BioPharma, Pharma

AbbVie Expands Psychiatric Drug Prospects, Inking R&D Pact With Neuroscience Startup

AbbVie’s alliance with Gilgamesh Pharmaceuticals is pursuing next-generation psychiatric medications. The companies aim to bring patients drugs that offer the benefit of psychedelics but with a better side effect profile.

AbbVie has a blockbuster mental health medication in Vraylar, but the psychiatric drug pipeline behind it is thin. The pharmaceutical giant is bolstering its drug prospects through a new research alliance with Gilgamesh Pharmaceuticals, a clinical-stage startup aiming to develop therapies with advantages over psychedelic medicines.

North Chicago-based AbbVie is kicking off the new alliance by paying Gilgamesh $65 million up front, according to deal terms announced Monday. Specific targets or disease indications were not disclosed.

Psychedelic drugs leverage neuroplasticity, which is the brain’s ability to change and adapt. While the changes can result in patient benefit in indications such as depression, these drugs also cause psychoactive effects and hallucinations. That’s why patients must take these drugs in a treatment center under the supervision of a clinician. The drug candidates of Gilgamesh are neuroplastogens that also work by neuroplasticity. But the New York-based company says its drugs are designed to minimize the side effects of first-generation psychedelics.

Gilgamesh is part of a wave of emerging companies working to improve on psychedelic medications. The startup discovers its drugs with a platform technology that uses machine learning algorithms to characterize the bioactivity of known and novel psychoactive molecules. The company claims this approach enables it to design new drugs that are optimized for safety, efficacy, and patient access. The Gilgamesh technology has produced two clinical-stage programs, GM-1020 and GM-2505, both of which are in mid-stage clinical development for major depressive disorder.

AbbVie’s Vraylar has approvals in schizophrenia, bipolar disorder, and major depressive disorder. The drug joined the AbbVie portfolio as part of the $63 billion Allergan acquisition, which closed in 2020. Vraylar accounted for more than $2.7 billion in revenue last year, a 35% increase over sales in the prior year, according to AbbVie’s annual report. The vast majority of those sales came from the U.S. The AbbVie neuroscience pipeline lists one psychiatric drug candidate, a small molecule called ABBV-932. This selective D3 dopamine receptor modulator is in Phase 1 testing for bipolar depression under a partnership with Gedeon Richter, the Budapest-based company that initially developed Vraylar. AbbVie is also in the process of acquiring Cerevel Therapeutics in a an $8.7 billion deal that includes emraclidine, a schizophrenia drug in mid-stage clinical development.

Under AbbVie’s agreement with Gilgamesh, the two companies will work together in the research and development of a portfolio of novel psychiatric therapies. The North Chicago-based pharmaceutical giant has the option of leading development and commercialization for programs that stem from the collaboration. Gilgamesh is eligible for up to $1.95 billion in option fees and milestones. It will also receive royalties from AbbVie’s sales of any approved products.

“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,” Jonathon Sedgwick, AbbVie senior vice president and global head of discovery research, said in a prepared statement. “We look forward to working with Gilgamesh’s world-class team to advance the development of novel neuroplastogens and pave the way for additional treatment approaches in psychiatry.”

Gilgamesh was founded in 2019 by Dr. Jonathan Sporn, who had previously founded Perception Neuroscience. The startup unveiled a $27 million Series A financing in 2021. Gilgamesh last raised money in late 2022, a $39 million Series B round of financing. Prime Movers Lab led both financings.

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