THE WOODLANDS, Texas,
June 10, 2017 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced data from its
two pivotal sotagliflozin studies, inTandem1 and inTandem2, being
presented at the 77th American Diabetes Association
(ADA) Scientific Sessions in San Diego,
CA.
Collectively, 24-week data from the two pivotal inTandem1 and
inTandem2 studies for sotagliflozin in patients with type 1
diabetes demonstrated the following:
- Sotagliflozin 200 mg and 400 mg on top of optimized insulin
significantly reduced A1C compared to placebo (p<0.001 in both
studies).
- Sotagliflozin was generally well tolerated. In both studies,
there was a low rate of severe hypoglycemia, which occurred less
frequently on sotagliflozin than placebo in three of four arms
across the two studies. In both studies, there was a low
diabetic ketoacidosis (DKA) rate (0.4% to 3.1% over 24 weeks) that
was higher for patients on insulin pump versus multiple dose
injections (MDI).
inTandem1 Study – "Twenty-Four Week Efficacy and Safety of
Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy
to Insulin in Type 1 Diabetes" (#69-OR)
- inTandem1 met its primary endpoint of change in A1C from
baseline after a 24-week treatment period. The percentage reduction
in A1C from baseline after 24 weeks of treatment were 0.08%, 0.43%
and 0.49% for placebo, 200 mg, and 400 mg, respectively. The
difference compared to placebo for patients treated with
sotagliflozin 200 mg and 400 mg once daily were 0.36% and 0.41%,
respectively (p<0.001 for both doses).
- All secondary endpoints, including net benefit (A1C <7.0%
with no episode of severe hypoglycemia and no episode of DKA),
weight, bolus insulin, fasting plasma glucose (FPG) and two
patient-reported outcomes, were statistical significant in the 400
mg arm. Net benefit and weight were statistical significant in the
200 mg arm as well.
- Sotagliflozin was generally well tolerated. Across all three
dose arms, the incidence of treatment-emergent adverse events
(TEAEs) over 24 weeks of treatment was 67.5%, 67.3% and 71.0% on
placebo, 200 mg and 400 mg, respectively. The incidence of serious
adverse events (SAEs) was 3.4%, 3.8% and 6.9% on placebo, 200 mg
and 400 mg, respectively. Discontinuations due to AEs were 1.5%,
1.1% and 3.8% on placebo, 200 mg and 400 mg, respectively. There
were no deaths reported in the study.
- There was no increase in severe hypoglycemic events during the
24-week treatment period (18 (6.7%), 11 (4.2%) and 12 (4.6%) in the
placebo, 200 mg and 400 mg dose arms, respectively). There was a
0.4% rate of discontinuation due to severe hypoglycemia in the
placebo arm and no discontinuations in the 200 mg and 400 mg drug
arms.
- The number of patients with severe hypoglycemic events on
insulin pump was 7 (4.4%), 7 (4.5%) and 10 (6.4%) in the placebo,
200 mg and 400 mg dose arms, respectively. The number of patients
with severe hypoglycemic events on MDI was 11 (10.2%), 4 (3.7%) and
2 (1.9%) in the placebo, 200 mg and 400 mg dose arms,
respectively.
- The number of patients positively adjudicated with DKA events
during the 24-week treatment period was 0 (0.0%), 3 (1.1%) and 8
(3.1%) in the placebo, 200 mg and 400 mg dose arms, respectively,
with a discontinuation rate due to DKA events of 0.0%, 0.4% and
0.8%, respectively.
- The number of positively adjudicated DKA events through Week 24
were more common with patients on pump compared to patients using
MDI (pump: 0 patients (0.0%) for placebo, compared to 2 (1.3%) and
6 (3.8%) for 200 mg and 400 mg, respectively; MDI: 0 (0.0%) for
placebo, compared to 1 (0.9%) and 2 (1.9%) for 200 mg and 400 mg,
respectively). The majority of DKA cases in the 400 mg arm had
blood glucose levels of <250 mg/dL.
inTandem2 Study – "Twenty- Four–Week Efficacy and Safety of
Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy
to Insulin in Type 1 Diabetes" (poster #146-LB)
- The percentage reduction in A1C from baseline after 24 weeks of
treatment were 0.03%, 0.39% and 0.37% for placebo, 200 mg and 400
mg, respectively (p=0.54, p<0.001 and p<0.001, respectively).
The difference compared to placebo for patients treated with
sotagliflozin 200 mg and 400 mg once daily were 0.36% and 0.35%,
respectively (p<0.001 for both doses).
- Sotagliflozin 200 mg and 400 mg compared to placebo achieved
statistical significance (p<0.001) on the net benefit endpoint
(AIC <7.0% with no episode of severe hypoglycemia and no episode
of DKA).
- Sotagliflozin was generally well tolerated. Across all three
dose arms, the incidence of treatment-emergent adverse events
(TEAEs) over 24 weeks of treatment was 51.4%, 55.9% and 54.4% on
placebo, 200 mg and 400 mg, respectively. The incidence of serious
adverse events (SAEs) was 3.5% on placebo and 4.2% on both 200 mg
and 400 mg. Discontinuations due to AEs were 1.6%, 1.9% and 3.0% on
placebo, 200 mg and 400 mg, respectively. There were two deaths
reported in the placebo arm and no deaths in the 200mg and 400 mg
arms.
- There was no dose-related increase in the rate of severe
hypoglycemia during the 24-week treatment period (7 (2.7%), 10
(3.8%) and 6 (2.3%) in the placebo, 200 mg and 400 mg dose arms,
respectively). There were no discontinuations due to severe
hypoglycemia in any of the study arms.
- The number of patients with severe hypoglycemic events on
insulin pump was 2 (3.0%), 4 (5.9%) and 3 (4.5%) in the placebo,
200 mg and 400 mg dose arms, respectively. The number of patients
with severe hypoglycemic events on MDI was 5 (2.6%), 6 (3.1%) and 3
(1.5%) in the placebo, 200 mg and 400 mg dose arms,
respectively.
- The number of patients positively adjudicated with DKA events
during the 24-week treatment period was 0 (0.0%), 1 (0.4%) and 3
(1.1%) in the placebo, 200 mg and 400 mg dose arms, respectively,
with a discontinuation rate due to DKA events of 0.0%, 0.0% and
0.8%, respectively.
- The number of positively adjudicated DKA events through Week 24
were more common with patients on pump compared to patients using
MDI or placebo (pump: 0 patients (0.0%) for placebo, compared to 0
(0.0%) and 3 (4.5%) for 200 mg and 400 mg, respectively; MDI: 0
(0.0%) for placebo, compared to 1 (0.5%) and 0 (0.0%) for 200 mg
and 400 mg, respectively).
"There remains a need for oral therapeutic agents in addition to
insulin to help improve quality of life in patients with type 1
diabetes by reducing the diabetes management burden and
sotagliflozin has that potential," said John Buse, M.D., Ph.D., lead investigator of
inTandem1 and Professor of Medicine, Chief of the Division of
Endocrinology and Metabolism, Director of the Diabetes Care Center,
and Executive Associate Dean for Clinical Research at the
University of North Carolina School of
Medicine. "Sotagliflozin has demonstrated, in three Phase 3
studies, the ability for patients to achieve glycemic goals with a
safety profile that supports its utility in the type 1 diabetes
community."
"We are extremely pleased with the results achieved by
sotagliflozin in its three Phase 3 studies," said Lonnel Coats, Lexicon's president and chief
executive officer. "We look forward to seeing the pooled continuous
glucose monitoring data from inTandem1 and inTandem2 as well as
data from secondary endpoints in inTandem2 in the third
quarter."
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.