Axsome Therapeutics has wrapped its hands around an epilepsy candidate from AstraZeneca through an acquisition of Avenue Therapeutics' subsidiary Baergic Bio, in a deal potentially worth more than $83 million.
Axsome is after BAER-101, a phase 2 oral GABA receptor modulator that Baergic originally licensed from AstraZeneca in December 2019. Back then, it was known as AZD7325. Now, under Axsome’s control, the asset will be called AXS-17, according to a Nov. 6 release from Avenue.
Axsome plans to start prep for phase 2 epilepsy studies of the molecule next year, Axsome said in its Nov. 6 release.
New York-based Axsome is paying $300,000 upfront for Baergic, and will follow up with development and regulatory milestone payments of $2.5 million for AXS-17’s first indication and $1.5 million for every indication after, along with up to $79 million in sales milestones and potential royalties should the investigational candidate pan out into an epilepsy med.
In return, Axsome now holds 100% of the equity interests in Baergic and worldwide commercial, development and manufacturing rights to the former AstraZeneca asset, according to Avenue’s release.
“This transaction adds AZD7325, an earlier stage molecule with a differentiated mechanism of action, to our leading late-stage CNS portfolio,” Axsome CEO Herriot Tabuteau, M.D., said in the pharma’s release. “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.”
A neuroscience specialist, Axsome has three approved medicines in depression, migraine and excessive daytime sleepiness. AXS-17 joins a pipeline that recently hit a blockage, with the FDA in June refusing to review a new drug application for a fibromyalgia candidate that was licensed from Pfizer in 2020. The regulator determined that one of the trials supporting the application wasn’t rigorous enough, with Axsome now running a new phase 3 study as a result.
Axsome’s pipeline also includes another former Pfizer asset, reboxetine or AXS-12, which has a checkered past. Pfizer originally developed reboxetine for depression, with the asset securing a provisional approval from the FDA in 1999 that was yanked back a couple of years later. A 2010 analysis of the compound deemed it “ineffective and potentially harmful.” Axsome is reworking the troubled molecule into a potential treatment for narcolepsy.