ADDED
BUSINESS Overview We are a late-stage biopharmaceutical company focused on developing orally administered therapies for metabolic and inflammatory diseases with the goal of improving patient outcomes.
Our lead product candidate, cadisegliatin (TTP399) , is a novel, small-molecule, liver-selective glucokinase activator (GKA) currently being evaluated in a Phase 3 clinical trial as a potential oral adjunctive therapy to insulin for the treatment of type 1 diabetes (T1D).
The Cadisegliatin as Adjunctive Therapy to Insulin in Participants with Type 1 Diabetes ("CATT1") Phase 3 clinical trial is a randomized, double-blind, placebo-controlled trial designed to evaluate the effect of cadisegliatin on hypoglycemia outcomes in patients with T1D.
The primary endpoint is the reduction in the frequency of Level 2 hypoglycemia (blood glucose 54 mg/dL) and Level 3 (severe) hypoglycemia over a six-month treatment period.
A key secondary endpoint is change in hemoglobin A1c (HbA1c), a standard measure of glycemic control, to assess cadisegliatin s potential to reduce hyperglycemia.
The CATT1 trial will randomize 150 patients with T1D on a 1:1:1 basis (50 patients per study arm) to receive 800 mg cadisegliatin daily, 800 mg cadisegliatin twice daily, or placebo.
In 2021, the FDA granted Breakthrough Therapy designation for cadisegliatin as an adjunctive therapy to insulin for the treatment of T1D.
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
A Phase 1 mechanistic study of cadisegliatin in patients with T1D showed no increased risk of ketoacidosis with cadisegliatin during acute insulin withdrawal in patients.
Additionally, a Phase 1 study in healthy male subjects to investigate the absorption, metabolism, and excretion of[ 14 C]- cadisegliatin following single dose oral administration (the "ADME study") was conducted.
REMOVED
BUSINESS Overview We are a clinical stage biopharmaceutical company focused on the development of orally administered treatments for metabolic and inflammatory diseases to minimize their long-term complications and improve the lives of patients.
Our lead product candidate, cadisegliatin (TTP399) , is an orally administered, small molecule, liver-selective glucokinase activator ( GKA ) that is a potential adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D").
On March 14, 2025, based upon the Company's submission of a complete response letter, the U.S.
Food and Drug Administration ("FDA") lifted the clinical hold that had been placed on the cadisegliatin development program in July 2024.
We plan to resume our Phase 3 trial ("the CATT1 trial") in the second quarter of 2025.
The CATT1 trial is a double-blind, randomized trial to assess the effect of cadisegliatin on reducing the frequency of Level 2 hypoglycemia (blood glucose levels are less than 54 mg/dL or 3 mmol/L, regardless of symptoms) and Level 3 hypoglycemia ("severe" hypoglycemia e.g., requiring assistance of another person).
Although we had planned to conduct the primary assessment of efficacy after 6 months and then continue to retain patients in the CATT1 trial for another 6 months to collect safety data, we plan to amend the protocol of the CATT1 trial to remove the second 6-month period, which will allow us to obtain topline data from the trial sooner and expedite the start of the required pivotal trials.
The FDA granted Breakthrough Therapy designation for cadisegliatin as an adjunctive therapy to insulin for the treatment of T1D in 2021.
The Breakthrough Therapy designation provides a sponsor with added support and the potential to expedite development and review timelines for a promising new investigational medicine.
Moreover, a Phase 1 mechanistic study of cadisegliatin in patients with T1D conducted to determine the impact of cadisegliatin on ketone body formation showed no increased risk of ketoacidosis with cadisegliatin during acute insulin withdrawal in patients with T1D.