DT-101 demonstrated a favorable safety and tolerability profile in randomized, double-blind, placebo-controlled Phase 1 trial in healthy volunteers

Pharmacokinetics (PK) were dose-proportional with a pulsatile profile, confirmed central nervous system exposure, and support once-daily dosing

First Phase 1 study to use magnetoencephalography (MEG) to demonstrate functional brain responses

Data support MEG as a translational pharmacodynamic biomarker of central target engagement to directly inform dose selection and clinical progression

Draig Therapeutics, a clinical-stage biopharmaceutical company developing transformative, best-in-class neuropsychiatric therapies, presented today an oral presentation and two posters at the American Society for Clinical Psychopharmacology (ASCP) Annual Meeting.

Draig’s pipeline of highly specific AMPA and GABA_A receptor modulators are designed to enable safe, precise modulation of the major neurocircuits underlying neuropsychiatric disorders. The Company’s lead program, DT-101, is an AMPA receptor potentiator (or positive allosteric modulator - PAM) designed to address the unmet needs in major depressive disorder (MDD). Phase 2 studies evaluating the effectiveness of DT-101 in patients with MDD are ongoing including a global study for DT-101 as a monotherapy and a U.S. study for DT-101 in an adjunct setting.

Data presented from the Company’s first-in-human, randomized, double-blind, placebo-controlled Phase 1 trial in healthy volunteers showed that DT-101 demonstrated a favorable safety and tolerability profile. DT-101 also achieved a pulsatile PK in humans to enable transient AMPA receptor engagement critical for driving synaptic plasticity.

Additional data highlight the potential of magnetoencephalography (MEG) as a translational pharmacodynamic biomarker of central target engagement. MEG measures magnetic fields from neural activity with more sensitivity and superior spatial resolution than EEG.

“A paradigm shift in neuropsychiatric drug discovery is long overdue. Currently, about 70 percent of patients with major depressive disorder do not respond to first-line SSRIs. At Draig, our mission is to transform the future of neuropsychiatry and enable patients to live their best lives. Built on validated targets and mechanisms, and backed by decades of learnings, our pipeline of safe and precise modulators of the major neurocircuits underlying neuropsychiatric disorders, including DT-101, are designed to meet this pressing need,” said Ivana Magovčević-Liebisch, PhD, JD, President and Chief Executive Officer of Draig Therapeutics. “The safety and target engagement data presented today provide compelling evidence for Draig’s approach as well as offer renewed hope for patients living with major depressive disorder.”

Key highlights from the oral and poster presentations titled, DT-101 – a Novel alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Receptor (AMPAR) Positive Allosteric Modulator Demonstrates Favorable Tolerability and Functional Biomarkers in Phase 1 Healthy Volunteer Trial, include:

• DT-101 demonstrated a favorable safety and tolerability profile in 66 healthy volunteers, with no serious adverse events (SAEs) or discontinuations due to SAEs.
• All adverse events (AEs) were mild or moderate in severity and self-resolving, with the most common AE being headache.
• Incidence and nature of AEs were comparable to placebo.
• Pharmacokinetics (PK) were dose-proportional and supported once-daily oral dosing, with cerebrospinal fluid (CSF) concentrations, confirming central nervous system exposure. Importantly, DT-101 displayed a pulsatile PK profile which maximizes synaptic plasticity to potentially unlock fast and durable therapeutic effects.
• DT-101 showed consistent evidence of functional target engagement and pharmacological activity based on MEG data which are detailed in the poster presentation described below.

Key highlights from the poster presentation titled, Magnetoencephalography (MEG) in a First-In-Human Trial to Demonstrate the Functional Consequences of Target Engagement by DT-101, a Novel AMPA Receptor Positive Allosteric Modulator, include:

• First Phase 1 clinical study to use MEG to demonstrate functional brain responses to an investigational drug.
• DT-101 produced clear, measurable effects on brain function across multiple MEG paradigms in healthy volunteers.
• Across complementary paradigms probing cortical excitation–inhibition balance, DT-101 demonstrated consistent effects on oscillatory activity, providing evidence of target engagement.
• These findings support AMPAR potentiation as a mechanism to modulate excitation–inhibition balance in humans and helped inform dose selection for Phase 2 clinical development of DT-101 in major depressive disorder.

“AMPA receptors are at the center of synaptic plasticity underlying synaptic strength, learning, and mood-relevant circuitry. However, for too long, the progress of AMPA receptor potentiation has been limited by narrow safety margins. The favorable safety and tolerability profile demonstrated by DT-101 marks a meaningful step forward for this mechanism and signals Draig’s potential to address the unmet needs in major depressive disorder,” said Simon Ward, PhD, Chief Scientific Officer and Founder of Draig. “We’ve seen that DT-101 displays a pulsatile PK profile which enables transient receptor engagement, aligned with synaptic plasticity mechanisms – reinforcing its potential to deliver fast and durable therapeutic effects. As the first Phase 1 clinical study using MEG to demonstrate functional brain responses to an investigational drug, we are confident that DT-101 is on its way to becoming a transformative treatment option for those living with major depressive disorder.”

The ASCP Annual Meeting is the premier meeting in the field of psychopharmacology and is being held May 26 – 29, 2026 in Miami Beach, Florida.

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.

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“The safety and target engagement data presented today provide compelling evidence for Draig’s approach as well as offer renewed hope for patients living with major depressive disorder," said Ivana Magovčević-Liebisch, PhD, JD, President and CEO