Developing treatments to help those struggling with depression, a disorder that can lead to suicide, has become a mission for Shawn Singh, CEO of VistaGen, and his colleagues.
Shawn Singh, the chief executive officer of VistaGen, is passionate about finding ways to help people dealing with depression. Developing treatments to help those struggling with a disorder that can lead to suicide has become a mission for Singh and his colleagues.
As Singh looked over the landscape for depression treatment, he lamented that it is sadly a growing market space. While that growth is good for the bottom line of companies like VistaGen, he told BioSpace that the growing rate of depression in the United States is staggering. One in eight people over the age of 12 is on an antidepressant, he said. And the use of those medications is rising. Singh also noted that the rate of suicide is going down across the globe, except in the United States.
“We believe that depression should be treated aggressively. It’s nothing to be held quiet. It should be treated like a disease and attacked from a lot of different angles,” Singh exclaimed in an exclusive interview with BioSpace.
VistaGen has several medications in its pipeline that can address depression, including its most advanced asset, AV-101, a potential treatment for major depressive disorder. In October, AV-101 snagged Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of neuropathic pain associated with MDD. Neuropathic pain affects approximately 33 million people in the United States. It is characterized by a steady burning or sensation that results in abnormal neuronal function. It was the second such designation that AV-101, an investigational, orally bioavailable, small molecule NMDA (N-methyl-D-aspartate) receptor glycine B antagonist, earned from the FDA. In December 2017 it was granted the same designation for major depressive disorder.
Not only does AV-101 have the potential to help those who struggle with MDD, but also those who are dealing with the associated neuropathic pain. But, Singh is quick to point out that AV-101 could likely be a go-to treatment for prescribers because it is not an opioid. Singh noted that AV-101 is fast-acting and doesn’t have a lot of the safety concerns found with the use of opioids. He said there’s no “off-target” activity with the drug, so AV-101 goes where it’s supposed to go and rapidly addresses the issue. For many current CNS drugs, the “everywhere else aspect” has raised concerns regarding safety and the potential for abuse, particularly with the use of opioids. That’s good news, as the National Safety Council recently issued a report that showed that more people in the United States are more likely to die from an opioid overdose than a car crash.
This year, the company anticipates two readouts for AV-101 for major depressive disorder. If the efficacy and safety profiles continue, Singh said AV-101 could be a game-changing medication for the depression arena.
“We want to change the paradigm that exists with current drugs. We believe that they need to make the outcome better for patients,” he said.
In addition to AV-101, VistaGen is also developing PH10, a first-in-class, intranasally administered neuroactive steroid for MDD that it acquired in October 2018 from Pherin Pharmaceuticals. VistaGen is preparing to conduct Phase III trials for that acquisition. Just a month prior, the company also acquired PH94B, a first-in-class neuroactive pherine, which VistaGen is preparing for pivotal Phase II development as a nasal spray for acute on-demand treatment of social anxiety disorder (SAD). Social anxiety, which affects about 15 million people in the U.S., is also a serious issue in need of new treatments, Singh said. Currently, there is no FDA-approved treatment that provides rapid-acting relief for SAD and sedatives that are often prescribed off-label for people with the disorder have numerous side effects and safety concerns, Singh said. SAD can lead to depression, Singh noted, which is why he is excited about the new treatment option that complements the company’s other assets. VistaGen plans to initiate the Phase III trial in the first half of this year.
“We’re super excited about our depression plays. This will benefit millions of patients in this country as the drugs could change the paradigm of treatment for depression,” Singh said. “Mental health is a big problem and I’m glad that we’re part of the fight.”
