AbbVie partners with Gilgamesh in $2bn psychedelic deal

AbbVie is venturing into the psychedelic domain through a collaboration with US-based Gilgamesh Pharmaceuticals to develop therapies for psychiatric disorders. This partnership involves an option-to-license agreement, with AbbVie providing an upfront payment of $65 million to Gilgamesh. In total, Gilgamesh could receive up to $1.95 billion, including milestone payments and royalties.

The primary focus of this collaboration is on research and development for potential psychiatric therapeutics. If AbbVie opts to license any of the programs, it will handle their further development and commercialization. The number of psychedelic compounds undergoing clinical trials for psychiatric disorders is on the rise as investments in this area grow. Despite some promising results, many clinical attempts with first-generation psychedelics have been ineffective, often due to unwanted psychoactive side effects such as hallucinations.

Gilgamesh, founded in 2019, is at the forefront of developing neuroplastogens, which are compounds capable of inducing rapid and lasting neuroplasticity without the psychoactive side effects typically associated with psychedelics. These agents could potentially offer clinical benefits while minimizing the side effects seen with existing psychedelic compounds.

Currently, Gilgamesh has two Phase II clinical assets: GM-1020 and GM-2505. GM-1020 is an oral NMDA receptor antagonist, and GM-2505 is an agonist of the 5-HT2A (serotonin) receptor. Both are being evaluated for the treatment of major depressive disorder. Additionally, Gilgamesh is working on an investigational new drug (IND) application for GM-5022, an oral non-hallucinogenic neuroplastogen.

Jonathon Sedgwick, AbbVie's senior vice president and global head of discovery research, emphasized the significant unmet needs for those living with psychiatric disorders and highlighted the necessity of pursuing novel technologies and approaches to innovate in this field.

Classic hallucinogens such as LSD and psilocybin differ from dissociative drugs. While both fall under the psychedelic category, hallucinogens cause distortions in reality perception, whereas dissociative drugs lead to a disconnect between the mind, body, and environment.

The psychedelic market is currently dominated by Johnson & Johnson's dissociative drug Spravato (esketamine), which was approved in 2019 for treatment-resistant depression. Last year, Spravato generated $700 million in sales, with projections estimating growth to $2 billion by 2029 according to GlobalData’s Pharma Intelligence Centre.

There are no FDA-approved classic psychedelics at present. However, the sector is approaching a significant milestone with an upcoming FDA review of Lykos Therapeutics’s MDMA-mediated therapy in June this year. This meeting with the FDA’s Psychopharmacologic Drugs Advisory Committee (AdCom) will be the first formal review of a psychedelic treatment by FDA experts.

The future growth of the psychedelic market may largely depend on the outcomes of the AdCom meeting. Public perception of psychedelics, which remains mixed, could also play a critical role in the widespread adoption of these treatments.