SAN DIEGO, CA, USA I September 13, 2016 I 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.
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.
SOURCE: Ligand Pharmaceuticals
Published on Tuesday, 13 September 2016