THE WOODLANDS, Texas,
Dec. 21, 2016 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced
today that its pivotal inTandem2 Phase 3 clinical trial of
sotagliflozin met its primary endpoint, showing a statistically
significant reduction in A1C at 24 weeks in patients with type 1
diabetes on optimized insulin therapy.
Top-line results from the Phase 3 study showed that patients
treated with sotagliflozin had mean A1C reductions from baseline of
0.39% on 200mg once daily sotagliflozin dose (p<0.001) and 0.37%
on 400mg once daily sotagliflozin dose (p<0.001) as compared to
a reduction of 0.03% on placebo after 24 weeks of treatment,
meeting the study's primary endpoint. This statistically
significant and clinically meaningful improvement in A1C for both
doses of sotagliflozin was achieved with a favorable overall safety
profile in the study, including rates of severe hypoglycemia
similar to placebo and low overall rates of diabetic ketoacidosis
(DKA).
"These top-line results confirm the results we announced earlier
this year from our first pivotal Phase 3 study of sotagliflozin,"
said Lexicon president and chief executive officer, Lonnel Coats. "We are extremely pleased
with the results in both of these Phase 3 studies and are
enthusiastic about the potential benefits that sotagliflozin may
bring to people with type 1 diabetes."
"The inTandem2 study demonstrated a compelling safety and
efficacy profile for sotagliflozin in adults living with type 1
diabetes," said Thomas Danne, M.D.,
Head of the Center for Children Endocrinology and Diabetes at the
Children's Hospital on the Bult in Hannover, Germany and primary investigator for
the inTandem2 clinical trial. "The potential to significantly
lower A1C levels without an increase in hypoglycemia would
represent a major shift in the treatment paradigm for type 1
diabetes."
About inTandem2
The double-blind, placebo controlled, Phase 3 study known as
inTandem2 randomized 782 adult patients in Europe and Israel with type 1 diabetes on insulin pump or
multiple daily injection therapy who had an A1C level entering the
study between 7.0% and 11.0%. The three-arm study evaluated
two doses of sotagliflozin, 200mg and 400mg, each taken once daily
before the first meal of the day, against placebo. Prior to
randomization, insulin was optimized for all patients over a
six-week period, with the objective of improving glycemic control
using insulin alone. After completion of this optimization
period, patients were maintained on optimized insulin and
randomized to one of two doses of sotagliflozin or placebo, and
their baseline, post-optimization A1C was measured. The mean
baseline A1C levels after the six-week optimization period were
7.80%, 7.74% and 7.71% for patients randomized to the placebo,
200mg and 400mg arms, respectively.
The primary endpoint of the study was change in A1C from
baseline after a 24-week period of treatment. The trial has a
double-blind long term extension of 28 weeks, with a total
treatment duration of 52 weeks. There were 257 patients in
the placebo arm, 261 patients in the 200mg dose arm and 263
patients in the 400mg dose arm. The overall mean
placebo-adjusted A1C reduction at week 24 was 0.36% in the 200mg
dose arm (p<0.001) and 0.35% in the 400mg dose arm
(p<0.001).
Sotagliflozin was generally well tolerated. Across
all three dose arms (placebo, 200mg, 400mg), the incidences of
treatment-emergent adverse events (AEs) were 51.4%, 55.9% and
54.4%, respectively; the incidences of serious AEs (SAEs) were
3.5%, 4.2% and 4.2%, respectively; and discontinuations due to AEs
were 1.6%, 1.9% and 3.0%, respectively. There were two deaths
in the study in the placebo arm and no deaths in either
sotagliflozin arm.
Two primary safety concerns for patients with type 1 diabetes
are severe hypoglycemia and diabetic ketoacidosis (DKA). The
number of patients with severe hypoglycemic events during the
24-week treatment period was seven (2.7%), ten (3.8%), and six
(2.3%) in the placebo, 200mg and 400mg dose arms,
respectively. The number of patients with DKA events during
the 24-week treatment period was none (0.0%), one (0.4%), and three
(1.1%) in the placebo, 200mg and 400mg dose arms,
respectively.
Lexicon is conducting a third Phase 3 clinical trial in type 1
diabetes patients, inTandem3, which is studying approximately 1,400
patients treated with sotagliflozin 400mg once daily or placebo on
a background of any insulin therapy, but without insulin
optimization prior to randomization. Sanofi is responsible for
conducting the Phase 3 clinical trials for sotagliflozin in
patients with type 2 diabetes.
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 the
primary transporter for absorption of glucose and galactose in the
gastrointestinal tract, and SGLT2 is primarily responsible for
glucose reabsorption by the kidney. Sotagliflozin has been
shown in a Phase 2 study to improve glycemic control in people with
type 1 diabetes while reducing their need for mealtime
insulin.
Lexicon entered into a collaboration and license agreement with
Sanofi in November 2015 under which
Lexicon granted Sanofi an exclusive, 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 United
States. Sanofi is responsible for all clinical development
and commercialization of sotagliflozin for the treatment of type 2
diabetes in the licensed territory and is solely responsible for
the commercialization of sotagliflozin for the treatment of type 1
diabetes outside the United
States.
Lexicon Conference Call
Lexicon management will hold a conference call and webcast to
discuss the inTandem2 Phase 3 top-line results at 8:30 a.m. Eastern Time on December 21, 2016. The dial-in number for
the conference call is 888-645-5785 (within the US/Canada) or 970-300-1531 (international).
The conference ID for all callers is 43517998. Investors can
access a live webcast of the call at www.lexpharma.com. An
archived version of the webcast will be available on the website
through January 21, 2017.
About Lexicon
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. Lexicon has a pipeline of promising drug candidates
in clinical and pre-clinical development in oncology, diabetes and
metabolism. 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
(LX4211) 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, 2015, 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.