Beyond Air, Inc. (XAIR) Announces Publication of Positive New Preclinical Data for the Treatment of Autism Spectrum Disorder

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.”

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