In an exclusive interview with The Fly, VistaGen Therapeutics (VTGN) CEO Shawn Singh talked about the company's portfolio, its ongoing clinical trials, collaborative relationships, and much more. Here are some highlights:

ELEVATE TRIAL: Discussing the company's ELEVATE trial, a Phase 2 study of AV-101 as an adjunctive treatment of major depressive disorder - MDD - in patients with an inadequate response to antidepressants, Singh highlighted that VistaGen has already achieved its targeted enrollment and said it is on track to deliver topline results of the study "before calendar year-end, as planned."

ADDITIONAL AV-101 TRIALS: Additional AV-101 trials are also ongoing. "The VA is sponsoring, and Baylor University is conducting, a Phase 1b study in healthy military veterans that we all hope will be the first-step supporting Phase 2a clinical development of AV-101 for treatment of suicidal ideation late next year," Singh noted, with potential preliminary results by year-end. Additionally, the executive said that VistaGen is in the planning stages for Phase 2a clinical development of AV-101 beginning in late-2020 for treatement of depression following successful ketamine therapy, as an oral/non-opioid treatment for neuropathic pain, and as an oral treatment for levodopa-induced dyskinesia experienced by Parkinson's disease patients.

PH10, PH94B STUDIES: VistaGen has also a second compound under development for major depressive disorder, PH10, a nasal spray which activates the GABA and CRH pathways, and a Phase 3 pivotal trial in social anxiety disorder – PH94B - that is approaching, with initiation estimated in the second half of 2020. Both have "an exceptional safety profile in studies to date and each with therapeutic potential in multiple large and growing mental health markets where current treatments are inadequate at meeting the needs of millions of patients," the CEO told The Fly. The executive noted that the company is currently preparing for a 200-patient Phase 2b study of PH10 as a standalone treatment for MDD.

COLLABORATIVE RELATIONSHIPS: Noting that the company is "always open to collaborative relationships" that enhance VistaGen's "potential to achieve optimal commercial benefits" from its product candidates, CEO Singh said that "in certain large and growing markets outside North America, such as China and Japan, and possibly the EU and Korea, partnering for Phase 3 development, and possibly some Phase 2 development, as well as commercialization of one or more of our product candidates may make the most sense strategically."

NOT 'A ONE-PRODUCT' COMPANY: While the executive acknowledged that some might see VistaGen as a "one-product, one-disease company," he argued that "nothing could be further from the truth." "We have three novel, differentiated, patent-protected, clinical-stage product candidates, each of which, as is often the case with the evolution of CNS products, has therapeutic and thus commercial potential for treatment of multiple diseases and disorders in multiple markets where current treatments are inadequate at meeting the needs of millions of patients," the CEO contended.

"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. A more detailed version of this interview to follow.

For more on VistaGen's ELEVATE trial click here.

For more on VistaGen's additional AV-101 trials click here.

For more on VistaGen's PH10 and PH94B studies click here.

For more on VistaGen's potential partnerships click here.

For more on VistaGen click here.