What You Should Know:
– AbbVie and Gilgamesh Pharmaceuticals Inc. have announced a definitive agreement for AbbVie to acquire Gilgamesh’s lead investigational candidate, bretisilocin, which is in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD).
– The deal is valued at up to $1.2B, which includes an upfront payment and development milestones. As part of the acquisition, Gilgamesh will spin off a new entity that will operate under the name Gilgamesh Pharma Inc. to hold its employees and other programs, including its oral NMDA receptor antagonist blixeprodil (GM-1020), cardio-safe ibogaine analog, M1/M4 agonist program and existing collaboration with AbbVie.
Bretisilocin: A Next-Generation Psychedelic
Psychedelic compounds, specifically 5-HT2A receptor agonists, are gaining recognition as potential treatments for mental health disorders like MDD due to their rapid and durable antidepressant effects. However, a key challenge with existing agents in this class is their long duration of psychoactive experience.
Bretisilocin is a novel, next-generation psychedelic compound designed to address these challenges. It is a 5-HT2A receptor agonist and 5-HT releaser that has been shown to have a shorter duration of psychoactive experience while maintaining an extended therapeutic benefit.
The compound recently showed positive results in a Phase 2a study for MDD. A single dose of bretisilocin demonstrated a statistically significant reduction in the severity of depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). At Day 14, the 10mg dose of bretisilocin showed a -21.6 point change from the baseline MADRS score, compared to a -12.1 point change for a low-dose comparator, with the difference being statistically significant (p = 0.003). Bretisilocin was also well tolerated, with no serious adverse events reported.
“The field of psychiatry represents one of the most challenging areas in medicine, with a significant need for innovative solutions,” said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “This acquisition underscores our commitment to broadening and enhancing psychiatric care by investing in novel treatment approaches with the potential to reach patients for whom other treatments have been ineffective. We look forward to advancing bretisilocin to late-stage clinical development.”
