AIT Therapeutics Announces Study Published in Journal of Cystic Fibrosis
GARDEN CITY, N.Y. and REHOVOT, Israel, May 29, 2019 (GLOBE NEWSWIRE) -- AIT Therapeutics, Inc. (NASDAQ: 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 the study, authored by Professor Lea Bentur, Director, Pediatric Pulmonary Institute, Rambam Medical Center, Haifa Israel, entitled, “Pilot study to test inhaled nitric oxide in cystic fibrosis patients with refractory Mycobacterium abscessus lung infection,” was published in the Journal of Cystic Fibrosis.
“We achieved our goal of demonstrating the safety and tolerability of inhaled nitric oxide in cystic fibrosis patients with Mycobacterium abscessus lung infection and determined that further evaluation is warranted given the improvement shown in mean lung function, quality of life, physical function and M. abscessus load as shown by a downward trend in the sputum M. abscessus load measured during the study,” said Dr. Lea Bentur. “The study was not powered to demonstrate statistical significance, but we believe intermittent NO at 160ppm has the potential to demonstrate meaningful benefits to patients with cystic fibrosis where currently M. abscessus is an incurable chronic infection in most CF patients.”
The open-label pilot study assessed the safety and efficacy of intermittent inhaled NO (iNO) as an adjuvant therapy to antibiotics in nine cystic fibrosis patients with refractory M. abscessus lung infection. Subjects received 160ppm iNO five times per day during hospitalization (14 days), and three times per day during ambulatory treatment (7 days) for a total of 21 days of treatment. The primary outcome of safety was measured by NO-related Serious Adverse Events (SAEs); secondary outcomes were six-minute walk distance (6MWD), forced expiratory volume in 1 second (FEV1), and M. abscessus burden in airways. Results showed iNO was well-tolerated and no iNO-related SAEs were observed during the study. Mean FEV1 and 6WMD increased relative to baseline during NO treatment. M. abscessus culture conversion was not achieved, but three of the nine patients experienced at least one negative culture during the study. Mean time to positivity in M. abscessus culture, and qPCR analysis showed reductions in sputum bacterial load. The study was not powered to achieve statistical significance in FEV1, 6WMD, or bacterial load.
“We are encouraged by the findings of this study and pleased to see the meaningful improvements in these patients,” said Steven Lisi, Chairman and CEO of AIT. “We believe our Nitric Oxide Generator and Delivery system could become an important treatment option for these patients as it may allow for a longer duration of treatment with patients self-administering at home.”
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 targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including 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 NO Generator and Delivery System*
AIT’s NO Generator and Delivery System is a cylinder-free, phasic flow nitric oxide delivery system and has been designated as a medical device by the US Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm. The NO Generator and Delivery system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. The system can also deliver NO at concentrations above 80 ppm for which intended treatments are: bronchiolitis in the hospital setting, and chronic, refractory lung infections in the home setting. For the first time, AIT intends to offer NO treatment in the home setting with the elimination of cylinders.
* AIT’s NO Generator and Delivery System is not approved for commercial use and the AIT is not suggesting use over 80 ppm or use at home. AIT’s NO Generator and Delivery System is for investigational purposes only.
Nontuberculous mycobacteria (NTM) is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated with increased morbidity and mortality. NTM infection is acquired by breathing in aerosolized bacteria from the environment, and if ignored can lead to NTM lung disease, a progressive and chronic condition. NTM is an emerging public health concern worldwide because of its multi-drug antibiotic resistance. Current treatment guidelines suggest a combination of multiple antibiotics delivered continually for as long as two years. These complex, expensive and invasive regimens have a poor record in the treatment of Mycobacterium abscessus complex (MABSC) and refractory Mycobacterium avium complex (MAC) and have the potential for causing severe adverse events. AIT’s system is designed to effectively deliver 160 - 400 ppm NO to the lung, and early data indicate that this range of NO concentration may have a positive effect on patients infected with NTM.
About AIT Therapeutics Inc.
AIT Therapeutics Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System that uses NO generated from ambient air and delivers precise amounts of NO to the lungs for the potential treatment of respiratory and other diseases. The AIT NO Delivery System can generate up to 400 ppm of NO for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for lower respiratory tract infections that are not effectively addressed with current standards of care. 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.
The AIT NO Generator and Delivery System is not approved by any regulatory agency and is in the development stage.
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
Released May 29, 2019