Date: 2018-03-06
Type of information: Licensing agreement
Compound: LGD-6972 (now RVT-1502)
Company: Ligand Pharmaceuticals (USA - CA) Roivant Sciences (USA - CA)
Therapeutic area: Metabolic diseases
Type agreement: licensing
Action mechanism:
- glucagon receptor agonist. Glucagon receptor antagonists are designed to lower glucose levels by reducing the production of glucose by the liver. LGD-6972 has been studied in previously-published preclinical and clinical studies. Presentations from 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 type 2 diabetes. 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. In a previous Phase 1a single-ascending dose clinical study, LGD-6972 was well-tolerated, with no clinically significant or dose-dependent changes in hematology, clinical chemistry or urinalysis panels, ECG or vital signs, and no serious adverse events. After a single dose, LGD-6972 reduced fasting plasma glucose in normal healthy volunteers and in subjects with type 2 diabetes; fasting plasma glucose was reduced by 57 mg/dL (placebo-adjusted) in subjects with type 2 diabetes.
- In single- and multiple-dose Phase 1 studies, LGD-6972 demonstrated favorable safety, tolerability and pharmacokinetics in normal healthy volunteers and in subjects with T2DM, and demonstrated a robust, dose-dependent reduction of fasting plasma glucose1. Baseline-adjusted glucose values showed dose-dependent effects of LGD-6972 on subjects with T2DM with a maximal decrease of 57 mg/dL after 14 days of treatment. The robust glycemic responses were not associated with dose-related or clinically meaningful changes in hematology, clinical chemistry including liver enzymes and lipids, urinalysis, electrocardiography or vital signs, and no subject experienced a hypoglycemic event during the 14-day treatment or follow-up periods.
- Safety and efficacy of LGD-6972 was evaluated in a Phase 2 clinical study as an adjunct to diet and exercise, in subjects with T2DM inadequately controlled on metformin monotherapy. The Phase 2 clinical study achieved statistical significance (p<0.0001) in the primary endpoint of change from baseline in HbA1c after 12 weeks of treatment at all doses tested, demonstrating a robust, dose-dependent reduction in HbA1c of 0.90%, 0.92% and 1.20% with 5 mg, 10 mg and 15 mg of LGD-6972, respectively, compared to a 0.15% reduction with placebo. LGD-6972 was safe and well tolerated, with no drug-related serious adverse events and no dose-dependent changes in lipids (including total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides), body weight or blood pressure after 12 weeks of treatment.
Disease: type 2 diabetes
Details:
- • On March 6, 2018, Ligand Pharmaceuticals announced the signing of a license agreement granting Roivant Sciences exclusive global rights to develop and commercialize LGD-6972, Ligand’s glucagon receptor antagonist (GRA).
- In September 2017 Ligand announced positive topline results from a Phase 2 clinical study evaluating the efficacy and safety of LGD-6972 as an adjunct to diet and exercise in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin monotherapy. Full data from the Phase 2 trial has been submitted for presentation at the 78th annual Scientific Sessions of the American Diabetes Association being held in Orlando from June 22-26, 2018.
- Roivant is a privately-held company that has established multiple subsidiary biopharmaceutical companies focused on distinct disease areas, each with dedicated leadership and development-stage programs. With its affiliates, Roivant has raised more than $2.7 billion in capital to date to fund clinical programs and pursue adjacent business opportunities in healthcare. Roivant recently formed Metavant Sciences to develop LGD-6972 (now RVT-1502) as well as imeglimin (RVT-1501), another novel clinical-stage oral antidiabetic therapy. Metavant is focused on addressing the significant unmet medical needs of patients with cardiometabolic disorders. Roivant is also evaluating additional assets for Metavant’s pipeline.
Financial terms:
- Under the terms of the agreement, Ligand will receive upfront license fees, and is eligible to receive clinical and regulatory milestone payments as well as sales-based milestone payments and royalties. Roivant will be responsible for all costs related to the program, effective immediately.
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