Atai Launches Phase 1 Clinical Trial On Novel Direct-To-Brain Drug Delivery Technology

Clinical stage biopharma company atai Life Sciences ATAI 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, with topline results expected in the first half of 2023. 

The two-stage, open-label, randomized study will assess the safety, tolerability and effective direct-to-brain delivery of INB-01 through the aptar nasal drug delivery device. 

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.

atai’s INB-01 technology would deliver drugs as a liquid at room temperature, which becomes a gel when introduced into the nose. It has already been utilized with both water-soluble and insoluble compounds and extracts with successful results.  Preclinical studies have shown positive results in the dosing of INB-01 when measuring drug levels in the brain as well as through MRI imaging. 

atai’s co-founder and CEO Florian Brand believes that exploring the drug delivery mechanism constitutes an opportunity to further enhance the treatment experience, as INB01 would provide a “superior drug uptake” by reducing dose administered and frequency. 

“We are confident this will help patients and healthcare practitioners by easing administration, dosing, and providing faster relief to improve compliance,” Brand concluded. 

Dr. Majed Fawaz, atai’s vice president of Chemistry, Manufacturing & Controls, added that INB-01’s novel direct-to-brain delivery technology would support the lifecycle of the company’s drug development pipeline. 

"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," said Fawaz.

Photo courtesy of Colin Behrens on Pixabay.