The patient, who has cystic fibrosis, was diagnosed with M. abscessus more than 5 years ago.
No Treatment Related Adverse Events Reported; Key Data Points Trend Positive
NEW YORK, Nov. 02, 2017 (GLOBE NEWSWIRE) -- AIT Therapeutics (OTC:AITB), a clinical-stage biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions including serious lung infections and pulmonary hypertension, today announced that intramural investigators in the National Heart, Lung and Blood Institute (NHLBI) have completed treatment with the AIT Nitric Oxide generator system of one patient with treatment-refractory Mycobacterium abscessus (M. abscessus) lung disease at the NIH Clinical Center under the FDA compassionate use program.
The patient, who has cystic fibrosis, was diagnosed with M. abscessus more than 5 years ago and has had progressive deterioration of lung disease consistent with M. abscessus infection despite treatment with more than a dozen antibiotics in various combinations. Toxicities developed from these treatments include peripheral neuropathy, hearing loss and dystonic-type reactions.
Background treatment at the time of treatment with NO was avibactam/ceftazidime + ceftaroline, tigecyclene and bedaquiline. NO treatment of 160 ppm was delivered for 30 minutes 5 times per day over the first 14 days followed by 3 times per day for 7 days was added to her background regimen.
There were no NO related serious adverse events reported over the 21-day treatment period. Key parameters such as FEV1 and 6-minute walk showed improvement. The patient reported improvement in several quality-of-life measures. The M. abscessus bacteria was not eradicated. The patient has requested to be re-treated and AIT will seek the appropriate approvals to do so.
“We are encouraged by the positive outcomes in key parameters and the lack of adverse events,” commented Steve Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “We look forward to continuing our work towards improving the lives of patients with M. abscessus.”
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 as well as pulmonary hypertension in various settings. AIT Therapeutics is currently 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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CONTACT
Steven Lisi, Chief Executive Officer
AIT Therapeutics, Inc.
Steve@AIT-Pharm.com
Bob Yedid
LifeSci Advisors, LLC
Bob@LifeSciAdvisors.com
(646) 597-6989
