Under terms of the deal for the system, called eNOGenerator, AIT will pay NitricGen a total of $2 million in up-front, clinical and regulatory milestone payment. In return, AIT gets all related intellectual property, trade secrets, know-how and confidential information.
“This system has the potential to be transformative for the delivery of NO in any setting, and we have already completed the vast majority of our commercial manufacturing process,” AIT Chairman and CEO Steve Lisi said in a press release.
The company, based in Harrison, New York, expects the new system to be available in 2019 for newborns with primary PH. Bronchiolitis patients should benefit from the system starting in 2020, while those with nontuberculous mycobacteria (NTM) infections of the lung should expect it in 2021, Lisi said.
NO acts at the molecular, cellular and physiologic levels. Research suggests that, in the airways, NO plays a critical role in the innate immune system at concentrations of about 200 parts per million (ppm), and is an effective vasodilator in pulmonary blood vessels at concentrations below 80 ppm.
In vitro data also indicate that NO has anti-microbial activity against diverse and less common types of bacteria as well as fungi, yeast and parasites. Importantly, NO may eliminate multi-drug resistant strains.
The eNOGenerator system can generate nitric oxide on demand and deliver it to the lungs at concentrations ranging from 1 to 400 ppm. It can also target all conditions that require NO — intermittently or continuously — regardless of the required dose. In addition, its weight of only six pounds makes it easier to use at home, and far more convenient than large, high-pressure NO cylinders.
Doctores recently used eNOGenerator to treat a patient with a multi-drug resistant subtype of NTM at the National Institutes of Health under “compassionate use” – which refers to unapproved drugs used outside clinical trials. The patient safely completed 91 treatments of half an hour each over 21 days. Subsequent treatments will be conducted over the next few months.