atai Life Sciences Announces Initiation of Phase 1 Proof-of-Concept Clinical Trial for Its Sol-gel Based Direct-to-Brain Drug Delivery Technology
– atai has initiated a Phase 1 proof-of-concept clinical trial to demonstrate the safety, tolerability, and direct-to-brain delivery of intranasal INB-01, a sol-gel based drug-delivery technology.
– INB-01 may enable direct-to-brain delivery of various compounds in development across atai’s pipeline, with topline results expected in H1 2023.
– Potential advantages may include ease of administration, increased patient compliance, lower dose requirements, rapid onset of action, and minimized systemic exposure.
NEW YORK and BERLIN, Oct. 18, 2022 (GLOBE NEWSWIRE) -- atai Life Sciences (“atai” or the “Company”) (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders today announced the initiation of the Phase 1 proof-of-concept (PoC) clinical trial of intranasal INB-01, a sol-gel based, excipient (drug-delivery) technology.
This is a Phase 1 two-stage, open-label, randomized study of the safety, tolerability, and effective brain delivery of INB-01. INB-01 or placebo will be administered to subjects using the Aptar Nasal Drug Delivery Device. Topline results are expected in H1 2023.
Traditional oral or intravenous drug delivery methods can be problematic in the treatment of central nervous system (CNS) disorders. When drugs are delivered via these peripheral methods, the blood–brain barrier restricts the entry of therapeutic agents to the CNS, thereby decreasing drug efficacy.
A potential solution is direct-to-brain delivery through the nose. This method has the potential to be a non-invasive administration route and may offer additional advantages such as ease of administration, increased patient compliance, lower dose requirements, rapid onset of action, and minimized systemic exposure, which may reduce the risk of peripheral toxicity.
Our INB-01 technology is designed to deliver pharmaceutical compounds as a liquid at room temperature, which becomes a gel instantaneously in the nasal cavity. The novel technology has been successfully utilized with both water-soluble and insoluble compounds and extracts. Prior to launching this PoC trial in humans, dosing of INB-01 has shown positive results in animals when measuring levels of INB-01 in the brain as well as MRI imaging of the brain. These results are a promising predictor for the use of INB-01 in human subjects for intranasal direct-to-brain drug delivery.
“Exploring the mechanism of drug delivery is an opportunity for us to further enhance the treatment experience,” said Florian Brand, Co-Founder, and CEO of atai Life Sciences. “INB-01 has the potential to provide superior drug uptake via the nose-brain barrier, reducing dose administered and dosing frequency. We are confident this will help patients and healthcare practitioners by easing administration, dosing, and providing faster relief to improve compliance.”
Dr. Majed Fawaz, Vice President, Chemistry, Manufacturing & Controls at atai, further commented, “INB-01 offers a novel direct-to-brain delivery technology that will support the lifecycle of atai’s drug development pipeline. We are thrilled to commence the Phase 1 proof-of-concept trial for INB-01. This is the first important step in understanding the safety, tolerability, and brain delivery potential of INB-01 in healthy adult subjects prior to pairing it with active pharmaceutical ingredients.”
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai's vision is to heal mental health disorders so that everyone, everywhere, can live a more fulfilled life. For more information, please visit www.atai.life
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: statements regarding the trials by InnarisBio and future activities thereunder, the potential of INB-01, the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements.
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