Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today presented
six posters for ZynquistaTM (sotagliflozin) at the virtual 80th
American Diabetes Association (ADA) Scientific Sessions including
additional efficacy and safety data patients with type 2 diabetes
and moderate and severe renal impairment.
Phase 3 CKD-3 Study
In the Phase 3, multicenter, randomized,
double-blind, placebo-controlled CKD-3 study, sotagliflozin was
tested for superiority versus placebo in reducing A1C after 26
weeks of treatment in patients with type 2 diabetes, inadequate
glycemic control and moderate (CKD Stage 3) renal impairment.
The study met its primary endpoint,
demonstrating that sotagliflozin 400 mg significantly reduced A1C
in the entire population of patients with moderate renal impairment
compared to placebo at Week 26. The difference in least squares
(LS) mean change in A1C from baseline for patients treated with
sotagliflozin 400 mg compared to placebo was -0.24% (p = 0.0021).
The change in A1C from baseline was not statistically different in
patients treated with sotagliflozin 200 mg compared to placebo (p =
0.2085).
The safety profile of sotagliflozin was
generally similar to that of placebo. Incidences of symptomatic
hypoglycemia (with documented blood glucose ≤70 mg/dL) were 20.4%
on sotagliflozin 400 mg, 27.3% on sotagliflozin 200 mg, and 25.0%
on placebo. The rates of symptomatic hypoglycemia (per 100 patient
years of exposure) were 114.0 on sotagliflozin 400 mg, 140.5 on
sotagliflozin 200 mg, and 175.4 on placebo.
Phase 3 CKD-4 Study
In the Phase 3, multicenter, randomized,
double-blind, placebo-controlled CKD-4 study, sotagliflozin was
tested for superiority versus placebo in reducing A1C after 26
weeks of treatment in patients with type 2 diabetes, inadequate
glycemic control and severe (CKD Stage 4) renal impairment.
The study did not meet its primary endpoint of
demonstrating superiority of sotagliflozin versus placebo on A1C
reduction after 26 weeks of treatment in patients with type 2
diabetes, inadequate glycemic control and severe renal impairment
compared to placebo. The placebo-adjusted difference in A1C from
baseline for patients treated with sotagliflozin 400 mg compared to
placebo was -0.29% (p = 0.0962) at week 26. For sotagliflozin 200
mg, the placebo-adjusted difference in A1C was 0.05% (p =
0.8124).
Several findings indicated clinically meaningful
glycemic control over time was achieved with sotagliflozin 400 mg.
From baseline to Week 52, the placebo-subtracted A1C reduction for
sotagliflozin 400 mg was -0.69% (95% confidence interval: -0.23,
-1.15). At Week 52, achievement of A1C ≤ 7% was seen in 20.7% of
patients on sotagliflozin 400 mg compared to 6.5% on placebo. Over
52 weeks, the incidence of rescue therapy to treat hyperglycemia
was 7.6% on sotagliflozin 400 mg and 15.1% on placebo. Results were
consistent with a dose related-response, as the 200 mg dose group
at Week 52 had a placebo-subtracted A1C reduction of -0.32%, 19.6%
of patients achieved A1C ≤ 7%, and 10.9% required rescue
therapy.
The safety profile of sotagliflozin was
generally similar to that of placebo. This was a population at high
cardiovascular risk, and the incidences of major adverse
cardiovascular events (myocardial infarction, stroke, and
cardiovascular death) were 4.4% on sotagliflozin 400 mg, 1.1% on
sotagliflozin 200 mg, and 11.9% on placebo. Incidences of
symptomatic hypoglycemia (with documented blood glucose ≤70 mg/dL)
were 27.8% on sotagliflozin 400 mg, 28.7% on sotagliflozin 200 mg
and 35.5% on placebo, and the rates (per 100 patient years of
exposure) were 171.6 on sotagliflozin 400 mg, 226.9 on
sotagliflozin 200 mg, and 269.8 on placebo.
Additional poster
presentations
- Effects of sotagliflozin added to insulin therapy on
beta-hydroxybutyrate in patients with type 1 diabetes. Peters, D.
et al.
- Efficacy and safety of sotagliflozin by baseline renal function
in adults with type 1 diabetes. Handelsman, Y. et al.
- Balancing the risk of DKA and severe hypoglycemia with
sotagliflozin in adults with type 1 diabetes. Pettus, J. et
al.
- Impact of treatment with sotagliflozin on the incidence of
severe hypoglycemia in patients with T1D. Pettus, J.
About Sotagliflozin
Discovered using Lexicon’s unique approach to
gene science, sotagliflozin is an 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.
Sotagliflozin is approved in the European Union (EU) for use as an
adjunct to insulin therapy to improve blood sugar (glycemic)
control in adults with type 1 diabetes with a body mass index ≥ 27
kg/m2, who could not achieve adequate glycemic control despite
optimal insulin therapy.
About Lexicon
Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical
company with a mission of pioneering medicines that transform
patients’ lives. Through its Genome5000™ program, Lexicon
scientists studied the role and function of nearly 5,000 genes and
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, Lexicon has a pipeline of promising drug candidates in
clinical and preclinical development in diabetes and metabolism,
oncology 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 long-term
outlook on its business, including the clinical development of, the
regulatory filings for, and the potential therapeutic and
commercial potential of XERMELO (telotristat ethyl), Zynquista
(sotagliflozin), and LX9211. 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 Lexicon’s ability to meet its capital requirements,
successfully commercialize XERMELO, successfully conduct
preclinical and clinical development and obtain necessary
regulatory approvals of telotristat ethyl, sotagliflozin, LX9211
and 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, 2019, 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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