AbbVie is making a push into the psychedelic frontier as it joins forces with US-based Gilgamesh Pharmaceuticals to target therapies for psychiatric disorders.

The collaboration, which includes an option-to-license agreement, will see AbbVie pay Gilgamesh $65m upfront. The psychedelic specialist is also in line to receive up to $1.95bn in aggregate option fees and milestones, as well as royalties.

The two companies will team up in the research and development phases of potential therapeutics for psychiatric disorders. AbbVie will take on development and commercialisation duties if it chooses to option a programme.

The number of psychedelics being used in clinical trials to treat psychiatric disorders is growing as investment in the space ramps up. However, the area is still in its infancy and, while some treatments have shown promising efficacy in addressing mental health disorders, many clinical ventures have been ineffective. Chief among the issues with many of these first-generation drugs can be unwanted psychoactive side effects such as hallucinations, says AbbVie.

Founded in 2019, Gilgamesh is developing neuroplastogens – agents that induce rapid and long-lasting neuroplasticity. These compounds could minimise the side effects seen with existing psychedelic compounds whilst still exerting clinical benefit, as per the company. 

Gilgamesh currently boasts two Phase II clinical assets, notably GM-1020 and GM-2505, which are being evaluated for the treatment of major depressive disorder. GM-1020 is an oral NMDA receptor antagonist while GM-2505 is an agonist of the 5-HT2A (serotonin) receptor.

The pharma company is also working on an investigational new drug (IND) application for an oral non-hallucinogenic neuroplastogen named GM-5022.

AbbVie’s senior vice president and global head of discovery research Jonathon Sedgwick said: “Significant unmet need remains for people living with psychiatric disorders and we know that to innovate in this field, we need to pursue novel technologies and approaches.”

Classic hallucinogens such as LSD and psilocybin are often categorised separately from dissociative drugs. While both classes of drugs belong under the psychedelic umbrella, their effects differ. Hallucinogens cause distortions in perception of reality, whilst dissociative drugs cause a disconnect between mind, body, and environment. 

The psychedelic market is largely dominated by Johnson & Johnson’s dissociative drug Spravato (esketamine), which was approved in 2019 for addressing treatment-resistant depression. The drug made $700m last year and sales are estimated to grow to $2bn in 2029, according to GlobalData’s Pharma Intelligence Centre.

GlobalData is the parent company of Pharmaceutical Technology.

There are currently no FDA-approved ‘classic psychedelics’, though the space is gearing up for a landmark review in June this year when Lykos Therapeutics’s MDMA-mediated therapy goes under the FDA examination lamp. The biotech’s upcoming meeting with the FDA’s Psychopharmacologic Drugs Advisory Committee (AdCom) will mark the first time FDA experts formally debate a psychedelic treatment.

The speed of the market’s growth could hinge largely on the outcome of the AdCom meeting, though public perception towards psychedelics – which is still mixed – could yet prove a major obstacle to the treatment’s widespread implementation.