Autobahn Therapeutics has reported full results from its Phase II AMPLIFY-BD study of elunetirom as an adjunctive therapy for patients with bipolar I or bipolar II disorder experiencing major depressive episodes.
The results were presented during Psych Congress 2026, held in New Orleans, US.
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The announcement follows previous top-line data, with the full dataset indicating clinically meaningful and statistically significant results across both primary and multiple secondary outcomes.
The AMPLIFY-BD open-label trial involved 21 adult participants who received once-daily oral elunetirom for six weeks, in addition to existing mood stabiliser or antipsychotic regimens, with or without selective serotonin or norepinephrine reuptake inhibitors.
The primary endpoint measured the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) after six weeks.
Investigators observed a mean HAMD-17 reduction of 16.8 points at week six, with reductions of 9.7 and 13.7 points at weeks two and four, respectively, suggesting a rapid and sustained effect.
Further analysis revealed a 75% response rate and a 50% remission rate at week six.
Improvements were also seen in the HAMD-6 and HAMD-29 scores, as well as the Clinical Global Impressions-Bipolar Severity scale, with high correlations between these measures throughout the study.
Patient-reported assessments highlighted significant gains in day-to-day functioning. According to the Sheehan Disability Scale, patients experienced a 62% improvement at week six.
The number of days lost due to illness declined by 85%, from 2.7 to 0.4 days per week. There was also a 36% improvement reported on the Symptoms of Depression Questionnaire.
Autobahn Therapeutics reported that elunetirom was generally well tolerated. There were no severe or serious treatment-related adverse events, with the most common being dizziness, diarrhoea, and reduced free thyroxine.
Autobahn chief medical officer and research and development head Gudarz Davar said: “The complete AMPLIFY-BD dataset is consistent with our topline results on every measure. We observed meaningful improvements in both clinician-rated and patient-reported outcomes, at every time point evaluated.
“Participants went from losing nearly three days a week to their illness to losing less than half a day, and they reported getting back to work and re-engaging with their families and in their social lives.
“We believe this is the greatest outcome that can be offered to patients who struggle with depression, and one that remains difficult to achieve with currently available adjunctive options.”
Elunetirom has received fast track designation from the US Food and Drug Administration for adjunctive treatment of bipolar depression.
In September 2024, Autobahn began the AMPLIFY Phase II trial, which is assessing ABX-002 as an adjunctive treatment for major depressive disorder in adults.
