AbbVie has officially announced a strategic partnership with Gilgamesh Pharmaceuticals Inc
Under the agreed terms, AbbVie will acquire Gilgamesh’s lead investigational candidate i.e. Bretisilocin, which is currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD).
To understand the significance of such a development, we must take into account how psychedelic compounds, including 5-HT2A receptor agonists, have pretty much made a name for themselves as potential treatments for mental health disorders, such as MDD. This happens to be the case largely because of their tendency to deliver rapid, robust and durable antidepressant effects.
Having said so, though, most existing agents in this class are hampered by their long duration of psychoactive experience.
Against that, Bretisilocin happens to be a novel, next-generation psychedelic compound, geared towards addressing development challenges observed within this class of compounds. More on the stated candidate would reveal how it has already shown to exert a shorter duration of psychoactive experience, while simultaneously retaining an extended therapeutic benefit.
“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.
Anyway, expanding upon the given acquisition, AbbVie will buyout Gilgamesh’s Bretisilocin program for a sum worth $1.2 billion, inclusive of an upfront payment and development milestones. On top of that, Gilgamesh will also spin off a new entity that will operate under the name Gilgamesh Pharma Inc.
This new entity will be tasked with holding 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.
Another detail worth a mention relates to how the given transaction actually delivers a rather interesting follow-up to AbbVie and Gilgamesh’s 2024 collaboration and option-to-license agreement for advancing the development of next-generation therapies that can psychiatric disorders.
Markedly enough, the option-to-license also remains in effect and will be transferred to Gilgamesh Pharma Inc. in connection with the spin-out.
The development in question also builds upon the positive topline results from a Phase 2a study of bretisilocin in MDD, where the therapeutic was able to achieve 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.
In fact, at Day 14, a single dose (10mg) of bretisilocin showcased 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).
Founded in 2013, AbbVie’s rise up the ranks stems from discovering and delivering innovative solutions that, on their part, are capable of addressing serious health issues today and overcoming medical challenges of tomorrow. The company’s portfolio of solutions currently spans several therapeutic areas including immunology, oncology, neuroscience and eye care.
Turning our attention towards Gilgamesh Pharmaceuticals, it would be a clinical-stage neuroscience biotech best-known for conceiving innovative, best-in-class new chemical entities that transform the treatment for psychiatric diseases. This transition involves moving away from symptom management towards rapid-acting and durable therapies.
The company is presently focused on designing therapies through distinctive mechanisms, mechanisms which are optimized for safety, efficacy, and patient access.
Moving forward, Gilgamesh will look to advance a diverse portfolio of programs, including blixeprodil (GM-1020), an oral NMDA receptor antagonist which is set for a a Phase 2a study in Major Depressive Disorder during 2025.
“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.”
