• Collaboration to leverage AbbVie's psychiatry expertise and Gilgamesh's innovative research platform to develop next-generation neuroplastogens for the treatment of psychiatric disorders

NORTH CHICAGO, Ill. and NEW YORK, May 13, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Gilgamesh Pharmaceuticals today announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. This collaboration will leverage AbbVie's expertise in psychiatry and Gilgamesh's innovative research platform to discover novel neuroplastogens.

Classic psychedelic compounds provide novel mechanisms to address mental health disorders, and some have shown promising clinical efficacy where other treatments have been ineffective. However, these first-generation compounds may induce profound psychoactive effects, such as hallucinations, necessitating in-office administration and concomitant supportive care.

Next-generation versions known as neuroplastogens target mechanisms that have shown potential to provide significant clinical benefits and are designed to minimize the challenging effects seen with first-generation compounds. These new compounds hold substantial promise for treating a variety of psychiatric conditions, including mood and anxiety disorders. Gilgamesh has leveraged an innovative research platform to successfully identify lead compounds in this novel class of therapeutics.

"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," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research at AbbVie. "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."

"We are thrilled to partner with AbbVie, a global pharmaceutical company focused on innovation in psychiatric care, to address the pressing challenges in mental health treatment," said Jonathan Sporn, M.D., chief executive officer at Gilgamesh Pharmaceuticals. "Our collaboration will pioneer research of a new generation of therapies that hold great potential for improving patient outcomes."

Under terms of the agreement, AbbVie and Gilgamesh have agreed to research and develop a portfolio of next-generation therapeutics for psychiatric disorders. Upon exercise of the option, AbbVie will lead development and commercialization activities. Gilgamesh will receive an upfront payment of $65 million from AbbVie and is eligible to receive up to $1.95 billion in aggregate option fees and milestones, as well as tiered royalties from mid-single to low-double digits on net sales.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

About Gilgamesh Pharmaceuticals

Gilgamesh Pharmaceuticals is a clinical stage neuroscience biotech developing innovative, best-in-class new chemical entities (NCEs) that target the root causes of psychiatric diseases, moving away from symptom management towards rapid-acting and durable, disease modifying therapies. We do this by designing best-in-class NCEs acting through proven mechanisms, which are optimized for safety, efficacy, and patient access. Gilgamesh is advancing a diverse portfolio of programs, including two lead clinical programs, GM-1020 and GM-2505, which have both commenced Phase 2 studies in Major Depressive Disorder. Learn more about the company's therapeutic pipeline at https://www.gilgameshpharmaceutical.com/.

Forward-Looking Statements 

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.