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AbbVie to Acquire Gilgamesh Pharmaceuticals' Bretisilocin, a Novel, Investigational Therapy for Major Depressive Disorder
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Gilgamesh Pharmaceuticals has entered into a definitive agreement to be acquired by AbbViewhich will take over the development of bretisilocin (GM-2505), a leading investigational psychedelic compound for major depressive disorder (MDD). The acquisition, valued at up to $1.2 billion including an upfront payment and development milestones, highlights a growing interest in new approaches to psychiatric care. Bretisilocin is a novel, short-acting psychedelic compound designed to overcome the limitations of existing treatments in its class. While traditional psychedelic agents have shown promise for their rapid and robust antidepressant effects, their long psychoactive duration presents a significant challenge for clinical use.

Bretisilocin, a serotonin (5-HT)2A receptor agonist and 5-HT releaser, has demonstrated a shorter psychoactive duration while retaining extended therapeutic benefits. This key feature addresses a major hurdle in developing psychedelic-based therapies for broader application. Recent positive topline results from a Phase 2a study in MDD support this potential, showing that a single dose of bretisilocin led to a clinically significant and statistically robust reduction in the severity of depressive symptoms. As measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), patients receiving bretisilocin showed a remarkable -21.6 point reduction from baseline at Day 14, compared to a -12.1 point reduction for the low-dose comparator. The treatment was also well-tolerated, with no serious adverse events reported.

This acquisition is a significant move for AbbVie, underscoring its commitment to advancing innovative treatments for mental health conditions.

Dr. Roopal Thakkar, AbbVie's Executive Vice President, noted the urgent need for new solutions for patients who have not responded to other therapies. For Gilgamesh, the acquisition allows the company to rapidly advance its lead asset while also pursuing its broader mission. As part of the deal, Gilgamesh will spin off a new entity called Gilgamesh Pharma Inc., which will retain its employees and other pipeline programs, including its ongoing collaboration with AbbVie. This transaction builds upon a prior collaboration agreement between the two companies, with AbbVie now poised to lead the late-stage clinical development of bretisilocin, potentially bringing a transformative new option to patients with MDD.

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