Autobahn Therapeutics, a clinical-stage biotechnology company advancing restorative therapies for individuals living with neuropsychiatric and neuroimmunologic disorders, today announced the presentation of new preclinical data supporting its lead investigational compound, elunetirom, at the 64th Annual American College of Neuropsychopharmacology Annual Meeting (ACNP), being held in Nassau, Bahamas.
The newly presented findings further elucidate elunetirom’s novel mechanism of action and its ability to enhance restorative neuroplasticity—an underlying biological process critical to mood regulation, cognition, and long-term antidepressant response. Elunetirom is currently in Phase 2 clinical development as an adjunctive treatment for major depressive disorder (MDD) and bipolar depression, two conditions that continue to represent significant unmet medical need.
A Novel Approach to Restoring Brain Function in Depression
“These preclinical data demonstrate the potential for elunetirom to deliver rapid antidepressant effects by enhancing neuroplasticity and driving the persistent strengthening of neuronal synapses,” said Jonathan Meyer, MD, Voluntary Clinical Professor of Psychiatry at the University of California, San Diego. “Selective and potent activation of thyroid hormone receptor beta in the central nervous system represents a fundamentally different approach to treating depression compared to existing strategies, including the use of nonselective thyroid hormone agonists such as triiodothyronine.”
Dr. Meyer emphasized that elunetirom’s mechanism—targeted modulation of CNS thyroid hormone receptors to influence plasticity-related pathways—may directly address the underlying neural circuit dysfunction that persists in many patients who do not respond adequately to standard antidepressant therapies.
“Millions of people living with MDD and bipolar depression fail to achieve sufficient relief with currently available treatments,” he added. “There is a clear and urgent need for novel pharmacological approaches that work through differentiated biological mechanisms. I very much look forward to seeing the clinical data emerging from elunetirom’s ongoing development program.”
Strengthening the Biological Foundations of Neuroplasticity
Autobahn’s presentation at ACNP highlights how elunetirom directly regulates key molecular and cellular drivers of synaptic formation and strengthening. Among these is brain-derived neurotrophic factor (BDNF), a protein widely recognized for its role in promoting neuronal growth, synaptic plasticity, and cognitive function, and which has been consistently implicated in mood disorders.
“We are pleased to present new preclinical data that further characterize elunetirom’s direct impact on the core biological processes underlying synaptic formation and reinforcement,” said Gudarz Davar, M.D., Executive Vice President and Head of Research and Development at Autobahn Therapeutics. “These results provide strong mechanistic support for elunetirom’s role in driving energy-dependent neuroplasticity, reinforcing our confidence in its therapeutic potential as we continue our Phase 2 clinical studies.”
Dr. Davar noted that enhancing neuroplasticity in a sustained and biologically targeted manner may be essential to achieving durable antidepressant effects, particularly in patients whose symptoms persist despite treatment with conventional therapies.
Summary of ACNP Poster Presentation
Poster Title: Elunetirom, a first-in-class, brain-targeting antidepressant candidate in Phase 2 development, triggers robust hippocampal synaptogenesis and cognitive benefits in preclinical studies
The poster summarized a comprehensive series of in vitro and in vivo experiments designed to evaluate elunetirom’s effects on neuronal structure, synaptic connectivity, and cognition—factors highly relevant to the treatment of both MDD and bipolar depression.
In primary cultures of cortical neurons, elunetirom’s active metabolite significantly increased multiple measures of neuronal complexity, including total neuron count, neurite length, number of neurite roots, and neurite branching. These changes are considered foundational to the formation of functional neural networks.
In parallel experiments using mature hippocampal neuron cultures, elunetirom significantly enhanced markers of neuritogenesis and synaptogenesis, which are essential for learning, memory, and emotional regulation. Notably, in both experimental systems, the magnitude of these effects was comparable to those observed with optimal concentrations of BDNF, the positive control.
Beyond cellular models, elunetirom also demonstrated functional benefits in animal models. In aged mice and in mice treated with scopolamine—a compound commonly used to induce cognitive impairment—seven days of elunetirom treatment significantly improved spontaneous alternation performance in a T-maze task. These findings suggest measurable improvements in cognition that are likely linked to enhanced neuronal plasticity.
Collectively, the data indicate that elunetirom exerts its effects through direct regulation of genes that drive restorative neuroplasticity in the brain, including BDNF-related pathways.
Ongoing Clinical Development
Elunetirom is currently being evaluated as an adjunctive treatment for MDD in the ongoing Phase 2 AMPLIFY study and for bipolar depression in the Phase 2 AMPLIFY-BD study. Autobahn Therapeutics anticipates reporting topline data from AMPLIFY-BD in the second quarter of 2026 and from AMPLIFY in the third quarter of 2026.
With these new preclinical findings, Autobahn continues to build a robust translational foundation supporting elunetirom’s potential to address core biological deficits in mood disorders and deliver meaningful clinical benefit to patients who remain underserved by existing therapies.
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