AIT Therapeutics Announces the Last Patient Has Completed Dosing in its Phase 2 NO-NTM Clinical Trial for Patients Suffering from Nontuberculous Mycobacteria (NTM) Abscessus
Data are expected before the end of 2017
NEW YORK, Oct. 23, 2017 (GLOBE NEWSWIRE) -- AIT Therapeutics Inc. (OTC:AITB), a clinical-stage biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with serious lung infections, today announced the last patient in its NO-NTM Phase 2 abscessus clinical trial has completed treatment. Data from the trial are expected to be communicated before the end of 2017.
“Our clinical and device teams have done an excellent job completing this trial,” said Steve Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “We are optimistic that our treatment will show promise in helping patients suffering from the effects of NTM abscessus infections.”
Nine patients completed the NO-NTM Phase 2 trial. All patients were refractory, based upon ATS/IDSA guidelines, to the standard-of-care, which consists of a combination of multiple antibiotics administered continually for at least 6 months and up to 2 years. In addition to the standard-of-care, patients received 160 ppm NO 5 times per day for 14 days, followed by 3 treatments per day for 7 days. The primary endpoint of the study is NO-related serious adverse events over the 21-day treatment period. Other data to be collected include Mycobacterium abscessus load in sputum, a 6-minute walk test, FEV1, and quality-of-life measurements.
NTM infection is a rare and serious condition causing debilitating pulmonary disease associated with increased morbidity and mortality. It is also an emerging public health concern worldwide because of its multi-drug antibiotic resistance. Current treatment guidelines suggest a combination of multiple, often toxic, antibiotics delivered continually over one to two years. These complex, expensive and invasive regimens have a poor record for the treatment of Mycobacterium abscessus. AIT’s system is designed to effectively deliver 160 ppm NO, which has been proven to eliminate bacteria, viruses, fungi and other microbes from the lungs and may work against antibiotic resistant bacteria.
About Nitric Oxide
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.
About AIT Therapeutics Inc.
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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Steven Lisi, Chief Executive Officer
AIT Therapeutics, Inc.
LifeSci Advisors, LLC
(646) 597 6989
Released October 23, 2017