GARDEN CITY, N.Y. and REHOVOT, Israel, Sept. 19, 2018 (GLOBE NEWSWIRE) -- AIT Therapeutics, Inc. (OTCQB: AITB), 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, today announced two poster presentations on inhaled NO at the European Respiratory Society (ERS) International Congress 2018, being held September 15-19 in Paris, France.

Data were presented from the Company’s multicenter, randomized, double-blind, placebo controlled study comparing the efficacy of intermittent 160 ppm NO (five 30-minute treatments per day for up to 5 days) plus standard of care (SOC) (typically oxygen and hydration) against SOC alone.  The study evaluated 67 infants diagnosed with bronchiolitis and admitted to 6 hospitals across Israel.

The primary endpoint of the study was hospital Length-Of-Stay (LOS) as measured from the time of enrollment to the time of hospital discharge.  Secondary endpoints were time to a composite (mTal) score <5 (mTal score ranges from 0-12, patient score at enrollment was 7-10) and time to SaO₂ >92% (SaO₂ describes the amount of oxygen bound to hemoglobin in arterial blood).

With respect to the primary endpoint, the mean LOS was reduced by 23.0 hours for the patients treated with NO + SOC versus SOC alone (59.2 vs. 82.2 hours, respectively, p=0.085: Welch’s t-test). For the secondary endpoints, the time to SaO2 >92% was reduced by 18.2 hours (42.6 vs. 60.8, p=0.053) and time to mTal score <5 improved by 12.1 hours (39.6 vs. 51.7, p=0.20).  There we no serious adverse events associated with NO therapy.

“We are pleased to present the complete dataset from our NO-BRO study showing an impressive 23-hour reduction in hospital length of stay with an excellent safety profile as well as favorable results on the secondary endpoints,” said Steven Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “We look forward to initiating a pivotal trial in the fourth quarter of calendar year 2019 with a premarket approval (PMA) submission to FDA anticipated to take place in the second half of 2020.  In addition, we presented in vitro data that further demonstrates the potential of nitric oxide as a monotherapy to treat Mycobacterium abscessus lung infection, the most aggressive and difficult to treat species of non-tuberculous mycobacteria (NTM).”

The results of high-dose nitric oxide as an antibacterial agent in the treatment of Mycobacterium abscessus complex (MABSC) were presented.  The Company investigated several multidrug-resistant clinical isolates of M. abscessus to determine sensitivity to NO, which was delivered using a custom designed NO delivery system at specific concentrations. M. abscessus was cultured in artificial sputum, to mimic sputum of cystic fibrosis patients, and treated with humidified medical air or high-dose NO (160-400ppm) for up to 10 hours.  The results show significant dose-dependent antibacterial activity of high dose NO against several multi-drug resistant clinical isolates of M. abscessus.

Both posters are available on the AIT website. 

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 Bronchiolitis
The majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV).  RSV is a common and highly transmissible virus that infects the respiratory tract of most children before their second birthday.  While most infants with RSV present with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening.  The absence of treatment options for bronchiolitis limits the care of these sick infants to largely supportive measures.  AIT’s system is designed to effectively deliver 160 ppm NO, which has been proven to eliminate bacteria, viruses, fungi and other microbes from the lungs.

About Mycobacterium abscessus complex (MABSC) of the Lungs
MABSC is the most aggressive and difficult to treat species of nontuberculous 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 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 is currently advancing its revolutionary NO Generator and Delivery System in clinical trials for the treatment of bronchiolitis and severe lung infections such as 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