(MENAFN- GlobeNewsWire - Nasdaq) Hebrew University's preclinical results recently published in Advanced Science show a reversal of the molecular, synaptic and behavioral autism spectrum disorder (ASD) phenotypes
Plan to initiate a first-in-human clinical trial of nNOS for treatment of ASD in 2025
Conference call at 4:30 PM ET today, June 15, 2023
GARDEN CITY, N.Y., June 15, 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.), today announced that it has entered into an agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. to license the commercial rights for multiple neuronal nitric oxide synthase (nNOS) inhibitor candidates, currently being developed for the treatment of autism spectrum disorder (ASD) and other neurological conditions. There are currently no therapies approved by the U.S. Food and Drug Administration (FDA) specifically for the treatment of ASD.
“We are the world's leading developer of nitric oxide based therapies, as evidenced by FDA approval of our LungFit PH to treat term and near-term neonates with hypoxic respiratory failure (“persistent pulmonary hypertension of the newborn” or“PPHN”), our robust pipeline of revolutionary LungFit systems in clinical trials for the treatment of various severe lung infections using inhaled NO, the development of ultra-high concentration NO to treat solid tumors through Beyond Cancer, and now the development of nNOS inhibitors to treat autism,” stated Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.“The results of groundbreaking preclinical studies conducted by Dr. Haitham Amal of the Hebrew University suggest a direct link between NO and ASD, which may lead to the first therapy to reverse ASD behavioral deficits. We are pleased to have entered into this partnership and look forward to initiating a planned first-in-human study in 2025.”
“This is an exciting novel approach to treating ASD. The partial inhibition of nNOS reduces nitrosative stress biomarkers and reverses the molecular, synaptic and behavioral ASD-associated phenotypes. Confirming these results in humans should be expedited,” commented Dr. Amal.
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 neuropharmacology in the Faculty of Medicine. His PhD was conducted at the Technion Institute of Technology in Israel. 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. Dr. Amal's research has been widely published, with more than 30 publications on cancer, autism, Alzheimer's disease, and other brain disorders; he has been the recipient of many awards including from the Wolf Foundation. Dr. Amal is a member of many local and international scientific committees and societies.
Under the terms of the agreement, Beyond Air will pay the Hebrew University of Jerusalem, LTD. fees associated with certain pre-clinical, clinical, regulatory and sales milestones. Additionally, the Company will pay a low single digit royalty on net sales.
At normal physiological levels, NO production and degradation are balanced and involved in normal cell signaling and in 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 dysregulation of nNOS may be responsible for various neurodevelopmental, neuropsychiatric, and neurodegenerative disorders including ASD.
Dr. Haitham Amal's lab at the Hebrew University of Jerusalem conducted multidisciplinary comprehensive experiments using cellular and mouse models, as well as clinical samples and human induced pluripotent stem cells (iPSCs) to investigate the role of NO in ASD. To establish if NO leads to biochemical and cellular ASD-like phenotypes, C57BL/6J wild-type (WT) male mice were treated with an NO donor, S-nitroso-N-acetyl penicillamine (SNAP). The study demonstrated, biochemically and behaviorally, that treating WT mice with a NO donor led to an ASD-like phenotype. To determine the involvement of NO in ASD, the study inhibited NO production pharmacologically in the Shank3 mouse (M1) model. For this purpose, M1 mice were treated with a nNOS inhibitor, 7-nitroindazole (7-NI). The Cntnap2(-/-) mutant mouse (M2) model was also used. Like the M1 model, the M2 mice were treated with 7-NI. The results showed that pharmacological intervention with a neuronal NO synthase inhibitor in both models led to a reversal of the molecular, synaptic, and behavioral ASD-associated phenotypes.
Additionally, the study showed that treating human iPSC-derived cortical neurons from patients with SHANK3 mutations with the nNOS inhibitor showed similar therapeutic effects.
This innovative work suggests that NO may play a significant role in ASD development and suggests a novel strategy for an effective treatment. These important findings have unlocked a new pathway to examine NO in diverse mutations on the spectrum, as well as in other neurodevelopmental disorders and psychiatric diseases.
The pre-clinical research, funded by HUJI, was published in Advance Science on May 22, 2023 and can be found here .
Conference Call & Webcast
Company management will host a conference call and webcast at 4:30 p.m. ET today, June 15, 2023, to discuss today's announcement. To access the call, please dial:
US: 1-877-407-0784 Int'l: 1-201-689-8560 Israel Toll Free: 1 809 406 247
Conference ID number: 13739448
Call Me:
Participants can use Guest dial-in #s above and be answered by an operator OR click the Call meTM link for instant telephone access to the event. Call meTM link will be made active 15 minutes prior to scheduled start time.
To access the live audio webcast , please click here , or go to the Events section of Beyond Air's website at . A replay will be available on the Company's website shortly after the conclusion of the event for approximately 90 days.
About the Hebrew University of Jerusalem
The Hebrew University of Jerusalem is Israel's leading academic and research institution. Serving some 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. In 2022 Hebrew University was ranked at number 77 in the 2022 Academic Ranking of World Universities by Shanghai Ranking, making it the leading Israeli university in the world. 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 .
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 11,000 patents globally; licensed over 1,140 technologies and has spun out more than 200 companies. Yissum's business partners span the globe and include companies such as Boston Scientific, ICL, Intel, Johnson & Johnson, Merck, Novartis and many more.