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. Further details regarding the transaction and an update to Ligand’s 2018 guidance are provided in Ligand’s Form 8-K being filed today with the Securities and Exchange Commission (SEC).
LGD-6972 is a novel, potent, oral, small-molecule 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.
Ligand Pharmaceuticals CEO John Higgins said: "This global license with Roivant for our diabetes program is another important deal in a long history of success converting our inventions, data and intellectual property into licenses to advance promising medicines and deliver value to our shareholders.
"Roivant is well capitalized and they are assembling an experienced team at Metavant to efficiently drive the program forward. This is a major partnership that has the potential to generate substantial medical value for both type 1 and type 2 diabetes patients.
“If LGD-6972 is successfully developed, this license with Roivant has the potential to be Ligand's largest financial asset with the possibility of annual royalties into the late 2030s given current and pending IP."
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.
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 due in part to inappropriately elevated levels of glucagon. GRAs are designed to lower glucose levels by reducing the production of glucose by the liver.
Other small-molecule GRAs have demonstrated a reduction of glucose and hemoglobin A1c (HbA1c) in mid-stage clinical trials, but also produced dose-dependent or significant side effects, such as increases in LDL cholesterol, body weight and blood pressure, that have impeded further clinical development.
LGD-6972 is a small-molecule GRA. Based in part on unique elements of the chemical structure of LGD-6972 compared with other small molecules that have been tested clinically, Ligand believes LGD-6972, if approved, could potentially be a valuable addition to the armamentarium of treatments for diabetes.
LGD-6972 has been studied in preclinical and Phase 1 and Phase 2 clinical studies in subjects with T2DM. 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 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 was shown in this model to have additive effects when used in combination with insulin therapy, suggesting it may also be useful in an insulin-sparing regimen.