THE WOODLANDS, Texas,
June 9, 2017 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today
announced positive top-line results from its Phase 3 inTandem3
study of sotagliflozin, an investigational dual SGLT1 and SGLT2
inhibitor, for the treatment of patients with type 1 diabetes on
any background insulin therapy. The study met its primary endpoint,
demonstrating the superiority of sotagliflozin 400 mg compared to
placebo in the proportion of patients with A1C <7.0% at Week 24
and no episode of severe hypoglycemia and no episode of diabetic
ketoacidosis (DKA) after randomization.
Sotagliflozin demonstrated a generally well tolerated safety
profile during a 24-week treatment period, with rates of
treatment-emergent adverse events (TEAEs), serious adverse events
(SAEs), and discontinuations due to AEs that were consistent with
rates seen in two prior pivotal Phase 3 studies, inTandem1 and
inTandem2, including a similar rate of severe hypoglycemia for the
sotagliflozin arm compared to placebo during the 24-week treatment
period (2.4% for placebo compared to 3.0% for sotagliflozin 400 mg)
and a slightly higher rate of DKA during the 24-week treatment
period for sotagliflozin 400 mg (3.0%) than placebo (0.6%).
A full analysis of the results from inTandem3, including safety
data, will be submitted for publication in a peer-reviewed
journal.
"The results achieved with sotagliflozin in the inTandem3 study
are scientifically and clinically important and significant," said
Satish Garg, M.D., lead investigator
of inTandem3 and Professor of Medicine and Pediatrics, and Director
Adult Program at the Barbara Davis Center for Diabetes,
University of Colorado Denver and
Editor-in-Chief, Diabetes Technology and Therapeutics. "If
approved, sotagliflozin may potentially be the first option as an
adjunct to insulin to improve glycemic control for patients with
type 1 diabetes."
"These positive results represent an important milestone,
further supporting sotagliflozin's differentiated profile as a
novel, oral anti-diabetic agent with potential to benefit people
with type 1 diabetes," said Lonnel
Coats, Lexicon's president and chief executive officer.
"Sotagliflozin is the first-ever oral anti-diabetic drug candidate
to have achieved success in now three consecutive Phase 3 clinical
trials in this population."
"These compelling results speak to the potential long-term
benefits that sotagliflozin may bring to people with type 1
diabetes," said Jorge Insuasty,
senior vice president, head of global development, Sanofi. "There
are more than 1 million adults with type 1 diabetes in the United States alone, and the majority of
these are not at their A1C goal of 7 percent. The need for diabetes
therapies that help adults with type 1 diabetes control their blood
sugar with fewer complications is clear, and sotagliflozin added to
insulin therapy can potentially help meet that need. We look
forward to pursuing regulatory submissions for the treatment of
type 1 worldwide and to continuing to study the use of
sotagliflozin in adults with type 2 diabetes."
About inTandem3
The Phase 3 study known as inTandem3 was a global, randomized,
double-blind, placebo-controlled, parallel-group, multicenter study
of 1,402 patients with type 1 diabetes on continuous subcutaneous
insulin infusion or multiple daily injection therapy who had an A1C
level entering the study between 7.0% and 11.0%. Patients had a
confirmed diagnosis of type 1 diabetes and inadequate glycemic
control on insulin therapy alone. The study evaluated 400 mg of
sotagliflozin taken once daily before the first meal of the day,
against placebo. The primary objective of the study was to
demonstrate the superiority of sotagliflozin 400 mg versus placebo
in the proportion of patients with glycosylated A1C <7.0% at
Week 24 and no episode of severe hypoglycemia and no episode of DKA
after randomization.
About Sotagliflozin
Discovered using Lexicon's unique approach to gene science,
sotagliflozin is a first-in-class, oral dual inhibitor of two
proteins responsible for glucose regulation known as sodium-glucose
co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is
responsible for glucose absorption in the gastrointestinal tract,
and SGLT2 is responsible for glucose reabsorption by the
kidney.
Lexicon entered into a collaboration and license agreement with
Sanofi in November 2015 under which
Lexicon granted Sanofi an exclusive, worldwide (excluding
Japan), royalty-bearing right and
license to develop, manufacture and commercialize sotagliflozin.
Lexicon is responsible for all clinical development activities
relating to type 1 diabetes and retains an exclusive option to
co-promote and have a significant role, in collaboration with
Sanofi, in the commercialization of sotagliflozin for the treatment
of type 1 diabetes in the U.S. Sanofi is responsible for all
clinical development and commercialization of sotagliflozin for the
treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the
commercialization of sotagliflozin for the treatment of type 1
diabetes outside the U.S. (excluding Japan).
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 recently-launched product for
carcinoid syndrome diarrhea, 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 and its licensees'
clinical development of and regulatory filings for sotagliflozin
and the results and projected timing of clinical trials and the
potential therapeutic and commercial potential of sotagliflozin. 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 the risk that clinical studies of
sotagliflozin 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 sotagliflozin 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 sotagliflozin.
As a result, sotagliflozin may never be successfully
commercialized. Other risks include Lexicon's ability to meet its
capital requirements, successfully conduct preclinical and clinical
development and obtain necessary regulatory approvals of its other
potential drug candidates, 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, 2016, 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.
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SOURCE Lexicon Pharmaceuticals, Inc.