Clinical safety evaluation of Supernitro- a novel treatment against acute pulmonary hypertension
| Reference number | |
| Coordinator | Attgeno AB |
| Funding from Vinnova | SEK 5 000 000 |
| Project duration | November 2018 - December 2021 |
| Status | Completed |
Purpose and goal
The primary purpose of this study, which is the first in which Supernitro was given to humans, was to evaluate the tolerability and safety of intravenous infusion. The side effects that were observed were expected and in accordance with the substance mechanism of action. The conclusion from Attgeno is that the safety of Supernitro is sufficient to now allow continued studies with Supernitro in patients with acute pulmonary hypertension in heart surgery patients.
Expected results and effects
In total 38 study participants have been treated in the Vinnova sponsored safety study of intravenous administered Supernitro. The results are in line with the expectations i.e. the substance has shown good safety and tolerability and no unexpected side effects have been reported. At a higher dose and longer treatment, the expected side effects have been noted in line with the substance mechanism of action vasodilation through the release of nitric oxide (NO). The results pave the way for the next step in the development of Supernitro as a new treatment of pulmonary hypertension.
Planned approach and implementation
The aim of the project was to carry out a single-blind placebo-controlled safety study where increased doses of Supernitro would be given to healthy study subjects under strict control of blood pressure and well-being. During and after the experiments, blood samples have been taken to check health and to analyze the levels of 1,2-propanediol in the blood. The project has taken longer to complete and has become significantly more expensive than expected, which i.a. due to unexpected problems related to the production of the study drug as well as delays related to the Covid-19 pandemic.