Attgeno AB has this week announced that the first 8 healthy volunteers have been successfully dosed in a phase 1 clinical study with the company’s lead drug candidate, Supernitro. The trial continues according to the clinical protocol and will include up to 48 healthy volunteers.
“I am extremely proud that we have brought forward Attgeno’s proprietary drug candidate Supernitro for studies in humans. We have worked intensively for several years to develop a drug that meets the great need to selectively widen the blood vessels and improve the blood circulation through the lungs – without affecting the blood vessels in the rest of the body”, said MD PhD Per Agvald, CEO and co-founder of Attgeno.
The purpose of the phase 1 trial is to investigate the safety of Supernitro, and it is the first time the drug candidate has been administered to humans. To date, it has been administered to 8 subjects without any signs of side effects.
The fully financed study is structured in two parts:
Part I, in which each test person receives and infusion of one dose of Supernitro, and after 4 individuals are treated, an extensive evaluation is made to assess whether it is safe to proceed to the next, higher dose. This part of the study is planned to for a maximum of 9 dose levels.
Part II is designed to closely mimic how patients will be treated by gradually, in the study in three consecutive steps, increase the dose to a target dose that will be continued for three hours.
Results from the phase 1 trial are expected to be presented in Q4 2021.
“I believe that Supernitro holds the potential to benefit patients with life-threatening conditions associated with acute lung injury such as those that can be seen during severe infections, heart surgery and beyond”, said MD PhD Christofer Adding, CMO at Attgeno.