Highlights at European Respiratory Society (ERS) to include updated data from company’s NO-BRO Pilot study of high-dose inhaled nitric oxide (NO) in infants hospitalized with acute bronchiolitis
Additional pre-clinical data at ERS and European Society of Clinical Microbiology and Infectious Diseases/American Society for Microbiology to show potential of inhaled NO against Mycobacterium abscessus complex
GARDEN CITY, N.Y., and REHOVOT, Israel, Sept. 04, 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 that it would present data on inhaled NO at both the European Respiratory Society (ERS) International Congress 2018, being held September 15-19 in Paris, France, and at the joint European Society of Clinical Microbiology and Infectious Diseases and American Society for Microbiology (ESCMID/ASM) Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance, being held September 4-7 in Lisbon, Portugal.
At ERS, the Company will present updated data from its NO-BRO pilot study in infants hospitalized with acute bronchiolitis, as well as data highlighting the potential use of NO as a treatment option for Mycobacterium abscessus complex (MABSC) of the lung. AIT Therapeutics previously reported positive top-line results from its NO-BRO study in June 2018. Based on these data, a pivotal trial is expected to commence in the fourth quarter of calendar year 2019. At ESCMID/ASM, the Company will present pre-clinical data on the potential use of NO as a treatment option in MABSC lung infection.
“We are pleased to have the opportunity to present updated positive data from our NO-BRO pilot trial in infants hospitalized with acute bronchiolitis,” said Steven Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “These data are the basis for our planned pivotal study, which we expect to initiate in the fourth quarter of calendar year 2019. In addition, we will be presenting pre-clinical data that further demonstrates the potential of nitric oxide to treat MABSC, the most aggressive and difficult to treat species of non-tuberculous mycobacteria.”
Details of the poster presentations at both conferences are as follows:
|28th International Congress of the ERS|
|Title:||“A Phase 3 multicenter, randomized, double-blind, controlled trial of high-dose inhaled nitric oxide in infants with acute bronchiolitis”|
|Poster Session:||TP-36: Session 457: PA 4462|
|Author:||Aviv Goldbart (Beer Sheva, Israel)|
|Date/Time:||Tuesday, September 18, 2018: 12:50pm – 2:40pm|
|Title:||“High-dose nitric oxide as a potential new therapeutic agent against Mycobacterium abscessus”|
|Poster Session:||7.2C: Session 558: PA 5463|
|Author:||Abdi Ghaffari (Kingston, Canada)|
|Date/Time:||Wednesday, September 19, 2018: 10:45am – 12:45pm|
|ESCMID/ASM Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance|
|Title:||“High-dose nitric oxide inhibits growth of mycobacterium abscessus”|
|Poster Session:||Category 3: Drug Development; poster # 104|
|Author:||Kristijan Bogdanovski (Bethesda, USA)|
|Date/Time:||September 4-7, 2018|
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.
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.
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.
Steven Lisi, Chief Executive Officer
AIT Therapeutics, Inc.
LifeSci Advisors, LLC