Draig Therapeutics Highlights Positive Phase 1 DT-101 Results at ASCP Annual Meeting
American Society for Clinical Psychopharmacology served as the stage for new clinical and translational data from Draig Therapeutics, which unveiled encouraging findings from its Phase 1 clinical development program for DT-101, the company’s lead investigational therapy for major depressive disorder (MDD). The presentations underscored the company’s broader mission of developing highly targeted neuropsychiatric therapies designed to precisely modulate the neural circuits associated with mood disorders and other psychiatric conditions.
The company delivered one oral presentation and two scientific poster sessions during the conference, showcasing data that demonstrated favorable safety, tolerability, pharmacokinetics, and evidence of central nervous system target engagement for DT-101. The investigational therapy is an AMPA receptor positive allosteric modulator (PAM), a mechanism increasingly viewed as a promising strategy for rapidly improving depressive symptoms through enhancement of synaptic plasticity.
Draig Therapeutics is advancing a pipeline focused on highly selective modulators of AMPA and GABAA receptors, two critical signaling systems involved in regulating neural communication, cognition, emotional processing, and mood stability. According to the company, these therapies are being engineered to safely and precisely influence neural circuitry while avoiding many of the limitations historically associated with neuropsychiatric drugs.
DT-101 currently represents the company’s most advanced clinical program. The therapy is being investigated for the treatment of major depressive disorder, a condition that continues to affect hundreds of millions of people worldwide and remains one of the largest unmet needs in mental health. Existing antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), often require weeks to show benefit and fail to provide adequate symptom relief for a substantial proportion of patients.
Company executives emphasized that approximately 70 percent of individuals with major depressive disorder do not achieve sufficient response from first-line SSRI therapy, highlighting the urgent demand for innovative treatment approaches capable of delivering faster and more durable outcomes.
The data presented at ASCP came from Draig’s first-in-human Phase 1 clinical trial, a randomized, double-blind, placebo-controlled study conducted in 66 healthy volunteers. Investigators evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of DT-101 across multiple dose levels.
According to the findings shared at the conference, DT-101 demonstrated a favorable safety and tolerability profile throughout the study. Researchers reported that no serious adverse events occurred during the trial, and no participants discontinued treatment because of serious safety concerns. All observed adverse events were characterized as either mild or moderate in severity and resolved without intervention.
Headache emerged as the most frequently reported adverse event, though investigators noted that both the incidence and overall nature of adverse events were generally comparable between the DT-101 treatment groups and placebo recipients. These findings were viewed as particularly encouraging given the historical safety challenges associated with AMPA receptor modulation.
AMPA receptors play a central role in synaptic plasticity, which is the brain’s ability to strengthen or weaken neural connections in response to activity. Synaptic plasticity is believed to be fundamental to learning, memory, emotional adaptation, and mood regulation. Scientists have long viewed AMPA receptor potentiation as a potentially transformative therapeutic mechanism for depression and other neuropsychiatric disorders, especially because of its connection to rapid antidepressant activity.
However, earlier attempts to target AMPA receptors therapeutically have frequently encountered limitations related to narrow therapeutic windows and tolerability concerns. Draig researchers believe DT-101 may overcome some of these historical barriers through its carefully designed pharmacokinetic profile.
One of the key findings highlighted during the ASCP presentations was DT-101’s pulsatile pharmacokinetic profile. Investigators explained that the therapy demonstrated dose-proportional pharmacokinetics while supporting once-daily oral dosing. Importantly, cerebrospinal fluid measurements confirmed that the drug successfully penetrated the central nervous system and reached relevant brain targets.
Researchers noted that DT-101’s transient receptor engagement pattern may be particularly important for promoting synaptic plasticity while reducing the risks associated with sustained AMPA receptor overstimulation. This pulsatile exposure profile is designed to maximize therapeutic benefit by activating the neural mechanisms linked to rapid antidepressant effects without continuously driving receptor activity.
In addition to safety and PK findings, Draig also presented evidence of functional target engagement using magnetoencephalography (MEG), an advanced neuroimaging technology that measures magnetic fields generated by neural activity in the brain. MEG provides highly sensitive temporal and spatial mapping of brain function and is increasingly being explored as a translational biomarker tool in neuroscience research.
The company’s poster presentation titled “Magnetoencephalography (MEG) in a First-In-Human Trial to Demonstrate the Functional Consequences of Target Engagement by DT-101” described what Draig believes is the first Phase 1 clinical study to use MEG for demonstrating functional brain responses to an investigational therapy.
The MEG analyses showed that DT-101 produced measurable and consistent effects on brain function across several experimental paradigms in healthy volunteers. These paradigms were specifically designed to evaluate cortical excitation-inhibition balance, an important neurophysiological process implicated in depression and other psychiatric disorders.
Investigators observed changes in oscillatory brain activity patterns that supported evidence of AMPA receptor target engagement. According to the company, these findings reinforce the hypothesis that AMPA receptor potentiation can effectively modulate excitation-inhibition balance in humans, potentially contributing to rapid and sustained antidepressant effects.
The MEG findings also played a role in informing dose selection decisions for Draig’s ongoing Phase 2 clinical studies in patients with major depressive disorder.
DT-101 is currently being evaluated in multiple Phase 2 clinical programs. These include a global study assessing DT-101 as a monotherapy for major depressive disorder as well as a separate U.S.-based study investigating the therapy as an adjunctive treatment alongside existing antidepressants.
Company leadership framed the ASCP presentations as an important milestone for both the DT-101 program and the broader field of neuropsychiatric drug development.
Ivana Magovčević-Liebisch, PhD, JD, President and Chief Executive Officer of Draig Therapeutics, stated that the company aims to help drive a long-awaited transformation in neuropsychiatric medicine. She emphasized that the company’s development strategy is built upon validated biological targets, decades of neuroscience research, and precision modulation of the major neural circuits underlying psychiatric disease.
She added that the Phase 1 findings provide strong support for Draig’s scientific approach and offer renewed optimism for individuals living with major depressive disorder who continue to struggle with inadequate treatment options.
Simon Ward, PhD, Chief Scientific Officer and Founder of Draig Therapeutics, also highlighted the importance of the findings. He noted that while AMPA receptors are fundamentally linked to synaptic plasticity, learning, and mood regulation, therapeutic development in this area has historically been hindered by safety limitations.
According to Ward, DT-101’s favorable tolerability profile and transient receptor engagement characteristics may represent a significant advancement for AMPA receptor modulation. He further emphasized that the successful use of MEG in the Phase 1 program demonstrates the company’s commitment to leveraging advanced translational neuroscience tools to better understand drug activity in the human brain.
The presentations generated interest among conference attendees as the neuropsychiatry field continues searching for therapies capable of addressing treatment-resistant depression and improving patient outcomes beyond what conventional antidepressants can achieve.
The 2026 ASCP Annual Meeting, held from May 26 through May 29 in Miami Beach, brought together leading researchers, clinicians, and pharmaceutical innovators focused on advancing psychopharmacology and mental health therapeutics. Draig’s presentations added to growing industry momentum surrounding next-generation neuroscience medicines aimed at delivering faster, safer, and more durable therapeutic responses for patients with complex psychiatric disorders.
About DT-101
DT-101 is a Phase 2 AMPAR PAM and the lead program in Draig Therapeutics’ pipeline of highly specific AMPAR & GABAAR modulators designed to enable safe, precise modulation of the major neurocircuits underlying neuropsychiatric disorders. Supported by clinically validated AMPAR biology, DT-101 is an investigational therapy for the potential treatment of major depressive disorder (MDD). It is a next-generation AMPAR PAM with potential best-in-class antidepressant efficacy and speed of onset.
It has demonstrated a clean safety and tolerability profile with excellent CNS distribution and target engagement in Phase 1 development. It is currently being evaluated in TARIAN-1, a global, randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy, safety, and tolerability of DT-101 in people with MDD. DT-101 is also currently being evaluated in AERON-1, a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the effectiveness of DT-101 in an adjunct setting in patients with MDD in the U.S.
About Draig Therapeutics
Draig Therapeutics is a clinical-stage biopharmaceutical company developing transformative, best-in-class neuropsychiatric therapies. Our pipeline of highly specific AMPAR & GABAAR modulators are designed to enable safe, precise modulation of the major neurocircuits underlying neuropsychiatric disorders. Our lead program, DT-101, is a Phase 2 AMPAR PAM with best-in-disease potential in major depressive disorder. Working in partnership with patients and their care partners, Draig is transforming the future of neuropsychiatry.