Autobahn Therapeutics has released full results from its Phase II AMPLIFY-BD study, examining elunetirom as an adjunctive treatment for patients with bipolar I or II disorder experiencing significant depressive episodes. This announcement was made during the Psych Congress 2026 in New Orleans, US.
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The study's findings followed earlier top-line data, revealing clinically meaningful and statistically significant results across primary and multiple secondary outcomes. In the open-label trial, 21 adult participants received once-daily oral elunetirom for six weeks, alongside their existing mood stabilizer or antipsychotic treatments, which may or may not have included selective serotonin or norepinephrine reuptake inhibitors.
The primary measure was the change from baseline on the 17-item Hamilton Rating Scale for Depression (HAMD-17) after six weeks. Results showed a mean reduction of 16.8 points in HAMD-17 scores at week six, with reductions of 9.7 and 13.7 points noted at weeks two and four, indicative of both rapid and sustained effectiveness.
Further analysis demonstrated a 75% response rate and a 50% remission rate by week six. There were also improvements in HAMD-6 and HAMD-29 scores, as well as in the Clinical Global Impressions-Bipolar Severity scale, with these measures displaying strong correlations throughout the study.
Patient-reported outcomes indicated significant enhancements in daily functioning, with the Sheehan Disability Scale showing a 62% improvement at week six. Additionally, the number of days lost due to illness dropped by 85%, from 2.7 to 0.4 days per week, alongside a 36% improvement on the Symptoms of Depression Questionnaire.
The study noted that elunetirom was generally well tolerated, with no severe or serious treatment-related adverse events reported. The most common side effects included dizziness, diarrhea, and reduced free thyroxine levels.
Gudarz Davar, Autoban's Chief Medical Officer, remarked that the complete dataset aligns with the topline results across all measures, reflecting meaningful improvements in both clinician-rated and patient-reported outcomes. He emphasized the positive outcome of significantly reducing the number of days lost to illness, which enabled participants to better engage with work and family life.
Elunetirom has received fast track designation from the US Food and Drug Administration for the adjunctive treatment of bipolar depression. Additionally, Autobahn initiated the AMPLIFY Phase II trial in September 2024, evaluating ABX-002 for major depressive disorder in adults.