vTv Therapeutics (vTv), a biopharmaceutical company developing an adjunctive therapy for type 1 diabetes (T1D), announced a $51 million financing round, including an investment from the Breakthrough T1D T1D Fund, Breakthrough T1D’s venture philanthropy arm.
vTv will use this financing to fund a phase III clinical trial of cadisegliatin (TTP399), an adjunct therapy to insulin for people with T1D. Per vTv, this trial is expected to begin in 2024.
Cadisegliatin is a liver-selective glucokinase (or GK) activator. GK in the liver and other organs acts as a critical regulator of sugar levels in the body. When blood sugar levels rise, activation of GK in the liver stimulates glucose utilization, lowering glucose levels in the blood. Cadisegliatin is administered as a tablet.
After completing several studies in participants with type 2 diabetes, vTv Therapeutics joined forces with Breakthrough T1D in 2017 to also test cadisegliatin in people with T1D. In the phase II clinical trial, called Simplici-T1, cadisegliatin significantly improved HbA1c in people with T1D. Additionally, trial participants who received cadisegliatin showed a reduction in insulin dose, reduced hypoglycemia (low blood sugar), and no increase in diabetic ketoacidosis (DKA).
Breakthrough T1D has funded studies into glucokinase since the early 1980s, including funding for Franz Matschinsky, M.D., who made the seminal discovery of glucokinase as the primary glucose sensor in the pancreas. With funding from Breakthrough T1D, he went on to collaborate with then-unknown scientists who today are leaders in the diabetes space, including Mark A. Magnuson, M.D., who is now the leading investigator on glucokinase activity, and Barbara Corkey, Ph.D., who is known for her pivotal work on obesity and diabetes.
Breakthrough T1D is excited that the Fund’s investment will continue this partnership and help move this promising therapy through the drug development pipeline into a phase III clinical trial.