Ligand Initiates Phase 2 Trial with LGD-6972 in Type 2 Diabetes
September 13 2016 - 8:30AM
Business Wire
Ligand Pharmaceuticals Incorporated (Nasdaq: LGND)
announces the initiation of a Phase 2 clinical trial with the
Company’s glucagon receptor antagonist LGD-6972 for the treatment
of type 2 diabetes mellitus (T2DM). This randomized, double-blind,
placebo-controlled study will evaluate the safety and efficacy of
LGD-6972, as an adjunct to diet and exercise, in subjects with T2DM
whose blood glucose levels are inadequately controlled with
metformin.
The multiple site study is expected to enroll 148 subjects with
T2DM who will be treated with one of 3 doses of LGD-6972 (5 mg, 10
mg, or 15 mg) or placebo once daily for 12 weeks. The primary
endpoint of the study is the change from baseline in hemoglobin
A1c. Secondary endpoints include the change from baseline in
fasting plasma glucose, insulin, glucagon and GLP-1, as well as
changes in lipids, blood pressure and body weight. Up to 30
clinical sites located across the U.S. will be participating in the
study, which Ligand estimates will be completed in late 2017.
“We are pleased to be initiating the Phase 2 trial for LGD-6972
and to continue to build upon the dataset we’ve assembled for this
important asset. Glucagon antagonism has continued to emerge as a
leading non-insulin mechanism for type 2 diabetes,” said John
Higgins, Chief Executive Officer. “We look forward to obtaining
data next year, and to potential future partnering of this asset,
consistent with our shots-on-goal business model.”
Glucagon receptor antagonists are a leading non-insulin
mechanism in development for the treatment of T2DM. Based on the
Phase 1 trial results that were published online in Diabetes,
Obesity and Metabolism in August1, Ligand believes LGD-6972 could
have best-in-class properties given its potency in lowering plasma
glucose in patients with T2DM and its preliminary safety
profile.
About Ligand’s Glucagon Receptor Antagonist Program
Glucagon is a hormone produced by the pancreas that stimulates
the liver to produce glucose (sugar). Overproduction of glucose by
the liver is an important cause of high glucose levels in patients
with T2DM and is believed to be due in part to inappropriately
elevated levels of glucagon. Glucagon receptor antagonists are
designed to lower glucose levels by reducing the production of
glucose by the liver. Glucagon receptor antagonists are novel
molecules that have demonstrated a reduction of glucose and
hemoglobin A1c (HbA1c) in mid-stage clinical trials.
Preclinical studies have shown that LGD-6972 is highly potent
and selective and inhibits glucagon-induced hyperglycemia in both
rats and monkeys, and that it also significantly lowers glucose in
a mouse model of T2DM. Additionally, LGD-6972 significantly lowered
fasting and non-fasting glucose levels in a mouse model of type 1
diabetes and also reduced HbA1c, ketone bodies and free fatty
acids. LGD-6972 also has been shown to have additive effects when
used in combination with insulin therapy and may also be useful in
an insulin-sparing regimen.
About Diabetes
Diabetes is a growing global epidemic that currently affects
more than 415 million people worldwide2. In North America,
approximately 44 million people have diabetes2. If current trends
continue, by 2050 fully 33% of the U.S. population will be
affected3. People with T2DM either are resistant to the effects of
insulin or do not produce enough insulin to maintain a normal
glucose level. Sustained high glucose levels can cause diabetic
complications such as heart disease, stroke, kidney failure,
neuropathy, lower-limb amputations and blindness. Although T2DM is
more common in adults, it increasingly affects children as
childhood obesity increases. An estimated 90% to 95% of Americans
with diabetes have T2DM4.
The market for diabetes drugs is expected to nearly double to
$68 billion by 20225 as treatment paradigms shift toward
combination therapies and novel non-insulin drugs. The top 10
non-insulin diabetes drugs had total sales of $12 billion in 2014,
and sales are expected to increase to $20 billion by 20206.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on developing or
acquiring technologies that help pharmaceutical companies discover
and develop medicines. Our business model creates value for
stockholders by providing a diversified portfolio of biotech and
pharmaceutical product revenue streams that are supported by an
efficient and low corporate cost structure. Our goal is to offer
investors an opportunity to participate in the promise of the
biotech industry in a profitable, diversified and lower-risk
business than a typical biotech company. Our business model is
based on doing what we do best: drug discovery, early-stage drug
development, product reformulation and partnering. We partner with
other pharmaceutical companies to leverage what they do best
(late-stage development, regulatory management and
commercialization) to ultimately generate our revenue. Ligand’s
Captisol® platform technology is a patent-protected, chemically
modified cyclodextrin with a structure designed to optimize the
solubility and stability of drugs. OmniAb® is a patent-protected
transgenic animal platform used in the discovery of fully human
mono- and bispecific therapeutic antibodies. Ligand has established
multiple alliances, licenses and other business relationships with
the world's leading pharmaceutical companies including Novartis,
Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter
International and Eli Lilly.
Follow Ligand on Twitter @Ligand_LGND.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand
that involve risks and uncertainties and reflect Ligand's judgment
as of the date of this release. These include statements regarding
the timing, size, number of clinical sites, and protocol for the
Phase 2 trial with LGD-6972, the potential for LGD-6972 to treat
patients with type 2 diabetes, the potential for LGD-6972 to be a
best-in-class treatment option for T2DM, the anticipated safety and
pharmacological profile in future clinical trials, the number of
patients affected by diabetes, the number of patients who may be
affected by diabetes in the future, the annual total sales of
non-insulin diabetes drugs and the expected future sales of such
drugs. Actual events or results may differ from our expectations.
For example, Ligand may be unable to enroll a sufficient number of
patients in the Phase 2 clinical trial for LGD-6972, or otherwise
be unable to complete the Phase 2 trial for a number of reasons
beyond Ligand’s control, including reported adverse side effects
from the trial or additional data regarding LGD-6972; there can be
no assurance that the Phase 2 trial will meet its primary or
secondary endpoints; even if the Phase 2 trial is successful, there
can be no assurance of success in future clinical trials; the
safety and tolerability data from a new clinical trial in LGD-6972
may conflict with the results of the Phase 1 clinical trials; the
number of patients diagnoses with diabetes may be more or fewer
than Ligand believes; and the total sales of non-insulin diabetes
drugs is dependent on market acceptance of such drugs. The failure
to meet expectations with respect to any of the foregoing matters
may reduce Ligand's stock price. Additional information concerning
these and other important risk factors affecting Ligand can be
found in Ligand's prior press releases available at www.ligand.com
as well as in Ligand's public periodic filings with the Securities
and Exchange Commission, available at www.sec.gov. Ligand disclaims
any intent or obligation to update these forward-looking statements
beyond the date of this press release, except as required by law.
This caution is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
References
- Eric G. Vajda, et al. Pharmacokinetics
and pharmacodynamics of single and multiple doses of the glucagon
receptor antagonist LGD-6972 in healthy subjects and subjects with
type 2 diabetes mellitus, Diabetes Obes Metab 2016, 9999, n/a.
DOI:10.1111/dom.12752
- Diabetes: Facts and Figures.
International Diabetes Federation website.
http://www.idf.org/about-diabetes/facts-figures.
- James P Boyle, et al. Projection of the
year 2050 burden of diabetes in the U.S. adult population: dynamic
modeling of incidence, mortality, and prediabetes prevalence.
American Diabetes Association, Population Health Metrics. 2010 Oct
22;8:29
- 2014 National Diabetes statistics
report. Centers for Disease Control and Prevention website.
http://www.cdc.gov/diabetes/data/statistics/2014StatisticsReport.html.
- Type 2 Diabetes-Global Drug Forecast
& Market Analysis to 2022. GlobalData
- Thomson Reuters Cortellis, 2020 sales
based on analyst consensus projections, 2015
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Ligand Pharmaceuticals IncorporatedTodd Pettingill,
858-550-7500investors@ligand.comorLHABruce Voss,
310-691-7100bvoss@lhai.com
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