1. How has your career led you to VistaGen, and why did you choose to move into CNS biopharmaceuticals?
I am passionate about addressing the mental health crisis in the U.S. and many other countries around the world. Anxiety, depression, and suicide, as well as abuse and overuse of certain CNS drugs, such as benzodiazepines and opioids, are destroying lives, families, and communities. There is a lot of room for improvement in the CNS sector – room to make a difference in the lives of millions of patients, their families, and caregivers – with differentiated, new-generation drugs that work faster and have fewer side effects and safety concerns than current drug treatment alternatives. In my nearly three decades of experience working in the biopharmaceutical, contract research and healthcare venture capital sectors, I have seen, time and time again, that many complex CNS disorders, such as depression, pain, social anxiety, and suicidal ideation, remain high unmet medical needs for countless patients who are suffering with inadequate alternatives. Unfortunately, for many neuropsychiatric and neurological diseases and disorders, there is no ‘one size fits all’ solution. Still, new generation treatment alternatives are emerging, and there is reason to believe new hope is on the horizon.
Our team at VistaGen is committed to developing and bringing to market faster-acting, safer and more convenient treatment options for numerous CNS diseases and disorders that we believe affect millions of patients worldwide but are inadequately addressed with the treatment options currently available to them today. New generation medicines, like the ones in VistaGen’s pipeline, have the potential to drive real, meaningful change to a sector of the biopharmaceutical industry that has seen little innovation in decades. Our goal is to make a difference for patients across a wide range of CNS diseases and disorders and, in doing so, deliver extraordinary value to our stakeholders.
2. How would you describe VistaGen’s place in the pharmaceutical marketplace?
Current drug treatment options for many neurological and mental health disorders, such as Social Anxiety Disorder (SAD), Major Depressive Disorder (MDD), dyskinesia, and pain, are associated with important limitations that make them inadequate options in the daily lives of large numbers of patients. Slow onset of action, side effects such as anxiety, sedation, and sexual dysfunction, as well as psychological side effects (such as dissociation and hallucinations) and safety concerns related to blood pressure, the potential for addiction and unwanted drug–drug interactions leave many patients without solutions to CNS conditions that disrupt their daily lives.
VistaGen’s pipeline includes three differentiated clinical-stage drug candidates focused on correcting many of these issues. Each drug candidate in VistaGen’s multi-asset, clinical-stage CNS pipeline includes has exciting potential for convenient take-home use, rapid-onset therapeutic benefits and an exceptional side effect and safety profile. In fact, VistaGen is the only company with an innovative asset entering Phase 3 development for the treatment of SAD. If successful in Phase 3 and approved, PH94B would become the first FDA-approved on-demand treatment for patients with SAD, a very large-market indication affecting 20 million people in the U.S. alone, in part as a result of increasing pressures and stress related to social media and team orientation in academic and work environments.
3. In your 10+ years as CEO of VistaGen, what would you say has been the most significant change(s) to the CNS pharmaceutical market?
While some leaders in the large Pharma industry are now predicting that the 2020s will be the decade of neuroscience, that has not always been the prevailing sentiment over the past 10+ years. For many years in the past, the absence of drug candidates with differentiated mechanisms of action, combined with setbacks in high-profile indications (such as Alzheimer’s), a lack of transformative CNS-related licensing and M&A transactions and limited media attention to, and general awareness of, pervasive social issues relating to mental health challenges, had caused the investment community to focus elsewhere. All of that has changed, seemingly 180 degrees, in recent years. That market transformation, together with regulatory advances, has improved funding for the development and commercialization of new generation CNS medications.
As the global CNS therapeutic market is set to reach a compound annual growth rate of 5.9 percent from 2016 to 2025, and projected to ultimately reach 129 USD billion, I am glad to see that there is increased attention and awareness of the CNS space, which includes a host of different diseases and an enormous patient population with numerous unmet medical needs. As the industry continues to grow, there still remains a lack of innovative new treatments on the market for disorders related to anxiety and depression like MDD and SAD, and that is where VistaGen’s leadership and pipeline will play a significant role in CNS. Our mission is to change the game for patients and their caregivers with our new generation therapeutics and offer hope to the millions of patients who are in dire need of new treatment options for their mental health and neurological conditions.
4. What regulatory challenges/or other obstacles does VistaGen face when bringing new CNS drugs from development to the clinic and, eventually, to commercialization?
As with all innovative drugs across numerous therapeutic areas, drug development is complex, costly and time-consuming. Development of drugs that are expected to work in the brain and the CNS must be conducted carefully and efficiently. The primary challenges are funding and time. The regulatory framework is well established and not particularly unique for new CNS drugs. If anything, we have seen some progressive movement by the FDA in the CNS arena, notably regarding neuropsychiatry product candidates for depression, as demonstrated, for example, by the recent approval of adjunctive esketamine nasal spray for TRD, the NDA for which was supported in part by a maintenance of effect study, rather than a second and more conventional efficacy study.
5. Which projects in the VistaGen pipeline are you particularly excited for?
I am excited about the prospects across our entire pipeline. We have many potential clinical-stage shots on goal. Right now, we are preparing to begin our Phase 3 clinical development program for our neuroactive nasal spray PH94B as a potential game-changing therapy for SAD. As mentioned above, if successful in Phase 3 and approved, PH94B would become the first FDA-approved on-demand treatment for SAD. Self-administered in non-systemic microgram doses potential for with rapid-onset effects without sedation or risk of addiction, we also see exciting applications for PH94B in maternal mental health, such as postpartum anxiety, preoperative anxiety, and other anxiety-related disorders where current oral treatment options are systemic (which is a particular issue in maternal mental health indications), sedative and potentially addictive. I am also excited about the vast potential of PH10 for rapid-onset benefits in MDD, TRD, and suicidal ideation and AV-101’s potential as a new non-opioid, non-sedating option for the treatment of pain, and dyskinesia associated with levodopa therapy for Parkinson’s disease.
6. Currently, VistaGen focuses on developing drugs for CNS conditions with high unmet need, such as major depressive disorder, neuropathic pain, social anxiety disorder, and suicidal ideation. Has there been any discussion of broadening your field of research to other CNS indications?
One of our drug candidates, AV-101, is a new generation oral platform therapy. We believe AV-101, when given with probenecid has exciting potential as a differentiated at-home treatment for both neuropsychiatry and neurological indications, including MDD, suicidal ideation, chronic neuropathic pain (as a safe, non-addictive alternative to opioids), epilepsy, and dyskinesia in Parkinson’s disease patients receiving levodopa therapy (as an alternative to amantadine therapy, which can cause psychological side effects). We are constantly looking for ways to expand our pipeline and IP portfolio to support our overarching mission of bringing new generation CNS treatments to market for patients in need all over the globe.
7. The PH94B nasal spray for social anxiety disorder has recently been granted Fast Track Designation by the FDA. Should approval be granted, what is the company’s vision for the drug?
With positive Phase 2 data, VistaGen is preparing PH94B for Phase 3 development of PH94B for SAD. Conveniently self-administered in non-systemic microgram doses on-demand, PH94B has potential to be the first fast-acting, non-sedating, as-needed treatment for as many as 20 million individuals in the U.S. and millions more around the globe suffering from SAD. We plan to develop and commercialize PH94B in North American markets on our own and partner for such activities in key regional markets globally.
8. Beyond the existing drugs in your pipeline, what direction would you like to see VistaGen pursue in the next five to 10 years?
There is not now, nor will there ever be, a one-size-fits-all, one-and-done magic bullet solution for many, if not most, complex neuropsychiatry and neurological diseases and disorders. We will continue to pursue further innovation and seek to acquire, develop, and commercialize additional differentiated CNS product candidates to leverage our strengths. The next five to 10 years are expected to be tremendously exciting and transformative for VistaGen, as we direct our efforts to completing late-stage clinical development, seeking market approval of (and on our own in the U.S. and with multiple strategic partners elsewhere around the world) our current pipeline across a broad range of CNS indications. At the same time, we will be focused on expanding our CNS product portfolio to capture future innovation.
Disclaimer
The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of Taylor & Francis.
Declaration of interest
The interviewee is the chief executive officer and director of VistaGen Therapeutics. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or conflict with the subject matter or materials discussed in this manuscript apart from those disclosed.