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

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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 .  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 . 

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 load in sputum. Data are expected to be announced in the fourth quarter of 2017.

Bob Yedid LifeSci Advisors, LLC (646) 597 6989


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Globe Newswire: 13:30 GMT Wednesday 13th September 2017

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