AIT Therapeutics’ Adjuvant Nitric Oxide Treatment Shown to be Safe and Effective in the Compassionate Use Setting in Cystic Fibrosis Patients with Non-tuberculous Mycobacteria (NTM) Infection
Significant Reductions in Mycobacterium abscessus Load in Sputum Demonstrated
Manuscript Published in the Pediatric Infectious Disease Journal
REHOVOT, Israel and NEW YORK, Sept. 13, 2017 (GLOBE NEWSWIRE) -- AIT Therapeutics Inc. (OTC:AITB), a clinical-stage anti-microbial therapeutic company treating respiratory diseases with nitric oxide (NO), today announced publication of a manuscript of its compassionate use in cystic fibrosis patients with Mycobacterium abscessus complex (MABSC) in the peer-reviewed Pediatric Infectious Disease Journal. MABSC is one of the most antibiotic-resistant pathogens in cystic fibrosis patients, and both patients in the trial showed significant reductions in bacterial load, while also showing the treatment was safe and tolerable.
“We were pleased to see such dramatic results in these two patients with Mycobacterium abscessus complex,” said Steve Lisi, Chief Executive Officer of AIT Therapeutics. “This condition is very difficult to treat and these patients had exhausted all other treatment options. The encouraging results demonstrate our proprietary Nitric Oxide therapy could be a potential treatment for these patients.”
Two cystic fibrosis (CF) patients with MABSC received intermittent inhalations of nitric oxide at 160 parts per million. The treatments were well-tolerated with no safety issues. Both patients showed significant reductions in quantitative PCR results for Mycobacterium abscessus load in sputum during treatment, with the estimated colony forming unit (CFU) decreasing from 7000 to 550 for patient 1 and from 3000 to 0 or complete eradication for patient 2. Study authors recommended further trials be conducted in this patient population. A summary of the abstract can be found here.
Current Ongoing NO Trials
The Company is currently conducting two trials in Nitric Oxide: a Phase 3 study in infants hospitalized due to bronchiolitis and a Phase 2 study in NTM abscessus. The prospective, randomized, double-blind, controlled Phase 3 Nitric Oxide in Bronchiolitis (NO-BRO) trial will compare the company’s proprietary nitric oxide therapy plus current standard-of-care versus the current standard-of-care alone in 94 patients, aged 0-12 months, who are hospitalized due to bronchiolitis. Patients will receive 160 parts per million (ppm) NO treatment five times a day for up to 5 days. The primary endpoint will be hospital length-of-stay (LOS). Secondary endpoints are time required to achieve a clinical score of 5 or less on the modified Tal score and time required to achieve oxygen saturation (SaO2) of 92% or greater. Data from this trial are expected in the first half of 2018.
The single-arm, open-label Phase 2 Nitric Oxide in NTM abscessus (NO-NTM abscessus) trial will enroll 10 patients with MABSC, who are refractory to standard-of-care. Patients will be treated with inhaled NO at a concentration of 160 ppm for 30-minutes, in addition to treatment with standard-of-care. The inhaled NO treatment will be administered intermittently 5 times per day over a 14-day period, followed by a 7-day period with 3 treatments per day. The primary endpoint will be safety, as measured by NO-related serious adverse events (SAEs), over the 21-day treatment period. Secondary endpoints include a 6-minute walk test and Mycobacterium abscessus load in sputum. Data are expected to be announced in the fourth quarter of 2017.
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 anti-microbial therapeutic 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 are not effectively addressed with current standards of care. AIT Therapeutics is advancing its revolutionary respiratory targeted system in clinical trials for the treatment of bronchiolitis (RSV) exacerbations, 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 September 13, 2017