AbbVie to buy Gilgamesh Pharma Bretisilocin for Major Depressive Disorder
North Chicago: AbbVie and Gilgamesh Pharmaceuticals Inc. have announced a definitive agreement under which AbbVie will acquire Gilgamesh's lead investigational candidate, currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD).
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.
Positive topline results from a Phase 2a study of bretisilocin in MDD were recently announced, demonstrating a clinically impactful and statistically significant reduction in 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 robust 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.
"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."
"AbbVie's leadership in neuroscience and commitment to advancing innovative treatments make them the ideal partner to advance bretisilocin rapidly forward while enabling Gilgamesh to continue pursuing our broader mission of developing novel, transformative therapies for complex mental health and neurological conditions," said Jonathan Sporn, M.D., chief executive officer at Gilgamesh Pharmaceuticals.
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. The transaction is subject to customary closing conditions.
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.
For AbbVie, Covington & Burling LLP is acting as legal counsel. For Gilgamesh, Centerview Partners LLC is acting as exclusive financial advisor and Ropes & Gray LLP is acting as legal counsel.
