June 22, 2023 — Beyond Air^®, Inc. (NASDAQ: XAIR), a commercial stage medical device and biopharmaceutical company, licensed the commercial rights to develop a treatment for autism spectrum disorder (ASD) and other neurological conditions from Yissum Research Development Company LTD., the technology transfer company of the Hebrew University of Jerusalem (HU). Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically for treating ASD.

“We’re excited about advancing our novel approach for treating ASD, and hope to one day help children and families around the world,” says Dr. Haitham Amal, a professor at the Hebrew University School of Pharmacy, Institute for Drug Research, Faculty of Medicine.

“The results of groundbreaking preclinical studies conducted by Hebrew University researcher Dr. Amal suggest a direct link between Nitric Oxide (NO) and ASD, which may lead to the first therapy to reverse ASD behavioral deficits,” says Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We are pleased to have entered into this partnership and look forward to initiating a planned first-in-human study in 2025.”

The partial inhibition of neuronal nitric oxide synthase enzyme (nNOS) reduces nitrosative stress biomarkers. This reverses observable molecular, synaptic, and behavioral ASD-associated traits, or phenotypes. At normal physiological levels, NO production and degradation are balanced and contribute to normal cell signaling and regulating numerous physiological functions. At higher concentrations, however, NO produced via nNOS becomes toxic and can lead to abnormal cell signaling and cell death. This nNOS dysregulation may be responsible for various neurodevelopmental, neuropsychiatric, and neurodegenerative disorders, including ASD.

The Hebrew University team’s recent paper in Advanced Science details the potential of this ASD treatment. This research was generously funded by the Satell Family Foundation and the Neubauer Family Foundation as well as grants from the Eagles Autism Foundation, the U.S. Department of Defense (DoD), the Israeli Science Foundation (ISF), the National Institute of Psychobiology in Israel (NIPI), the Israeli Council for Higher Education Maof Grant, and the Berettler Centre for Research in Molecular Pharmacology and Therapeutics.

In his Hebrew University Laboratory for Neuromics, Cell Signaling, and Translational Medicine, Dr. Amal leads a group of scientists whose goal is to discover therapeutics and biomarkers for ASD, Alzheimer’s, other brain disorders, and diseases.

Prior to joining Hebrew University, Dr. Amal was a Senior Postdoctoral Fellow at MIT and an affiliate in the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard. In 2015, he received his Ph.D. from the Technion-Israel Institute of Technology in Nanotechnology and Chemical Engineering. Dr. Amal received his M.Sc. in Pharmacology at Tel Aviv University in 2009, and a B.Sc. in Pharmacy from Hebrew University in 2007.