Axsome Therapeutics announced that it has obtained exclusive global rights to AZD7325, a selective GABAA α2,3 receptor positive allosteric modulator that has previously completed Phase 1 studies. AstraZeneca initially developed the program. Axsome plans to advance AZD7325 into Phase 2, enabling activities in 2026 as a potential treatment for epilepsy.
The acquisition strengthens Axsome’s neuroscience portfolio by adding an early-stage epilepsy asset with a differentiated mechanism of action. The company stated that AZD7325 has demonstrated anti-convulsant effects in preclinical seizure models and has shown a favorable safety and tolerability profile in clinical studies involving more than 700 patients.
The transaction provides Axsome with global commercial, development, and manufacturing rights to AZD7325. The rights were obtained through the acquisition of a 100 percent equity interest in Baergic Bio, a subsidiary of Avenue Therapeutics, and an amendment to Baergic Bio’s existing license agreement with AstraZeneca. Under the Baergic Bio purchase agreement, Baergic Bio shareholders will receive a $0.3 million upfront payment. They may receive development and regulatory milestone payments of $ 2.5 million for the first indication and $ 1.5 million for each additional indication, along with up to $ 79 million in potential sales-based milestones and a tiered mid-to-high single-digit royalty on potential global net sales.
Under the amended license terms, AstraZeneca will receive a cash upfront payment in the single-digit millions and may also receive development and regulatory milestone payments for each indication, sales-based milestones, and a tiered mid-to-high single-digit royalty on future global net sales of AZD7325.
Epilepsy affects approximately 3.4 million people in the United States, with about 150,000 new cases diagnosed annually. It is a chronic neurological condition involving recurrent and unprovoked seizures. Despite available therapies, more than one-third of individuals with epilepsy do not respond adequately to current treatments, contributing to a significant impact on daily functioning and quality of life.
KEY QUOTE:
“This transaction adds AZD7325, an earlier stage molecule with a differentiated mechanism of action, to our leading late-stage CNS portfolio. We are excited to further deepen our research pipeline in a complementary way, and to extend our clinical efforts into epilepsy, an area where there is an urgent need for innovative new treatment options for patients.”
Herriot Tabuteau, MD, Chief Executive Officer of Axsome
