An oral small molecule, adjunct therapy to insulin in patients with type 1 diabetes (T1D).
Phase 3
TTP399
Overview:
vTv’s TTP399 is a novel, oral, small molecule, liver selective glucokinase activator being developed as an adjunct therapy to insulin in patients with T1D to reduce the occurrence of hypoglycemic episodes. TTP399 restores the normal function of the liver in the presence of high glucose by trapping glucose inside liver cells, promotes further glucose uptake for energy and storage, and keeps the liver in a “fed” state to prevent ketone production.
In its phase 2 study with T1D patients, TTP399 showed a 40% reduction in hypoglycemic episodes compared to placebo when used as adjunctive treatment to insulin therapy, as well as meaningful improvement to HbA1C. In April 2021, the FDA granted Breakthrough Therapy designation to TTP399 for the treatment of T1D. This past October, vTv announced results of a mechanistic study of TTP399 in patients with T1D demonstrating no increased risk of ketoacidosis. TTP399 has now been tested in almost 600 subjects and demonstrated a good safety and tolerability profile.
TTP399 will be studied in additional clinical trials to be initiated in 2023.
Sources:
https://www.jdrf.org/t1d-resources/about/facts/
https://care.diabetesjournals.org/content/44/11/2449
REASONS
TO BELIEVE
- Hypoglycemic events in people with Type 1 diabetes is a major burden for patients and their families
- TP399 received Breakthrough Therapy Designation by the FDA in 2021, signaling the FDA’s recognition TTP399 may make an impact on the clinical paradigm
- TTP399 has been studied in 13 trials (3 Phase 2) with no significant safety issues, particularly no evidence of risk of DKA
- In 2019 the Endocrine Society made reducing hypoglycemia a strategic priority
- An effective oral pill is a significant advancement and advantage over injections