Clinical safety evaluation of Supernitro- a novel treatment against acute pulmonary hypertension
|Funding from Vinnova||SEK 5 000 000|
|Project duration||November 2018 - November 2020|
|Venture||SWElife Phase 2 2017|
Purpose and goal
Acute pulmonary hypertension is a life-threatening condition, in which the blood vessels of the lung contract so that the heart cannot pump the blood through the lungs. The result is acute heart failure and death. The condition may occur in conjunction with blood cloth in the lung, sepsis or after major surgery. Supernitro is a new drug that selectively donates NO to the lung vessels to widen them. The aim is to carry out safety studies on healthy subjects and then treat patients affected by pulmonary hypertension.
Expected results and effects
Supernitro is rapidly converted to NO,which is produced by the human body, and propylene glycol, previously used as carrier solution in various intravenous drugs and well tolerated by humans. The expected outcome is that Supernitro does not have any adverse effects and that Attgeno thereby receives permission to proceed and test the drug in patients with pulmonary hypertension.
Planned approach and implementation
In order to give Supernitro to humans, the production of the drug has to be further refined and every part of the process must be quality assured according to GLP standard and this part of the project will start immediately. Once the production of Supernitro is completed, attempts on healthy subjects will begin, initially given low concentrations for a short period of time but increasing the dose if no serious side effects occur. In the end, a group of subjects will receive a 24 hour infusion of Supernitro.