Attgeno reports first healthy volunteers dosed with Supernitro in phase 1 trial

Attgeno AB today 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.

For further information, please contact

Per Agvald, CEO

Telephone: +46 706 457 827

E-mail: per.agvald@attgeno.com

Christofer Adding, CMO

Telephone: +46 707 886 766

E-mail: christofer.adding@attgeno.com

About Attgeno

Attgeno AB is a privately held Swedish pharmaceutical company to develop and commercialize the discovery of completely new methods to provide innovative and efficient nitric oxide-donating drugs. Its leading drug candidate Supernitro is currently in phase 1 clinical trials. For more information, please visit www.attgeno.com.

About Supernitro (PDNO)

Supernitro is administered as an intravenous infusion, and when entering into the blood, it has an ultra-short half-life rapidly releasing its active moiety nitric oxide (NO). As a result, the majority of its NO is released just through the short passage through the lung blood circulation where it reacts with the blood vessels and causes them to dilate. The dilation reduces the resistance for the blood flow through the lungs generated by the pumping of the right heart, and thereby the lung blood pressure is decreased. With decreased pressure to work against the right heart is alleviated. By the donation of NO in the lungs, Supernitro replaces the decrease in NO production that is a well-known consequence of different diseases leading to increased risk for acute pulmonary hypertension.

About acute pulmonary hypertension

Acute pulmonary hypertension, due to acute elicited constriction of the vessels in the lung blood circulation, is a feared complication to major surgery, especially heart surgery, lung emboli and severe infections e.g., Covid-19.  In acute pulmonary hypertension, constriction of blood vessels within the lung causes increased resistance in the lung blood vessels with a risk that the heart’s right ventricle does not have the capacity to sufficiently pump the blood through the lungs. In severe cases, the consequence is right heart failure and a drop in systemic blood pressure threatening blood flow to vital organs such as the brain, liver, kidneys and the heart itself – which can lead to a rapid death.