Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced
positive 52-week cardiorenal results from a pooled analysis from
the inTandem1 and inTandem2 studies of
Zynquista™ (sotagliflozin) in adults with type 1 diabetes.
Zynquista demonstrated changes in clinical biomarkers such as
estimated glomerular filtration rate (eGFR), hematocrit, serum
albumin, uric acid, systolic blood pressure and urinary
albumin-to-creatinine ratio (UACR) that suggest Zynquista may
reduce cardiovascular risk and progression of chronic kidney
disease. Zynquista was associated with short- and long-term renal
hemodynamic changes. Importantly, after cessation of 52 weeks of
therapy, eGFR was comparable to baseline and significantly higher
than placebo in Zynquista-treated patients.
These results were recently published in
Diabetes Care, the ADA’s peer-reviewed research journal dedicated
to diabetes treatment and prevention. The online publication, “The
Impact of Sotagliflozin on Renal Function, Albuminuria, Blood
Pressure, and Hematocrit in Adults with Type 1 Diabetes”, may be
accessed here https://doi.org/10.2337/dc19-0937.
New 52-week findings from a pooled analysis from
inTandem1, a 793-patient, double-blind, placebo-controlled Phase 3
study, and inTandem2, a 782-patient double-blind,
placebo-controlled Phase 3 study demonstrated that Zynquista 200 mg
and 400 mg, in combination with insulin, were associated with
short- and long-term renal hemodynamic changes. Generally
consistent with what has been seen with selective SGLT2 inhibitors
in type 2 diabetes, study participants randomized to Zynquista
experienced a modest initial reduction in eGFR that quickly
stabilized. In the pooled analysis, the placebo-corrected least
squares mean change from baseline in eGFR was −2.0 mL/min/1.73 m2
(p = 0.010) and −0.5 mL/min/1.73 m2 (p = 0.52) for the 200 mg and
400 mg doses, respectively. Importantly, in the subset of patients
(n = 370) with off drug follow-up laboratory records, defined as 7
days after last dose, eGFR returned to baseline for study
participants randomized to Zynquista, but not to placebo, with a
placebo-corrected LS mean change from baseline to off drug records
of +3.0 mL/min/1.73 m2 (p = 0.031) and +2.7 mL/min/1.73 m2 (p =
0.045) for Zynquista 200 mg and 400 mg, respectively.
Zynquista demonstrated meaningful effects on
markers of hemoconcentration and plasma uric acid, where
biochemical changes have been linked to cardiorenal protection
associated with SGLT2 inhibitors. Mean serum hematocrit increased
from 41.9% at baseline to 43.8% at Week 12 for Zynquista 200 mg and
from 42.0% to 44.0% for Zynquista 400 mg. Relative to placebo, the
LS mean difference was 1.8% and 1.9% for Zynquista 200 mg and 400
mg, respectively (p < 0.0001, for both). These changes persisted
throughout the 52-week trial at both Zynquista doses (p <
0.0001). Mean baseline serum albumin concentrations were similar,
at approximately 4.3 g/dL for all groups. LS mean serum albumin
increased 0.06 g/dL and 0.07 g/dL with Zynquista 200 mg and 400 mg,
respectively, at Week 4 (p < 0.0001, for both). At Week 52,
placebo-corrected LS mean change was 0.03 g/dL (p = 0.036) for
Zynquista 200 mg and 0.03 g/dL (p = 0.053) for Zynquista 400 mg.
Zynquista also significantly reduced uric acid throughout 52 weeks
(p < 0.001). The placebo-corrected LS mean change in serum uric
acid was 20.29 mg/dL and 20.42 mg/dL (p < 0.0001 for both) at 4
weeks and 20.17 mg/dL (p = 0.0003) and 20.28 mg/dL (p < 0.0001)
at 52 weeks for Zynquista 200 mg and 400 mg, respectively.
Zynquista demonstrated consistent lowering of
blood pressure and urinary albumin-to-creatinine ratio (UACR).
Systolic blood pressure difference was −2.9 and −3.6 mmHg (p <
0.0001 for both doses) for Zynquista 200 mg and Zynquista 400 mg,
respectively, placebo-adjusted. Diastolic blood pressure changed by
−1.4 (p = 0.0033) and −1.6 mmHg (p = 0.0008) placebo-adjusted. Of
note, in patients whose current blood pressure targets were above
and below 130/80 mmHg, the impact of Zynquista was comparable and
resulted in clinically relevant blood pressure lowering. As for
UACR, in patients with baseline UACR ≥30 mg/g, UACR decreased by
23.7% (p = 0.054) and 18.3% (p = 0.18) for Zynquista 200 mg and 400
mg, respectively, versus placebo.
About Zynquista
(sotagliflozin)
Discovered using Lexicon’s unique approach to
gene science, Zynquista 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.
Zynquista 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. Outside of such approval, Zynquista is
investigational and has not been approved by any other regulatory
authority for type 1 or type 2 diabetes.
Lexicon has granted Sanofi an exclusive
worldwide (excluding Japan) license to develop, manufacture and
commercialize Zynquista. Lexicon remains responsible for all
clinical development activities relating to type 1 diabetes and
Sanofi is responsible for all clinical development activities of
Zynquista for the treatment of type 2 diabetes. Sanofi has
delivered to Lexicon a notice purporting to terminate the alliance.
Lexicon has notified Sanofi that it considers the notice invalid
and Sanofi to be in breach of contract.
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 status of its alliance with
Sanofi, the commercialization of XERMELO (telotristat ethyl) and
Zynquista (sotagliflozin), and the clinical development of, the
regulatory filings for, and the potential therapeutic and
commercial potential of telotristat ethyl, sotagliflozin, LX2761
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, LX2761, 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, 2018, 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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