Presentations highlighted the direct killing effect of NO on Mycobacterium abscessus (M. abscessus) and Pseudomonas
aeruginosa (P. aeruginosa) as well as the use of the NO generator and delivery system as a potential therapy for M. abscessus
complex (MABSC) lung infection
GARDEN CITY, N.Y., and REHOVOT, Israel, July 16, 2018 (GLOBE NEWSWIRE) -- AIT Therapeutics, Inc.
(OTC: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
that in-vitro data, as well as data from its compassionate use study, were presented at the 3rd Annual World
Bronchiectasis Conference held at Georgetown University in Washington, D.C. on July 12-14, 2018.
The first poster, entitled: “High-Dose Inhaled Nitric Oxide as a Potential Therapy Against Mycobacterium
abscessus Lung Infection in Cystic Fibrosis,” shows an in vitro dose response for NO in the killing of M.
abscessuss as a monotherapy in sputum. It also demonstrates differences in minimal bactericidal concentration
of NO between various clinical strains of M. abscessus in vitro. The results also revealed the susceptibility of P.
aeruginosa to NO is significantly greater with killing time less than half of what is seen with M.
abscessus, and at a lower concentration.
The second poster, entitled: “Treatment of Refractory Mycobacterium abscessus Lung Infection with Inhaled
Intermittent Nitric Oxide,” demonstrates inhaled NO dosed at 160 parts per million (ppm) for 30 minutes five times per day for
14 days and three times per day for 7 days provided clinical improvement on multiple parameters including 6-minute walk distance,
FEV1 and quality-of-life parameters that persisted for up to 90 days post cessation of therapy. There was no effect on
bacterial load. This patient had underlying cystic fibrosis and the MABSC had persisted for more than 8 years.
Both posters can be accessed on the company website at www.AIT-PHARM.com.
“Results from the treatment with our NO generator and delivery system were consistent with the results shown
from our recently completed nine patient NTM study using cylinder gas,” said Steven Lisi, Chairman and Chief Executive Officer of
AIT Therapeutics. “We continue to be on track to begin a pivotal study by the end of 2019 in nontuberculous mycobacteria (NTM)
pending appropriate funding and anticipate this study will be conducted substantially in the home setting. Our in vitro data
suggest that NO not only kills M. abscessus, but it more easily kills P. aeruginosa which is more prevalent and
with well-established pathogenicity.”
Andrew Colin, M.D., Director, Division of Pediatric Pulmonology at the University of Miami, stated,
“Confirmation of the killing effect of nitric oxide in-vitro on M. abscessus is uplifting. Add in the killing of
Pseudomonas aeruginosa, a notoriously harmful pathogen in our CF population, and one can begin to have hope that NO may be
the non-antibiotic anti-microbial we have been waiting for. The NTM community anxiously awaits the next step in the process
with the NO generator and delivery system”.
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 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 the 3rd Annual Bronchiectasis Conference
The Conference is a focused, cutting-edge gathering of the world’s experts on bronchiectasis and nontuberculous
mycobacterial lung infections. Highlights of the conference include presentations of the most up to date research on disease
mechanisms in bronchiectasis, including new understandings on the role of inflammation, infection and the microbiome.
Clinical topics will include sessions on the diagnosis and treatment of bronchiectasis and NTM infections, including small group,
case-based presentations specifically aimed at understanding the role of airway clearance, anti-inflammatory treatments and
antibiotics.
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 Therapeutics 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) 597-698
