GARDEN CITY, N.Y. and REHOVOT, Israel, Oct. 16, 2019 — Beyond Air, Inc. (NASDAQ: XAIR), 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 successful completion of a 30-day rat toxicology study and provided an update on its 12-week toxicology studies in both rats and dogs. All administrations in the studies were done with LungFit™, the company’s proprietary cylinder-free, phasic flow NO generator and delivery system.
In both the 30-day rat study and the 12-week rat and dog studies, animals were dosed intermittently, multiple times per day with animals in the 30-day study receiving NO doses of up to 400 ppm. Results from the 30-day study demonstrated clean safety results with no unexpected findings. The 12-week rat study completed earlier this month, and the 12-week dog study is in week 8 with animals receiving NO doses of up to 250 ppm.
“These data clearly demonstrate the safety of high concentration NO dosed intermittently and are consistent with the safety seen to date in more than 85 human subjects treated with NO at concentrations of 160 ppm to 250 ppm,” said Steve Lisi, CEO of Beyond Air. “We look forward to using these data to support our pivotal bronchiolitis study planned for the 2020/21 winter in the United States and our 12-week nontuberculous mycobacteria study where patients will self-administer NO at home.”
The 30-day rat study was a 4-arm study (150 ppm, 250 ppm, 400 ppm and control) examining NO dosed intermittently, multiple times per day. All animals survived through the scheduled termination of the study. Histopathological examination revealed no evidence of NO-related macroscopic or microscopic findings. Nitrogen dioxide (NO2) approximate mean level was 6.5 ppm at the 400 ppm NO dose, with a maximum level of 10 ppm during administration. Methemoglobin (MetHb) levels increased during NO administration as anticipated. However, all MetHb levels returned to baseline/normal range prior to the next NO administration.
The 12-week rat and dog studies are both 2-arm studies (250 ppm and control) examining NO dosed intermittently, multiple times per day. The studies were designed to mimic the intended treatment regimen for NTM patients with the LungFit™ NTM system. Dosing in the rat study was completed on October 1, 2019, with all animals surviving through the scheduled termination of the study. Dosing in the dog study is ongoing and is presently in week 8, with no mortality and all animals tolerating treatment.
Beyond Air’s LungFit™ 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 U.S. Food and Drug Administration. 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 LungFit™ 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 LungFit™ 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, Beyond Air intends to offer NO treatment in the home setting with the elimination of cylinders.
** Beyond Air’s LungFit™ is not approved for commercial use and Beyond Air is not suggesting use over 80 ppm or use at home. The LungFit™ is for investigational purposes only.
About Nitric Oxide (NO)
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.
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. Beyond Air’s system is designed to effectively deliver over 80 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi and other microbes from the lungs.
About Nontuberculous Mycobacteria or NTM
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. Beyond Air’s LungFit™ NTM system is designed to effectively deliver up to 400 ppm NO to the lung, and early data indicate that concentrations of 160 ppm and higher, intermittent inhaled NO may have a positive effect on patients infected with NTM.
About Beyond Air, Inc.
Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System (LungFit™) 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 LungFit 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. Beyond Air 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.beyondair.net.
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
Beyond Air, Inc.
LifeSci Advisors, LLC