Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), received preliminary
topline results from Sanofi for three Phase 3 trials of
Zynquista™ (sotagliflozin) in adults living with type 2
diabetes from the InSynchrony clinical program. Lexicon has not yet
received the underlying data, and expects to conduct its own review
and validation and statistical analysis of the data when they are
received.
The preliminary topline results received from
Sanofi for the three studies are as follows:
- In SOTA-MET, Zynquista 400 mg demonstrated a statistically
significant reduction in blood sugar control (A1C) compared to
placebo at 26 weeks in patients on metformin.
- In SOTA-CKD3, Zynquista 400 mg showed a statistically
significant reduction in A1C in the entire population of patients
with moderate (stage 3) chronic kidney disease (CKD) and in the
subpopulation of patients with a glomerular filtration rate of
45-<60 mL/min/1.73m2 (stage 3A CKD) compared to placebo at 26
weeks. Although Zynquista demonstrated numerical improvement on
A1C, a statistically significant reduction in A1C was not achieved
in the subpopulation of patients with a glomerular filtration rate
of 30-<45 mL/min/1.73m2 (stage 3B CKD).
- In SOTA-CKD4, Zynquista 400 mg achieved a clinically meaningful
effect but narrowly missed statistical significance on A1C
reduction versus placebo in patients with severe (stage 4) CKD at
26 weeks.
Zynquista was well tolerated in all three
studies.
The data from these studies is planned to be
presented at upcoming medical conferences.
“We are pleased that today’s results support the
potential benefits Zynquista may bring to adults living with type 2
diabetes, particularly for those living with chronic kidney
disease,” said Pablo Lapuerta, M.D., executive vice president and
chief medical officer at Lexicon. “Although the SOTA-CKD4 study
appears to have narrowly missed statistical significance on A1C, we
are very encouraged by the overall results in that study and look
forward to Phase 3 data from the remainder of the core studies from
the InSynchrony program later this year.”
Separately, 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. The collaboration and license agreement
provides that, even if a valid termination of the alliance had been
delivered, Sanofi has continuing contractual obligations to
transition rights to sotagliflozin and continue to fund ongoing
clinical trials for a contractually specified period of time
following termination.
“While we are disappointed in the position taken
by Sanofi, we are confident in the strength of the data we have
seen thus far in the type 2 diabetes program and are optimistic
about achieving continued success in the balance of the core Phase
3 program, which we expect will be completed in the coming months,”
said Lonnel Coats, Lexicon’s president and chief executive officer.
“In the event of a valid termination of the Sanofi alliance, we
will also look forward to regaining full rights to Zynquista in
type 1 diabetes in the United States, as well as rights in the
remainder of the world, notably including the European Union, in
which Zynquista has already received approval.”
Lexicon will be hosting a live conference call
and webcast on Thursday, August 1, 2019 at 8:00 am EDT / 7:00 am
CDT to review its financial and operating results and to provide a
general business update. 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 5789855. 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 the InSynchrony Type 2 Diabetes
Phase 3 Clinical Trial Program
The InSynchrony program consists of 11 Phase 3
clinical trials to evaluate the efficacy and safety of Zynquista in
adults with type 2 diabetes on various therapeutic backgrounds
(i.e., diet and exercise alone, metformin, a sulfonylurea, a
dipeptidyl peptidase 4 inhibitor, or basal insulin). These trials
include placebo and active comparators (i.e., glimepiride and
empagliflozin) and also is evaluating patients with CKD,
cardiovascular risk factors, and heart failure, as well as patients
age 55 and older.
SOTA-MET, SOTA-CKD3 and SOTA-CKD4 are the first
trials to report data from the program:
SOTA-MET is evaluating the efficacy and safety
of Zynquista (400 mg once daily) in adults with type 2 diabetes
with inadequate blood sugar control on metformin, compared to
placebo.
SOTA-CKD3 and SOTA-CKD4 are evaluating the
efficacy and safety of two doses of Zynquista (200 mg and 400 mg
once daily) in adults with type 2 diabetes and moderate to severe
CKD with inadequate blood sugar control receiving standard of care
treatment, compared to 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.
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® (telotristat ethyl), 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 sotagliflozin. 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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