AIT Therapeutics Presented Data From Inhaled Nitric Oxide Study
AIT Therapeutics, Inc., a clinical-stage medical device and biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions including serious lung infections and pulmonary hypertension, recently announced the results of its study titled Nitric Oxide Inhalations in CF Patients Infected with Mycobacterium Abscessus Complex: A Prospective, Open-Labeled Multi-Center Pilot Study at the 2018 American Thoracic Society (ATS) Conference in San Diego, CA.
“The data presented demonstrate the promise of NO for the treatment of patients with MABSC as well as Pseudomonas aeruginosa infections,” said Steven Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “We will meet with the FDA later this quarter to discuss the path forward towards regulatory approval. With our generator-based NO delivery system we endeavor to treat patients in their homes for chronic, severe, refractory bacterial lung infections and hopefully improve upon the results just shown.”
Andrew Colin, MD, Director, Division of Pediatric Pulmonology at the University of Miami, and the Principal Clinical Consultant of the study, stated, “the results of this study confirm the benefits of nitric oxide for patients suffering from MABSC and provide a glimpse into the potential for nitric oxide to benefit patients with other severe bacterial infections.” Dr. Colin further added, “I, along with patients, look forward to seeing a confirmatory study in the very near future.”
Lea Bentur, MD, Director of the Pediatric Pulmonary Institute at Rambam Health Care Campus and Principal Investigator of the study concluded, “the benefits to the patient are real and meaningful, with an overall benign safety profile. Treating at a higher concentration of nitric oxide for a longer period of time in the patient’s home would be a very significant advancement in the care of these patients.”
Nine cystic fibrosis patients, 5 female and 4 male, infected with MABSC refractory to antibiotic therapy were treated in an open label fashion. Background antibiotic therapy was maintained while 30-minute administrations of 160 ppm NO were performed 5 times per day for 14 days and then 3 times per day for 7 days. The primary endpoint was safety and tolerability. Secondary and other key endpoints were 6-minute walk distance (6MWD), FEV1, mycobacterium abscessus (M. abscessus) load, bacterial load of other relevant pathogens, e.g Pseudomonas aeruginosa (P. aeruginosa) and quality-of-life (QOL). Patients were followed for 60 days post the cessation of therapy.
Table 1. http://www.globenewswire.com/NewsRoom/AttachmentNg/7c8003cc-b000-4492-80ac-a9628b73ae9e
Study Results
For the primary endpoint, there were no Nitric Oxide (NO) related serious adverse events (SAEs). There were two NO-related adverse events (hemoptysis, MetHb) which both resolved quickly with minor to no effect on the patients. Nitrogen dioxide (NO2) levels remained below 2.5 ppm, well below the safety limit of 5 ppm. MetHb levels remained below 7% except for one reading of 7.1% in one patient during one treatment with no negative effects to the patient. All patients completed all treatments in the study.
Figure 1 shows a substantial increase in 6MWD during treatment with the majority of the improvement still maintained at 4 and 8 weeks post treatment cessation.
Figure 2 shows modest improvement in FEV1, rising at day 7, 14 and 21 during treatment. The benefit was gone at day 60 after treatment stoppage.
With respect to M. abscessus load shown in Figure 3, one patient showed complete eradication by culture and 5 of 9 patients showed a >1-log10 reduction in M. abscessus load (qPCR) at week 11.
Four patients were co-infected with chronic, multi-drug resistant P. aeruginosa. At week 11, two patients had negative cultures, one saw a >2-log10 reduction and one had no change in culture.
Figure 1. http://www.globenewswire.com/NewsRoom/AttachmentNg/a09f7e39-f01a-4291-a655-1ab55cee161b
Figure 2. http://www.globenewswire.com/NewsRoom/AttachmentNg/149d205b-e1c1-47ab-ae05-a984d80d985e
Figure 3. http://www.globenewswire.com/NewsRoom/AttachmentNg/3a7ad882-bc7d-4ce9-9210-a8c5f36f411a
About Nitric Oxide (NO)
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 multi-drug resistant strains.
About Mycobacterium abscessus complex (MABSC) of the Lungs
MABSC is the most aggressive and difficult to treat species 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.
About AIT Therapeutics Inc.
AIT Therapeutics Inc. is a clinical-stage medical device and biopharmaceutical company using nitric oxide (NO) to treat patients with respiratory and other diseases. The Company is currently applying its therapeutic expertise to treat patients with lower respiratory tract infections that are not effectively addressed with current standards of care, as well as pulmonary hypertension, in various settings. AIT Therapeutics is currently advancing its revolutionary NO Generator and Delivery System in clinical trials for the treatment of bronchiolitis and patients with severe lung infections such as nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.
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