Mycobacterium Abscessus Load Reduced by 65%
NEW YORK, Jan. 22, 2018 (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 and pulmonary hypertension, today announced positive data at Day 81, the end of its NO-NTM Abscessus clinical trial. The Company previously announced positive preliminary data through Day 51.
“We continue to be delighted with the data from this trial. With just 21 days of treatment patients are still benefitting at Day 81 as shown by 6-minute walk data. Additionally, the anti-microbial effect of NO is apparent with qPCR showing a 65% reduction in bacterial load,” said Steve Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “Our proprietary system with our NO generator may allow AIT to treat patients at home for an extended period of time, possibly at a higher NO concentration, potentially improving on the strong results shown in our completed study.”
All patients in the trial were refractory to the standard-of-care for NTM abscessus (MABSC) and had underlying cystic fibrosis. Patients were treated with inhaled NO in addition to background antibiotic therapy at the physicians’ discretion. NO was delivered at a concentration of 160ppm for 30 minutes intermittently for 21 days (5 times a day for 14 days and then 3 times per day for a subsequent 7 days), after which no further NO treatments were provided. As per the protocol, all patients were followed for 81 days.
Mycobacterium abscessus load, as measured by quantitative PCR (qPCR), showed a mean reduction of 65% at Day 81 versus baseline. Data for 6-minute walk and FEV1% are shown in Figures 1 and 2, respectively.
Andrew Colin, M.D., Director, Division of Pediatric Pulmonology at the University of Miami, and the Principal Clinical Consultant of the NO-NTM study opined, “The benefits of nitric oxide are clearly demonstrated in this trial.” Dr. Colin further added, “MABSC patients at this level of severity, mostly have a downhill trajectory and very limited therapeutic options. The possibility of using AIT’s system to treat patients chronically, at home, is a very promising development. I am looking forward to assisting AIT in getting their system approved, and use it to study a broader array of patients with cystic fibrosis and other chronic lung diseases.”
AIT plans to meet with the United States Food and Drug Administration (FDA) in the second quarter of 2018 to discuss the plans for a pivotal trial that will allow AIT to gain regulatory approval to help combat the effects of NTM infections. Based on feedback from this upcoming meeting, AIT will provide more specific timing for the commencement of a pivotal trial. AIT is enthusiastically committed to developing NO therapy to help patients suffering from NTM.
About Mycobacterium abscessus complex (MABSC) of the Lungs
MABSC is the most aggressive and difficult to treat form of non-tuberculous mycobacteria (NTM). There are currently no approved treatments for MABSC. Current standard-of-care is a cocktail of antibiotics that often proves to be ineffective with severe adverse effects. Most patients suffering from MABSC have an underlying disease, such as cystic fibrosis or chronic obstructive pulmonary disease (COPD). The median survival of those suffering from MABSC is less than 5 years.
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. At concentrations below 80 ppm, NO has proven to be an effective vasodilator in the pulmonary vasculature.
About AIT Therapeutics Inc.
AIT Therapeutics Inc. is a clinical-stage biopharmaceutical company using nitric oxide (NO) to treat serious lung infections and pulmonary hypertension. 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 for nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.
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