AbbVie Inc. ( ABBV ) announced Monday that it will acquire Gilgamesh Pharmaceuticals Inc.’s lead investigational candidate for moderate-to-severe major depressive disorder (MDD).

The deal, valued at up to $1.2 billion, includes an upfront payment and development milestones for the bretisilocin program. As part of the transaction, Gilgamesh will spin off a new entity, Gilgamesh Pharma Inc., to manage its employees and other programs, such as blixeprodil (GM-1020) and a collaboration with AbbVie ( ABBV ).

The acquisition builds on their 2024 collaboration to advance next-generation psychiatric therapies..

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Psychedelic compounds, including 5-HT2A receptor agonists, have gained recognition as potential treatments for mental health disorders, such as MDD, because of their demonstrated rapid, robust, and durable antidepressant effects.

However, existing agents in this class are hampered by their long duration of psychoactive experience.

Bretisilocin, a 5-HT2A receptor agonist and 5-HT releaser, is a novel, next-generation psychedelic compound designed to address development challenges observed within this class of compounds.

Bretisilocin has been shown to exert a shorter duration of psychoactive experience, while retaining an extended therapeutic benefit.

Topline results from a Phase 2a study of bretisilocin in MDD were recently announced. They demonstrate a clinically impactful and statistically significant reduction in the severity of depressive symptoms versus low-dose active comparator, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

At Day 14, a single dose (10mg) of bretisilocin demonstrated antidepressant effect with a -21.6 point change from baseline in MADRS total score compared to a -12.1 point change from baseline for the low dose (1mg) active comparator (p = 0.003).

Bretisilocin was well tolerated with no serious adverse events.

Price Action: ABBV stock closed at $207.55 on Monday.

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