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news.Israeli anti-microbial therapeutic firm Advanced Inhalation Therapies (AIT) has received orphan drug designation (ODD) from the European Commission for its high dose formulation of nitric oxide (NO) and delivery system, AIT-CF, to treat cystic fibrosis (CF).
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The orphan designation is held by the company’s European agent, Biological Consulting Europe, which is located in the UK.
Advanced Inhalation Therapies chief medical officer Dr David Greenberg said: "AIT-CF potentially affords a significant benefit to CF patients. As a naturally occurring chemical in the body, NO, when inhaled at high concentrations, kills bacteria and fungi in the lungs of CF patients and has shown broad anti-infective activity.
"The European orphan drug designation for AIT-CF affords additional benefits as we continue to advance its clinical development."
AIT-CF is designed to deliver a high dose formulation (160 ppm) to the lungs using positive air pressure and integrated monitoring parameters.
The new delivery system has the potential to reduce microbial infections including bacteria, fungi and viruses.
The company’s proprietary system continuously monitors safety and efficacy parameters in the patient and is adaptable to treat a wide range of lung infections.
Recently, the company had completed a Phase IIa trial in adult CF patients and in February 2015, the US Food and Drug Administration (FDA) had granted ODD to AIT-CF for adjunctive treatment of CF.