AIT Therapeutics Granted Orphan Drug Designation
AIT Therapeutics Inc. recently announced the US FDA has granted orphan drug designation to the company for its novel NO formulation for the treatment of infections caused by NTM.
The FDA’s Office of Orphan Drug Products grants orphan drug designation to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan drug designation will provide AIT Therapeutics with certain exclusivity benefits, tax credits for certain research, and a waiver of the New Drug Application user fees.
“Receiving orphan drug designation is an important regulatory milestone,” said Steve Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “NTM infection is a rare and debilitating pulmonary disease associated with increased morbidity and mortality. We are currently developing our nitric oxide therapy for two indications, and look forward to announcing data from our Phase 2 study in NTM abscessus during the fourth quarter of this year.”
Nitric oxide (NO) is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, NO is believed to play a key role in the innate immune system at concentrations of approximately 200 ppm. In vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria; both gram positive and gram negative, but also against other diverse organisms including mycobacteria, fungi, yeast, and parasites, and has the potential to eliminate their multi-drug resistant strains.
AIT Therapeutics Inc. is a clinical-stage biopharmaceutical company using nitric oxide (NO) to treat respiratory and other diseases. The Company is currently applying its therapeutic expertise to treat lower respiratory tract infections that are not effectively addressed with current standards of care. AIT Therapeutics is advancing its revolutionary NO respiratory targeted system in clinical trials for the treatment of bronchiolitis and nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.
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