AIT Therapeutics has obtained a funding agreement that will raise $8 million through private investment in public equity (PIPE) financing to further development of its nitric oxide-based treatments for persistent pulmonary hypertension of the newborn, bronchiolitis, and nontuberculous mycobacteria.
Nitric oxide (NO) is a strong vasodilator that opens blood vessels, and is used to treat multiple respiratory conditions. At below 80 ppm (parts per million), NO acts as a vasodilator (increasing the width of blood vessels). In the lung, this reduces blood flow resistance, which increases oxygenation. At higher concentrations (approximately 200 ppm), NO is involved in the immune system in fighting infections.
Currently in hospitals, inhaled nitric oxide is administered in large, high-pressure cylinders, and there are concerns about the safety of transporting and maintaining these large devices. Also, issues with NO reacting with oxygen to create a toxic molecule, called nitrogen dioxide, have been reported.
The NO generator and delivery system developed by AI Therapeutics is cylinder-free, thus reducing the safety concerns and storage requirements of standard nitric oxide cylinders. This may enable NO treatment to be offered at home.
AIT’s device allows the delivery of NO at concentrations — above 80 ppm — required for the treatment of certain respiratory conditions, including bronchiolitis in the hospital setting, and chronic, refractory lung infections in the home setting. Furthermore, there is data showing that these devices reduce the risk of nitric dioxide exposure.
The NO generator and delivery system has been approved as a medical device by the U.S. Food and Drug Administration (FDA).
Inhaled NO is already an approved treatment for persistent PH, where NO’s vasodilation role is important.
Nontuberculous mycobacteria are currently treated with multiple antibiotics over a relatively long time period, but this approach is expensive, invasive, and often does not perform well. AIT Therapeutics plans instead to use the delivery of 160-400 ppm of NO to the lungs, as early evidence suggests this has a beneficial effect in patients with nontuberculous mycobacteria.
Finally, to treat bronchiolitis concentrations of nitric oxide greater than 80 ppm will be used. Again, early evidence indicates this has an anti-microbial effects in the lungs.
“I would like to thank those who have taken the time to investigate what we at AIT have created over the past 30 months with our proprietary nitric oxide generator and delivery system technology, and to understand the significant value creation for both patients and shareholders that will come with our continued execution over the next 18 months” Steve Lisi, chairman and CEO of AIT Therapeutics, said in a press release.
“This transaction will provide the funds needed to achieve our goals over the next 12 to 15 months of a PMA [pre-market approval] submission/FDA approval decision for persistent pulmonary hypertension of the newborn, completion of our bronchiolitis trial this winter, and the commencement of our at-home study in patients suffering from nontuberculous mycobacteria lung infection,” Lisi added.