By Fineline Cube 
American pharmaceutical giant AbbVie (NYSE: ABBV) has finalized a definitive agreement to acquire bretisilocin, an investigational therapy from Gilgamesh Pharmaceuticals, for the treatment of moderate‑to‑severe major depressive disorder (MDD). The transaction, valued at up to $1.2 billion in upfront and milestone payments, positions AbbVie to expand its portfolio in a market that remains underserved by rapid‑acting antidepressants.
Phase IIa Trial Highlights
- Single‑dose efficacy: A single 10 mg dose of bretisilocin produced a robust reduction in depressive symptoms versus a low‑dose active comparator.
- Rapid onset: The trial demonstrated symptom improvement within days, a critical advantage over conventional antidepressants.
- Safety profile: No serious adverse events were reported, supporting the drug’s tolerability.
Deal Structure
| Component | Details |
|---|---|
| Upfront payment | Announced at acquisition; specific amount not disclosed. |
| Milestone payments | Linked to regulatory approvals and commercial milestones. |
| Total value | Up to $1.2 billion across all payments. |
Gilgamesh’s Strategic Spin‑Out
Under the terms of the agreement, Gilgamesh will spin out a new entity, Gilgamesh Pharma Inc., to retain its remaining programs, including:
- Oral NMDA receptor antagonist – a novel approach to modulate glutamatergic signaling.
- Cardio‑safe ibogaine analog – a potential rapid‑acting antidepressant with an improved safety profile.
- M1/M4 agonist program – aimed at cognitive enhancement and neuroprotection.
Despite the spin‑out, Gilgamesh will keep its existing collaboration and option‑to‑license agreement with AbbVie, ensuring continued partnership on overlapping therapeutic areas.
Market Implications
- AbbVie: Diversifies its antidepressant pipeline, leveraging bretisilocin’s fast‑acting profile to compete with emerging agents such as ketamine and its derivatives.
- Gilgamesh: Gains capital and strategic focus while preserving its broader innovation agenda.
- Investors: The deal underscores the growing premium on rapid‑acting, targeted neuropsychiatric therapeutics, potentially driving further M&A activity in the sector.-Fineline Info & Tech