In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment, as a qualified drug development tool.

In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment (AI-COA), as a qualified drug development tool.

A partnership between Gate Neurosciences Inc. and Beacon Biosignals Inc. promises to advance the field of precision psychiatry by using electroencephalogram (EEG) biomarkers to diagnose depression and rapidly assess response to medications. The collaboration will first use Beacon’s U.S. FDA-cleared Dreem 3S headband device and neurobiomarker platform to conduct EEGs in participants in Gate’s phase II trial of zelquistinel, a small-molecule NMDA receptor modulator under development as an antidepressant.

Despite the approval of dozens of antidepression medications, an estimated 30% of individuals who experience major depressive disorder (MDD) fail to respond to treatment despite repeated trials. As about one in eight individuals will experience MDD in their lifetime, investors and researchers have leapt into the gap to find and fund better ways to match treatment to patients, develop non-pharmacological therapies and improve outcomes.

Although esketamine, the S-isomer of ketamine, has been approved for treatment-resistant depression, limitations such as dissociative and sedative effects or poor oral bioavailability restrict its use to parenteral dosing and supervised administration.

After flying high in 2022, digital therapeutics (DTx) companies crashed to Earth in 2023 and scrambled to identify a path to profitability, or at least continued viability.

Enveric Biosciences Inc. has named EB-003 as its lead drug candidate from the company’s next-generation EVM301 series. EB-003 was selected based on data analyses suggesting the molecule’s potential to be a first-in-class approach to addressing difficult-to-treat mental health disorders by promoting neuroplasticity without inducing hallucinations.

Researchers from Engrail Therapeutics Inc. presented preclinical data for the novel D2/3 receptor antagonist ENX-104, being developed for the treatment of depression.

Psychiatric indications, such as depression, schizophrenia and bipolar disorder, share a common feature of elevated expression of pro-inflammatory markers in the periphery and/or central nervous system. Based on this, it is believed that combined immuno- and neuromodulatory activities of phosphodiesterase 4 (PDE4) inhibitors may represent a promising new therapeutic strategy for various psychiatric indications.