2761 and the potential
therapeutic and commercial potential of LX2761. 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 LX2761 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 LX2761 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 LX2761. As a result, LX2761 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, LX9211 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
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