Israeli biopharmaceutical company Advanced Inhalation Therapies (AIT), which recently received orphan drug status in Europe for its inhaled nitric oxide for the treatment of cystic fibrosis, has filed with the US Securities and Exchange Commission (SEC) for an initial public offering. The company is looking to raise up to $36 million to support Phase 2 development of its NOx products for bronchiolitis, pneumonia, and asthma in addition to CF.
According to the filing, the “system is designed to safely deliver a high dosage of NO to the lungs, that, for the first time, has the potential to eliminate microbial infections including bacteria, fungi and viruses. This is in contrast to the current U.S. Food and Drug Administration (FDA) approved 20 ppm NO vasodilation treatment which is ineffective in treating microbial infections. NO is produced naturally by the body as an effective innate immunity mechanism. In order to combat severe infections, however, as demonstrated in clinical trials, higher concentrations of an NO formulation are required. To date no NO formulation and delivery system is approved by the FDA to deliver a high antimicrobial dosage to the lungs.”
AIT, which plans to trade on the NASDAQ exchange under the symbol AITP, has also received orphan designation from the FDA for the CF indication. Phase 2a studies have been completed for the CF and bronchiolitis indications. The company is also developing a pulmonary delivery system for nitric oxide for hospital use.
Read the AIT filing.
