THE WOODLANDS, Texas,
April 14, 2014 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced
today positive, top-line results in a Phase 2 clinical trial of
LX4211 in type 1 diabetes, which achieved the primary endpoint of
reducing mealtime insulin use as well as several secondary
endpoints, including improved glycemic control. LX4211 is an
oral, first-in-class, dual inhibitor of sodium glucose transporters
1 and 2 (SGLT1 and SGLT2) that is designed to lower blood glucose
levels through two insulin-independent mechanisms of action.
In the placebo-controlled, double-blind, 28-day study, LX4211
reduced the total daily mealtime bolus insulin dose by 32% compared
to 6% for placebo (p=0.007), while significantly improving glycemic
control with a mean HbA1c reduction of 0.55% in the LX4211-treated
group compared to a reduction of only 0.06% with placebo (p=0.002).
This improvement was accompanied by significant improvement
in the time spent in a glucose range of 70-180 mg/dl, a significant
reduction in time in hyperglycemic range, and no increase in
hypoglycemia. Multiple measures indicated that LX4211
treatment resulted in reduced variability in blood glucose levels.
Overall, LX4211 was well tolerated with no discontinuations
of study medication due to adverse events.
"The results from this study provide a clear demonstration of
proof-of-concept of LX4211 as an oral, investigational new drug for
type 1 diabetes complementing insulin therapy," said Arthur Sands, M.D., Ph.D., Lexicon's president
and chief executive officer. "The magnitude of improved
glycemic control by several measures, including HbA1c in only four
weeks, and lower insulin requirements are highly encouraging and
support the progression of LX4211 into late-stage development for
type 1 diabetes."
In this multicenter study, 33 patients with poorly controlled
type 1 diabetes on either an insulin pump or multiple insulin
injection therapy were randomized 1:1 to receive either placebo or
a 400 mg dose of LX4211 orally once per day before breakfast for
four weeks. Patients adjusted their insulin as needed, recorded
their blood sugars, and then were evaluated at the end of the study
for amount of insulin used and glycemic control, as measured by
HbA1c, continuous glucose monitors and serum blood glucose
measures. Lexicon plans to present full results of the study at a
scientific congress.
"An oral agent benefiting patients with type 1 diabetes through
both substantial improvements in glucose control and significant
reduction in the use of insulin with no increase in hypoglycemia is
both new and clinically meaningful," said Pablo Lapuerta, M.D., Lexicon's chief medical
officer. "These results provide a strong rationale for
demonstrating the effectiveness of LX4211 as an adjunct to insulin
in Type 1 diabetes in a longer-term Phase 3 program."
Type 1 diabetes is a serious condition affecting more than one
million people in the United
States, both children and adults. Type 1 diabetes is an
autoimmune disease in which a person's pancreas stops producing
insulin, a hormone that enables people to get energy from food. It
occurs when the body's immune system attacks and destroys the
insulin-producing cells in the pancreas. Insulin is a required
treatment, with few additional treatment options. The
effectiveness of insulin is limited by concerns about potentially
serious hypoglycemia; therefore, most patients with type 1 diabetes
do not achieve their targets for glucose control. In addition,
insulin therapy does not necessarily prevent the possibility of the
disease's serious complications, which may include kidney failure,
blindness, nerve damage, heart attack and stroke. As an oral agent,
LX4211 is designed to delay the absorption of glucose in the
gastrointestinal tract and enhance glucose excretion in the kidney,
allowing glucose control to improve and insulin doses to be
reduced.
Lexicon Conference Call
Lexicon management will hold a conference call and webcast to
discuss the LX4211 Phase 2 top-line data at 8:30 a.m. Eastern Time on April 14, 2014.
The dial-in number for the conference call is 888-645-5785
(within the US/Canada) or
970-300-1531 (international). The conference ID for all
callers is 30215299. Investors can access a live webcast of
the call at www.lexpharma.com. An archived version of the
webcast will be available on Lexicon's corporate website through
May 14, 2014.
About Lexicon
Lexicon is a biopharmaceutical company focused on developing
breakthrough treatments for human disease. Lexicon has
clinical-stage drug programs for diabetes, carcinoid syndrome, and
other indications, all of which were discovered by Lexicon's
research team. Lexicon has used its proprietary gene knockout
technology to identify more than 100 promising drug targets.
For additional information about Lexicon and its programs, please
visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's clinical development of
LX4211, characterizations of the results of and projected timing of
clinical trials of LX4211, and the potential therapeutic and
commercial potential of LX4211. The 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 those relating to
Lexicon's ability to successfully conduct clinical development of
LX4211 and preclinical and clinical development of its other
potential drug candidates, advance additional candidates into
preclinical and clinical development, obtain necessary regulatory
approvals, 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, that 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, 2013, 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.
SOURCE Lexicon Pharmaceuticals, Inc.