THE WOODLANDS, Texas,
Oct. 3, 2016 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that
data from its TELECAST Phase 3 study were presented at the 2016
Annual Symposium of the North American Neuroendocrine Tumor Society
(NANETS), held September 30 to October 1,
2016 in Jackson, Wyoming,
by Dr. Marianne Pavel in a
presentation, entitled "Efficacy and Safety Results of Telotristat
Ethyl in Patients with Carcinoid Syndrome During the Double-blind
Treatment Period of the TELECAST Phase 3 Clinical Trial."
The Phase 3 TELECAST study was designed as a companion to
Lexicon's pivotal Phase 3 TELESTAR study primarily to provide
additional safety exposure while further evaluating the activity of
telotristat ethyl (previously referenced as telotristat etiprate,
for telotristat ethyl hippurate) in carcinoid
syndrome. TELECAST mostly enrolled patients treated with
somatostatin analog (SSA) therapy, the current standard of care,
with carcinoid syndrome characterized by less severe bowel movement
frequency than those patients in TELESTAR (which required that
patients have an average of at least four bowel movements a day to
qualify for the study), but also enrolled a smaller number of
carcinoid syndrome patients not treated with SSA therapy.
Safety and tolerability was one of the primary objectives of the
TELECAST study, and telotristat ethyl was well tolerated during the
double-blind treatment period. Across all three treatment arms
(placebo, 250 mg, 500 mg, each taken three times daily), the
incidence of treatment-emergent adverse events (AEs) were 80.8%,
100% and 84.0%, respectively; the incidence of serious AEs (SAEs)
were 19.2%, 4.0% and 8.0%, respectively; and discontinuation due to
AEs were 3.8%, 8.0% and 0%, respectively. AEs of depression
or depressed mood were seen in two patients (7.7%) in the placebo
arm and one (4.0%) in each of the telotristat ethyl treatment arms.
Gastrointestinal AEs were seen in 57.7%, 64.0% and 36.0% of
patients in the placebo, 250 mg and 500 mg treatment arms,
respectively.
Telotristat ethyl met the study's primary efficacy endpoint, the
percent change from baseline in urinary 5-hydroxyindoleacetic acid
(5-HIAA, the main metabolite of serotonin) at week 12, the final
week of the double-blind treatment portion of the study (p<0.001
for both telotristat ethyl arms compared to placebo). The
placebo-adjusted change in 5-HIAA was -54.0% and -89.7% for the 250
mg and 500 mg treatment arms, respectively.
In addition, despite the lower baseline bowel movement frequency
than in TELESTAR, telotristat ethyl achieved statistically
significant reductions in daily bowel movement frequency over the
12 weeks of the study (p=0.004 for the 250 mg treatment arm and
p<0.001 for the 500 mg treatment arm compared to placebo).
Baseline mean daily bowel movement frequency was 2.2, 2.5 and
2.8 in the placebo, 250 mg and 500 mg arms. Patients in the
250 mg and 500 mg dose arms experienced noteworthy reductions in
daily bowel movement frequency early in the study that tended to
increase over time. The placebo-adjusted reduction in daily
bowel movement frequency over the entire 12-week period was -0.45
and -0.54 for the 250 mg and 500 mg treatment arms,
respectively.
Notably, 40% of patients in each of the telotristat ethyl
treatment arms achieved a ≥30% reduction in BM frequency for at
least 50% of the days in the double-blind treatment period, while
not a single patient in the placebo arm achieved that result
(p=0.001 for both doses compared to placebo).
About Carcinoid Syndrome
Carcinoid syndrome is a rare disease affecting thousands of
cancer patients with metastatic neuroendocrine tumors (mNETs) that
have spread to the liver and other organs from the gastrointestinal
tract. The condition is characterized by frequent and debilitating
diarrhea that often prevents patients from leading active,
predictable lives, as well as by facial flushing, abdominal pain,
fatigue and, over time, heart valve damage.
About TELECAST and TELESTAR
The double-blind Phase 3 TELECAST study enrolled 76 patients
with or without concomitant SSA therapy provided they qualified
based on at least one sign/symptom of carcinoid syndrome, signs and
symptoms of carcinoid syndrome, relating to either flushing,
gastrointestinal symptoms, or elevated urinary 5-HIAA. The
three-arm study evaluated two doses of oral telotristat ethyl – 250
mg and 500 mg, each taken three times daily – against placebo over
a 12-week period with primary outcome measures consisting of safety
and the percent change from baseline in urinary 5-HIAA, and
secondary outcome measures including change from baseline in the
number of daily bowel movements. Patients in both the treatment and
placebo arms who were on SSA therapy at baseline continued their
SSA therapy throughout the study.
Results from Lexicon's pivotal Phase 3 TELESTAR study were
presented in 2015 at the European Cancer Congress and the annual
symposium of the North American Neuroendocrine Tumor Society.
About Telotristat Ethyl
Discovered using Lexicon's unique approach to gene science,
telotristat ethyl is the first investigational drug in clinical
studies to target tryptophan hydroxylase, an enzyme that triggers
the excess serotonin production within mNET cells that is a key
driver of carcinoid syndrome. While existing treatments for
carcinoid syndrome work to reduce the release of serotonin outside
tumor cells, telotristat ethyl works at the source to reduce
serotonin production within the tumor cells. By specifically
inhibiting serotonin production, telotristat ethyl seeks to control
this important driver of carcinoid syndrome and, in combination
with SSA therapy, the current standard of care, to provide patients
with more control over their disease.
Telotristat ethyl has received Fast Track and Orphan Drug
designation from the U.S. Food and Drug Administration and has been
granted priority review by the FDA with a Prescription Drug User
Fee Act (PDUFA) target action date of February 28, 2017.
Lexicon retains rights to market telotristat ethyl in the U.S.
and Japan, and is building the
in-house commercial infrastructure to serve the U.S. market.
Lexicon has a license and collaboration agreement with Ipsen to
commercialize telotristat ethyl in Europe and other countries outside the U.S.
and Japan.
About Lexicon
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. Lexicon has a pipeline of promising drug candidates
in clinical and pre-clinical development in oncology, diabetes and
metabolism. For additional information please visit
www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's clinical development of
telotristat ethyl (formerly referred to as telotristat etiprate and
LX1032) and the results of and projected timing of clinical trials
and the potential therapeutic and commercial potential of
telotristat ethyl. 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 telotristat ethyl 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 telotristat ethyl 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 telotristat ethyl. As a
result, telotristat ethyl 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, 2015, 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.