In a hopeful harbinger of things to come, the new leader of the University of California’s drug discovery incubator also served as a key contributor to the development of the first drug treatment specifically approved for postpartum depression.
In March Sage Therapeutics announced U.S. Food and Drug Administration approval of its product, Zulresso™ (brexanolone) injection, for the treatment of postpartum depression in women. Initial development of an intravenous formulation of allopregnanolone (also known as brexanolone) and first-in-human clinical studies were conducted by Michael Rogawski, M.D., Ph.D., a professor in UC Davis’ neurology and pharmacology departments and former neurology chair.
In October, Rogawski became principal investigator for the University of California Drug Discovery Consortium, a group of researchers across five UC campuses working to translate basic science discoveries into new therapies that could benefit people worldwide.
For the new postpartum drug treatment, Rogawski and colleagues used laboratory and clinical research to investigate the neuroactive steroid allopregnanolone as a potential therapeutic agent for neurological diseases. UC granted rights to Sage Therapeutics, including licenses to certain patent rights, for commercial use.
The naturally occurring neuroactive steroid is derived from the female sex hormone progesterone. Levels rise dramatically as pregnancy progresses, but begin to decrease in late pregnancy and then fall precipitously during the day or two after giving birth.
“I reasoned that allopregnanolone levels might also fall, and I hypothesized that the withdrawal of this endogenous antidepressant substance could trigger depression for some women,” Rogawski said.
Rogawski also continues to contribute his expertise through the UC Drug Discovery Consortium, launched by five UC campuses in 2017 as a response to the evolving drug discovery and development landscape — and the view that UC is well positioned to help create treatments for important unmet medical needs.
“The pharmaceutical industry has been changing dramatically in recent years,” Rogawski said. “… Large companies are doing less in the way of early-stage research, which means they are more interested in products that have undergone some degree of early-stage development.”
In April the consortium announced its first partnership, an agreement with Astellas Pharma that provides seed funding for early-stage drug discovery research.