The last of 38 study participants were treated with Supernitro on 18 May, and the substance has shown good safety and tolerability.
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), states the company.
The results pave the way for the next step in Attgeno’s development programme, where patients suffering from acute high blood pressure in the lungs, so called acute pulmonary hypertension (APH) following heart surgery, will be treated with Supernitro.
Allow continued studies
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, and all study participants received both Supernitro and a placebo. 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 APH.
“It has been exciting for us to be part of Attgeno’s study as the effect of Supernitro by intravenous infusion can happen very quickly, which is a potential benefit for use in intensive care. Previously, releasing NO to the pulmonary circulation by inhalation has been tested extensively, but without producing a sufficient effect on the pulmonary vessels in pulmonary hypertension. Supernitro is especially promising as it tackles the problem from the ‘right’ direction, i.e. that the NO from the substance is released from the vessel side, and it is also really potent,” explains anaesthesiologist Folke Sjöberg, who is medically responsible for the study at CTC Clinical Trial Consultants in Uppsala.