vTv Therapeutics recently announced positive Phase 2 results for its oral antidiabetic drug, TTP-399, when used as an adjunct therapy to insulin in type 1 diabetes (T1D) patients. If the drug can show potential in allowing certain subsets of T1D patients to gain better glycemic and weight control, as well as potentially lower daily insulin dosages, the company could potentially become a strong player in the developing market, says GlobalData, a leading data and analytics company.

The multi-center, randomized, double-blind Phase 2 study, Simplici-T1, examined TTP-399 when used as an adjunct therapy to insulin in T1D patients. The study revealed that TTP-399 was effective in reducing HbA1c compared to placebo at 12 weeks in T1D patients on insulin (p=0.03). The first-in-class therapy works by conferring an insulin-independent mechanism of action and targets GK activation in the liver.

Jesus Cuaron, PhD, PPM, Associate Director at GlobalData, comments: “The highly competitive and saturated oral drug market for treating type 2 diabetes (T2D) patients is pushing some diabetes drug developers to focus more on T1D. Even among the T2D drug classes that were historically administered by injection only, the rise of Novo Nordisk’s oral glucagon like peptide-1 receptor agonist Rybelsus (semaglutide) for example, makes it increasingly difficult for a new oral therapy to enter the crowded market. But TTP-399 will have to come up against competitor drugs in the T1D arena, as the sodium–glucose cotransporters (SGLT) inhibitors are striving to gain a foothold in the T1D oral treatment space. 

“No SGLT inhibitor has been able to gain Food and Drug Administration (FDA) approval towards a T1D indication so far, leaving the oral T1D treatment space wide open in the US. In addition, Simplici-T1 showed that there were no cases of diabetic ketoacidosis in the TTP-399-treated and placebo-treated groups, indicating that this could be a point of major differentiation and competitive advantage due to worries over increased risk of diabetic ketoacidosis in patients receiving SGLT inhibitor treatment, a concern echoed by key opinion leaders (KOLs) interviewed by GlobalData.”