AbbVie Enters Psychedelic Market With Bretisilocin Acquisition
By Katie Anderson, Chief Editor, Pharmaceutical Online
AbbVie has agreed to acquire bretisilocin (GM-2505) from Gilgamesh Pharmaceuticals Inc. for $1.2 billion. Bretisilocin is Gilgamesh’ lead investigational candidate for the treatment of patients with moderate-to-severe major depressive disorder (MDD). It is a next-generation psychedelic compound (5-HT2A receptor agonist and 5-HT releaser) designed to exert a shorter duration of psychoactive experience, while retaining an extended therapeutic benefit.
Bretisilocin is currently in phase two clinical trials. Positive topline results from a phase 2a study of bretisilocin in MDD demonstrated a clinically impactful and statistically significant reduction in severity of depressive symptoms versus low dose active comparator. Bretisilocin was well tolerated with no serious adverse events.
"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, in a company press release. "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."
Under the terms of the agreement, AbbVie will acquire Gilgamesh's bretisilocin program for up to $1.2 billion, inclusive of an upfront payment and development milestones. Additionally, as part of the transaction, 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.
This transaction builds upon AbbVie and Gilgamesh's 2024 collaboration and option-to-license agreement to advance the development of next-generation therapies for the treatment of psychiatric disorders. This option-to-license remains in effect and will be transferred to Gilgamesh Pharma Inc. in connection with the spin-out.