THE WOODLANDS,
Texas, Sept. 13, 2017
/PRNewswire/ -- Lexicon Pharmaceuticals, Inc.
(Nasdaq: LXRX) today announced that the New England
Journal of Medicine (NEJM) published the results of the 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 data were published online
today in conjunction with presentation of these data at the
European Association for the Study of Diabetes (EASD)
53rd annual meeting (September
11-15, Lisbon, Portugal) in
a session titled, "The Phase 3 inTandem clinical program:
efficacy and safety of sotagliflozin in adults with type 1
diabetes."
The study met its primary endpoint with statistical
significance, 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
DKA after randomization. The responder rate for patients on
sotagliflozin was approximately twice the rate as compared to
placebo. The difference compared to placebo for patients treated
with sotagliflozin was 13.4% (p<0.001).
"The clinically meaningful and statistically significant
effects of sotagliflozin on glucose control (A1C) were achieved
with a similar rate of severe hypoglycemia while reducing weight
and blood pressure in hypertensive patients with type 1 diabetes.
The combination of these effects provides a differentiated drug
profile and the opportunity for sotagliflozin to transform the
treatment paradigm as a novel oral adjunct to insulin therapy in
this patient population," said Satish
Garg, M.D., lead investigator of inTandem3, 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. "Managing type 1 diabetes can be very challenging for
patients and their caregivers and as a clinician treating patients
with this condition, these positive results bring promise for our
ability to improve lives."
The outcome on every secondary endpoint achieved
statistical significance favoring sotagliflozin over placebo,
including change from baseline in A1C, body weight, systolic blood
pressure (SBP) in patients with baseline SBP ≥130 mm Hg and bolus
insulin.
Sotagliflozin significantly reduced A1C compared to
placebo after 24 weeks of treatment. The least squares (LS) mean
reduction in A1C from baseline was 0.79% and 0.33% for
sotagliflozin and placebo, respectively. The difference compared to
placebo for patients treated with sotagliflozin was 0.46%
(p<0.001).
Patients taking sotagliflozin experienced an LS mean
reduction from baseline in body weight after 24 weeks of treatment
of 2.2 kg compared to a mean body weight gain of 0.8 kg for
patients on placebo (p<0.001 for sotagliflozin and placebo). The
reduction in LS means compared to placebo for patients treated with
sotagliflozin was 3.0 kg (p<0.001).
Systolic blood pressure in the subset of type 1 diabetic
patients in the study with baseline hypertension (SBP ≥130 mm Hg)
was reduced by 9.2 mm Hg at Week 16 when treated with sotagliflozin
compared to a reduction of 5.7 mm Hg on placebo (p<0.001 for
sotagliflozin and placebo). The reduction in LS means compared to
placebo for patients treated with sotagliflozin was 3.5 mm Hg
(p=0.002).
Sotagliflozin significantly reduced the amount of bolus
insulin used compared to placebo after 24 weeks of treatment. The
reduction in bolus insulin from baseline was 3.9 IU per day and 1.1
IU per day for sotagliflozin and placebo, respectively (p<0.001
and p=0.02, respectively). The reduction in LS means compared to
placebo for patients treated with sotagliflozin was 2.8 IU per day
(p<0.001).
Sotagliflozin demonstrated a generally well tolerated
safety profile during a 24-week treatment period, with rates of
treatment-emergent adverse events, serious adverse events, and
discontinuations due to adverse events 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 (3.0% for sotagliflozin compared to
2.4% for placebo). There was a higher rate of DKA during the
24-week treatment period for sotagliflozin (3.0%) than placebo
(0.6%). Other adverse events of special interest included diarrhea
(sotagliflozin 4.1%, placebo 2.3%) and genital mycotic infection
(sotagliflozin 6.4%, placebo 2.1%).
"We are extremely proud to have the inTandem3 results
published in such a prestigious journal, which will raise
much-needed awareness of type 1 diabetes in the medical community,"
said Lonnel Coats, Lexicon's
president and chief executive officer. "Collectively, today's
positive findings as well as data from our two pivotal trials
underline the importance and relevance of the dual SGLT1 and SGLT2
inhibitor mechanism of action in diabetes. As we remain committed
to advancing the science in diabetes and bringing innovative
therapies to patients to help improve outcomes and ease the burden
of managing their diabetes, we look forward to Sanofi's filing for
global regulatory approval for type 1 diabetes in the first half of
2018."
"Despite treatment with insulin analogues, approximately
70% of patients with type 1 diabetes do not reach the desired
glycemic A1C target of <7.0%," said Juliana Oliveira, Vice President and Global
Project Head for Sotagliflozin, Sanofi. "These outcomes further
highlight the large unmet need for new oral medications that can be
added to insulin, and publication of these results in the New
England Journal of Medicine will increase awareness of this
need."
Conference Call and Webcast Information
Lexicon management will hold a live conference call and
webcast today at 8:00 am EDT /
7:00 am CDT to provide an update on
the sotagliflozin program from EASD. The dial-in number for the
conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The
conference ID for all callers is 84533796. The live webcast and
replay may be accessed by visiting Lexicon's website at
www.lexpharma.com/investors. An archived version of the webcast
will be available on the website for 14 days.
About inTandem3
The Phase 3 study known as inTandem3 was a global,
randomized, double-blind, placebo-controlled, parallel-group,
multicenter study of 1,405 patients with type 1 diabetes on any
background insulin 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 versus placebo
taken once daily before the first meal of the day. 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. Secondary
endpoints included change from baseline in A1C, body weight,
systolic blood pressure (SBP) in patients with baseline SBP ≥130 mm
Hg and bolus insulin.
About Sotagliflozin
Discovered using Lexicon's unique approach to gene
science, sotagliflozin is an investigational 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 has exercised 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 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 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.