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Press Release

AIT Therapeutics Completes Treatment of Patient Infected with NTM abscessus at the National Institute of Health (NIH) with its Nitric Oxide (NO) Treatment


Posted on: 02 Nov 17

No Treatment Related Adverse Events Reported; Key Data Points Trend Positive

NEW YORK, Nov. 02, 2017 (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 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.

Forward-Looking Statement
This press release contains “forward-looking statements.”  Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; and our short operating history. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.

CONTACT
Steven Lisi, Chief Executive Officer
AIT Therapeutics, Inc.
Steve@AIT-Pharm.com

Bob Yedid
LifeSci Advisors, LLC
Bob@LifeSciAdvisors.com
(646) 597-6989

GlobeNewswire
globenewswire.com

Last updated on: 02/11/2017

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