A treatment for patients with bipolar I or bipolar II depression has demonstrated durable antidepressant effects, results show.

Elunetirom, developed by Autobahn Therapeutics, is a novel, oral, once daily, brain-penetrant CNS thyroid hormone receptor agonist.

In the Phase II AMPLIFY-BD trial, elunetirom was evaluated as an adjunctive treatment in patients with bipolar I or bipolar II depression. Patients received oral elunetirom once daily for six weeks in addition to their existing mood stabiliser and/or atypical antipsychotic regimen.

Results show elunetirom led to a rapid and robust antidepressant response in patients as early as week 6, with a 75% response rate and 50% remission rate also observed.  The treatment led to meaningful improvements in symptoms across all clinical assessments, enhanced brain network connectivity, and was generally safe and well tolerated.

Elunetirom previously received Fast Track designation from the US Food and Drug Administration (FDA) for the adjunctive treatment of bipolar depression.

“The consistency of effect we observed with elunetirom across multiple measures of depression, including core symptom severity and functional impairment, is very promising,” said Gudarz Davar, Chief Medical Officer and Head of Research and Development at Autobahn.

“Importantly, the rapid onset of activity and tolerability profile support the potential for elunetirom to deliver meaningful and durable benefit for patients without adding treatment burden.

“We were also highly encouraged to observe changes in functional connectivity in bipolar depression patients treated with elunetirom, giving objective evidence that elunetirom can lead to neuroplastic remodelling in regions and functional networks of the brain affected by depression.

“The totality of clinical and neurobiological evidence from AMPLIFY-BD points to a strong potential for elunetirom to offer a meaningfully differentiated treatment option for the millions living with bipolar depression and major depressive disorder.”