Beyond Air® Announces Publication of Positive New Preclinical Data for the Treatment of Autism Spectrum Disorder

New data demonstrates a therapeutic effect for at least 10 days after a single subcutaneously (SC) injection of an extended-release selective neuronal nitric oxide synthase (nNOS) inhibitor

The slow-release formulation led to reversal of behavioral phenotypes and the nitrosative stress of the Shank3 mouse model of autism.

GARDEN CITY, N.Y., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”) a commercial stage medical device and biopharmaceutical company focused on harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. (“Beyond Cancer”)), today announced the publication of new data that support ongoing preclinical development of selective nNOS inhibitors for the treatment of Autism Spectrum Disorder (ASD).

The Hebrew University of Jerusalem (HUJI) has previously published studies suggesting that NO is a pathologic factor in ASD. In previously published studies, 10-day daily injections of 7-nitroindazole (7-NI), a selective nNOS inhibitor, reversed the manifestations of ASD phenotype, and reversed nitrosative stress. These new data published by HUJI, available online at ScienceDirect (Effects of extended-release 7-nitroindazole gel formulation treatment on the behavior of Shank3 mouse model of autism - ScienceDirect), provide additional evidence for the efficacy of selective nNOS inhibitors in the treatment of ASD. The novel extended-release gel formulation maintained the plasma level of 7-NI at ~45 μg/ml/day for approximately 10 days. The researchers observed improved cognitive memory, social interaction and reduced anxiety-like behavior in Shank3 mutant mice. This was accompanied by a reduction in 3-nitrotyrosine levels (an indicator of nitrative/nitrosative stress).

Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, stated, “These new data from HUJI reinforce previously published efficacy data, and provide strong evidence to suggest a convenient dosing regimen for patients. We are pleased to have such a dedicated partner in HUJI and look forward to advancing this program as quickly as possible.”

The collaboration between Beyond Air and HUJI to develop selective nNOS inhibitors for the treatment of ASD is being conducted under a research and license agreement signed via Yissum, Research Development Company of the Hebrew University.

“These novel data provide new evidence of the role of nitric oxide in autism. It further proves the efficacy of the nNOS inhibitors for ASD treatment. The novel sustained release strategy will open the door for the feasibility of such a treatment,” stated Prof. Haitham Amal, B.Sc.Pharm, Ph.D., Assistant Professor at the School of Pharmacy, Faculty of Medicine at the Hebrew University. “We are eager to reach our ultimate goal of developing therapeutics for ASD.”

About the Hebrew University of Jerusalem (HUJI)

The Hebrew University of Jerusalem is Israel's leading academic and research institution. Serving 24,000 students from 80 countries, it produces a third of Israel's civilian research and is ranked 12th worldwide in biotechnology patent filings and commercial development. Faculty and alumni of the Hebrew University have won eight Nobel Prizes and a Fields Medal. For more information about the Hebrew University, please visit http://new.huji.ac.il/en.

Dr. Amal is an Assistant Professor at the Institute for Drug Research, Faculty of Medicine at the Hebrew University of Jerusalem. He began his academic journey at the age of seventeen, with a degree in Pharmacy, from the Hebrew University. From there he moved to Tel Aviv University for his master’s degree in the Faculty of Medicine. Dr. Amal started his work on ASD and Alzheimer’s disease at MIT in 2015. At MIT, the first paper of his postdoctoral research was published in the Journal of Molecular Psychiatry – the leading journal in Psychiatry. It represented the first literature to link nitric oxide with autism spectrum disorder, a key step towards identifying a drug target for the disorder. Dr. Amal’s research has been widely published, with more than 23 papers on cancer, autism, Alzheimer’s disease, and other brain disorders; he has been the recipient of many awards. Dr. Amal is a member of many local and international scientific committees and societies. 

About Yissum
Yissum is the technology transfer company of the Hebrew University of Jerusalem. Founded in 1964, it serves as a bridge between cutting-edge academic research and a global community of entrepreneurs, investors, and industry. Yissum’s mission is to benefit society by converting extraordinary innovations and transformational technologies into commercial solutions that address our most urgent global challenges. Yissum has registered over 11,500 patents globally, licensed over 1,140 technologies and has spun out more than 245 companies. Yissum’s business partners span the globe and include companies such as Boston Scientific, ICL, Merck and many more. For further information please visit www.yissum.co.il.

About Autism Spectrum Disorder (ASD)
ASD is a serious neurodevelopmental and behavioral disorder, and one of the most disabling conditions and chronic illnesses in children. ASDs include a wide range of developmental disorders that share a core of neurobehavioral deficits manifested by abnormalities in social interactions, deficits in communication, restricted interests, and repetitive behaviors. In 2023, the CDC reported that approximately 1 in 36 children in the U.S. is diagnosed with an ASD. On average, ASD costs an estimated $60,000 a year through childhood, with the bulk of the costs in special services and lost wages related to increased demands on one or both parents. Mothers of children with ASD, who tend to serve as the child’s case manager and advocate, are less likely to work outside the home. On average, they work fewer hours per week and earn 56 percent less than mothers of children with no health limitations and 35 percent less than mothers of children with other disabilities or disorders. The cost of caring for Americans with autism had reached $268 billion in 2015 and would rise to $461 billion by 2025 in the absence of more-effective interventions and support across the life span. 

About Beyond Air^®, Inc.
Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors. The Company has received FDA approval for its first system, LungFit^® PH for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM). The Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of Autism Spectrum disorder (ADS) and other neurological disorders. Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.

Forward Looking Statements
This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “appears,” “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “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 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 views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Beyond Air and Beyond Cancer undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.

CONTACTS:

Edward Barger
Head of Investor Relations
ebarger@beyondair.net

Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577