Atai Life Sciences announced that it has initiated a Phase 1 proof-of-concept trial of its INB-01, an excipient designed to cause gelling of liquid nasal sprays when the aerosol deposits in the nasal cavity. In July 2021, Atai said that it was launching a company called Innaris Bio to develop the sol-gel technology for use in intranasal CNS drug formulations in partnership with University of Queensland technology transfer company UniQuest.
According to Atai Life Sciences, the open-label study will compare an INB-01 formulation to placebo, with topline results anticipated in the first half of 2023. The clinical trial formulations will be delivered via an Aptar Pharma nasal delivery device.
Atai Life Sciences CEO Florian Brand said, “Exploring the mechanism of drug delivery is an opportunity for us to further enhance the treatment experience. 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.”
VP of Chemistry, Manufacturing & Controls Majed Fawaz 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.”
Read the Atai Life Sciences press release.
