In short
Inositol trispyrophosphate hexasodium (ITPP) is an investigational chemical substance studied as an add-on treatment to improve breathing in severe lung infections. It has no marketing authorisation. Two clinical trials are registered: one completed Phase 2 trial in 100 patients with COVID-19 and other lung infections, and one authorised Phase 4 trial in 224 patients with metastatic breast cancer.
Key points
- Inositol trispyrophosphate hexasodium (ITPP) is an investigational substance with no marketing authorisation.
- It was tested in a Phase 2 trial as an intravenous infusion for respiratory failure in COVID-19 and other lung infections.
- The Phase 2 trial enrolled 100 participants and is completed.
- A separate Phase 4 trial is studying an oral form called TherO2-01S22 in metastatic breast cancer.
- The breast cancer trial plans to enrol 224 participants and is authorised.
- The Phase 2 trial measured improvement in respiratory capacity through gasometric and biochemical parameters.
What is inositol trispyrophosphate hexasodium?
Inositol trispyrophosphate hexasodium (ITPP) is a chemically synthesised substance. It is an investigational substance with no marketing authorisation in the product records. In the registered trials it appears under the product name OXY111A when given by infusion, and as TherO2-01S22 when given by mouth. The substance is supplied by the Wojskowy Instytut Medyczny–Państwowy Instytut Badawczy.
How does inositol trispyrophosphate hexasodium work?
The registry records do not describe a molecular target or mechanism of action for inositol trispyrophosphate hexasodium. The Phase 2 trial describes it as an adjunctive treatment intended to improve respiratory capacity in progressive respiratory failure, measured by gasometric and biochemical parameters.
Which conditions is it used or studied for?
- COVID-19 and other pulmonary parenchymal infections — studied as an add-on treatment for progressive respiratory failure in a completed Phase 2 trial.
- Metastatic breast cancer — studied as an oral add-on to first-line anti-HER2 targeted treatment in an authorised Phase 4 trial.
How is inositol trispyrophosphate hexasodium given?
In the Phase 2 trial, inositol trispyrophosphate hexasodium (OXY111A) was given as a solution for infusion by intravenous use at a dose of 5 grams. In the breast cancer trial, an oral form (TherO2-01S22) was given at a dose of 6 grams.
What do the clinical trials show?
Two interventional trials are registered for inositol trispyrophosphate hexasodium. One is a completed Phase 2 trial in 100 participants with COVID-19 and other pulmonary parenchymal infections. The other is an authorised Phase 4 trial planning to enrol 224 participants with metastatic breast cancer.
What are the trials measuring?
The Phase 2 trial measured improvement of respiratory capacity through gasometric and biochemical parameters. The Phase 4 trial measures the objective response rate (ORR), which is the percentage of patients whose disease decreases or disappears after treatment, assessed by RECIST V1.1 criteria and PET scan.
Who can take part in these trials?
The Phase 2 trial enrolled patients with progressive respiratory failure due to COVID-19 or other pulmonary parenchymal infections. The Phase 4 trial enrols patients with metastatic breast cancer receiving first-line anti-HER2 targeted treatment.
What side effects are known?
No side effect information is provided in the registry records for inositol trispyrophosphate hexasodium.