Attgeno AB today announced that it has received approval from the Swedish Medical Products Agency and the Swedish Ethical Review Authority to start a phase 2 clinical trial of its lead drug candidate Supernitro as a potentially lifesaving treatment for patients with acute pulmonary hypertension after cardiac surgery.
The Phase 2 study is an open-label, multi-centre, Phase 2 clinical trial to assess the safety and the dose-range efficacy of Supernitro on pulmonary vascular resistance (PVR) in patients with post-operative acute pulmonary hypertension. An acute increase in PVR after cardiac surgery is a feared condition that can lead to right heart failure and death. Supernitro is a new intravenous drug candidate that delivers nitric oxide (NO) to selectively reverse acute pulmonary hypertension.
Approval to start the Phase 2 study has been secured following the completion of all necessary safety and efficacy testing of Supernitro, including a recent successful Phase 1 study in healthy subjects. The study is planned to start in June 2022, enrolling up to 24 patients at the Sahlgrenska and Örebro University hospitals in Sweden, and results are expected by the end of 2022. Given that the study shows positive outcomes, Attgeno will aim to start a pivotal 3 study as soon as possible, including involvement of clinics in the US.
“Approval to start the phase 2 study is major milestone achievement for the company that since the study will help to provide a framework for the pivotal clinical development programme. This is the regulatory proof that the Supernitro technology is safe and tolerable and has potential to be a life-saving treatment,” says Per Agvald, CEO and co-founder of Attgeno.
The advantage of Supernitro, when infused into blood vessels, is that it releases nitric oxide extremely fast and can therefore be targeted to a specific organ. Intravenous infusion of Supernitro affects blood circulation in the lungs, where nitric oxide is released and dilates the blood vessels to counteract acute pulmonary hypertension. However, the dilatory effect of nitric oxide on lung blood circulation cannot be studied in healthy individuals.
“The reason for this is that the blood vessels in a healthy subject’s lungs are almost fully dilated and PVR is very low due to intact endogenous endothelial nitric oxide production. In most cardiopulmonary disease there is deficient nitric oxide production in the lungs, and pulmonary hypertension develops. Thus, to evaluate the effect of Supernitro on pulmonary circulation, tests must be performed on patients with acute pulmonary hypertension. Patients undergoing elective cardiac valve surgery are prone to develop this condition,” says Christofer Adding, CMO and co-founder of Attgeno.
Attgeno believes the study will confirm a selective effect on lung blood circulation and find suitable doses to design the pivotal randomised controlled trial studies needed for market authorisation.
“Attgeno’s invention, Supernitro, seems to have huge potential, not only in the treatment of life-threatening conditions when cardiac surgery with cardiopulmonary bypass elicits acute pulmonary hypertension, but also in several other diseases associated with increased risk of right heart failure. For decades, the scientific community has searched for a selective pulmonary vasodilator that could be administered intravenously, and if Supernitro really has this property in humans it should represent an enormous therapeutic advance,” says Sven-Erik Ricksten, professor in thoracic anaesthesiology at the Sahlgrenska Hospital, Gothenburg