Autobahn Therapeutics presented full Phase II AMPLIFY‑BD results showing that adjunctive elunetirom produced rapid and sustained reductions in depressive symptoms in 21 adults with bipolar I or II disorder. Mean HAMD‑17 scores fell 16.8 points at six weeks, with 75% responding and 50% remitting. Participants also reported substantial functional recovery (62% improvement on the Sheehan scale; days lost to illness fell from 2.7 to 0.4 per week). The drug was generally well tolerated and has FDA Fast Track status.
Autobahn Publishes Full Phase II AMPLIFY‑BD Results — Elunetirom Shows Rapid, Sustained Benefit in Bipolar Depression
Elunetirom has received fast track designation from the FDA for adjunctive treatment of bipolar depression. Credit: Ground Picture / Shutterstock.com.
Autobahn Therapeutics has released the complete results from its Phase II AMPLIFY‑BD study evaluating elunetirom as an adjunctive therapy for adults with bipolar I or bipolar II disorder experiencing major depressive episodes. The full dataset was presented at Psych Congress 2026 in New Orleans and builds on previously reported topline findings.
Study design and population: AMPLIFY‑BD was an open‑label Phase II study that enrolled 21 adult participants. Patients received once‑daily oral elunetirom for six weeks in addition to their existing mood stabiliser or antipsychotic regimens; some participants were also taking selective serotonin or norepinephrine reuptake inhibitors.
Primary outcome: The primary endpoint was change from baseline on the 17‑item Hamilton Rating Scale for Depression (HAMD‑17) at six weeks. Investigators observed a mean HAMD‑17 reduction of 16.8 points at week 6, with mean decreases of 9.7 points at week 2 and 13.7 points at week 4, indicating a rapid onset of effect that was maintained through six weeks.
Response, remission and clinician measures: By week 6, 75% of participants met predefined response criteria and 50% achieved remission. Consistent improvements were seen on shorter and extended clinician scales (HAMD‑6 and HAMD‑29) and on the Clinical Global Impressions‑Bipolar (CGI‑Bipolar) Severity scale; these clinician‑rated measures correlated strongly across time points.
Patient‑reported outcomes and functioning: Participants reported meaningful functional gains. On the Sheehan Disability Scale, functioning improved by 62% at week 6. Average days lost to illness fell by 85%, from 2.7 days/week at baseline to 0.4 days/week. The Symptoms of Depression Questionnaire showed a 36% improvement.
Safety and tolerability: Elunetirom was generally well tolerated in this small open‑label cohort. There were no severe or serious adverse events judged related to treatment. The most commonly reported adverse events were dizziness, diarrhoea and decreased free thyroxine. Safety findings will need confirmation in larger, controlled trials.
Gudarz Davar, Chief Medical Officer and Head of R&D at Autobahn, said: "The complete AMPLIFY‑BD dataset aligns with our topline results across every measure. We saw meaningful gains in both clinician‑rated and patient‑reported outcomes at all time points — including a marked return to work and social engagement for many participants."
Regulatory and next steps: Elunetirom has received Fast Track designation from the US Food and Drug Administration for adjunctive treatment of bipolar depression. Separately, in September 2024 Autobahn initiated the AMPLIFY Phase II trial evaluating ABX‑002 as an adjunctive therapy for adults with major depressive disorder. Given AMPLIFY‑BD's small, open‑label design, confirmatory randomized controlled trials will be important to establish efficacy and safety more definitively.
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