Pioneering New Frontiers: Ovid Therapeutics' Journey to Revolutionize Epilepsy and CNS Treatment
By: Vera Kovacevic, PhD
Interviewees: Jason Tardio, Chief Operating Officer, Ovid Therapeutics
Dr. Toshiya Nishi, Senior Director, Drug Discovery, Ovid Therapeutics
Pioneering New Frontiers: Ovid Therapeutics' Journey to Revolutionize Epilepsy and CNS Treatment
By: Vera Kovacevic, PhD
Interviewees: Jason Tardio, Chief Operating Officer, Ovid Therapeutics
Dr. Toshiya Nishi, Senior Director, Drug Discovery, Ovid Therapeutics
In the US, epilepsy affects over 3 million adults and 470,000 children. Characterized by unpredictable seizures, epilepsy imposes significant burdens, not only due to the physical risks associated with seizures but also through profound social, psychological and economic impacts.
Despite advances in treatment, about one-third of people with epilepsy live with uncontrolled seizures because no available treatment works for them. It is against this backdrop that Ovid Therapeutics operates, driven by a mission to develop transformative medicines for epilepsy and related neurological conditions.
Through this interview with Jason Tardio, Chief Operating Officer at Ovid Therapeutics, and Dr. Toshiya Nishi, Senior Director, Drug Discovery at Ovid Therapeutics, we'll explore how Ovid's strategic vision has evolved to meet the complex needs of those living with epilepsy and other brain disorders. We'll delve into their innovative approaches, the challenges they face in drug development, the vital role of partnerships and their commitment to continuing a trajectory of innovation in central nervous system science.
Can you share how Ovid Therapeutics' mission to develop new medicines for epilepsies and brain conditions has evolved over the years?
Jason Tardio: Since its inception, Ovid Therapeutics has focused on rare neurodevelopmental disorders and rare epilepsies, and we’ve established a successful blueprint for developing epilepsy therapies. Because of that success, combined with our recognition of the degree of unmet need in epilepsy, we have doubled down on our efforts in this therapeutic area.
Despite existing treatment options, many people living with epilepsy still experience uncontrolled seizures, a substantial risk of drug-drug interactions and undesirable side effects that reduce quality of life, and strict monitoring requirements.
In our effort to improve lives, we are focused on developing novel approaches that could potentially be more effective medicines for epilepsy with improved safety profiles. We’re building on the learnings from our research to increase our understanding of additional seizure-related disorders, which will ultimately facilitate our work as we branch out into new areas of neuroscience.
What are some of the biggest challenges Ovid faces in the development and commercialization of new treatments for neurological and rare diseases?
Jason Tardio: I’ll focus my response specifically on the challenges we face in the neurological disease space. Developing medications and treatments for neurological disorders is particularly challenging because of the complexity of the nervous system.
But that’s not the only thing that makes it challenging — the blood-brain barrier is such a large hurdle that many companies choose not to focus on drug development for these conditions. The blood-brain barrier is crucial protection for the brain, but also serves as a significant challenge when developing drugs that need to penetrate the barrier to be effective and reach their targets.
There is also much we still don’t know about the underlying biological mechanisms of neurological disorders, making it difficult to identify suitable drug targets to drive R&D efforts.
Moreover, neurological disorders can present a wide range of symptoms with no defined disease progression patterns, meaning that effective medicines need to address multiple symptoms safely and effectively.
“Because of certain challenges [discussed above], many companies are hesitant to take on drug development in the neuroscience space. At Ovid Therapeutics, we see these challenges as opportunities."
— Jason Tardio, Chief Operating Officer, Ovid Therapeutics
“Because of certain challenges [discussed above], many companies are hesitant to take on drug development in the neuroscience space. At Ovid Therapeutics, we see these challenges as opportunities."
— Jason Tardio, Chief Operating Officer, Ovid Therapeutics
How do partnerships play a role in Ovid's strategy for advancing your research and development efforts?
Jason Tardio: Ovid Therapeutics has seen a lot of success with collaborations over the years, and I believe they play a crucial role in advancing R&D to bring new and better treatments to patients, faster.
For example, we collaborated with Takeda on the development of soticlestat, a potential first-in-class medicine that’s currently being evaluated in two Phase III trials for Lennox-Gastaut syndrome and Dravet syndrome. With Takeda’s resources and our expertise in rare neurological disorders, our Phase II development program was completed six months ahead of schedule.
By working with other companies, you expand your network of resources, including knowledge and expertise, technology, finances and more. Collaborations can help fill gaps your own company may have, speeding drugs to market as a result. We owe it to our patients, ourselves and our stakeholders to consider these collaborations, as they have promising potential to accelerate and advance drug development processes.
Looking ahead, how does Ovid Therapeutics plan to continue its trajectory of innovation in central nervous system (CNS) science and epilepsy treatment?
Jason Tardio: Ovid Therapeutics has developed what we believe to be a highly differentiated pipeline of small molecule assets that could fill unmet needs across a variety of different epilepsies and seizure-related disorders.
One of the most exciting and promising developments we will see in the near term will be Takeda’s Phase III soticlestat readout (of which we maintain a significant financial interest in its success), which is expected this summer. If the trial is a success, this therapy will be a very important addition to the treatment landscape for people living with Dravet syndrome and Lennox-Gastaut syndrome, both rare diseases. This, along with several additional promising and innovative potential therapies and drug targets, makes us excited about what we have done and what we’re doing at Ovid Therapeutics.
“Drug discovery with a new mechanism certainly has its own challenges, but the flip side is that it could offer a complementary option to currently available treatments, contributing not only to the advancement of medicine, but also to basic science."
— Dr. Toshiya Nishi, Senior Director, Drug Discovery, Ovid Therapeutics
“Drug discovery with a new mechanism certainly has its own challenges, but the flip side is that it could offer a complementary option to currently available treatments, contributing not only to the advancement of medicine, but also to basic science."
— Dr. Toshiya Nishi, Senior Director, Drug Discovery, Ovid Therapeutics
Can you share the journey and the challenges faced in the discovery of soticlestat and its novel mechanism of action?
Dr. Nishi: I was lucky enough to be involved in the discovery of soticlestat while I was employed by Takeda. Soticlestat is a potential first-in-class small molecule designed to inhibit a chemical modification of cholesterol in the brain, which is mediated by an enzyme called CH24H. Inhibition of this process was not seriously considered as a therapeutic opportunity at the time. Interestingly, though, soticlestat showed a survival benefit in a mouse model of Alzheimer's disease that’s known for seizure-related death, a discovery that led us to epilepsy.
Drug discovery with a new mechanism certainly has its own challenges, but the flip side is that it could offer a complementary option to currently available treatments, contributing not only to the advancement of medicine, but also to basic science.
How do you envision the impact of Ovid Therapeutics' research on the broader field of neuroscience and the treatment of rare diseases in the future?
Dr. Nishi: When I started working in epilepsy, the field was lacking innovation. Now, we drug hunters are increasingly aware that there are many untapped therapeutic opportunities.
For example, Ovid Therapeutics is advancing a KCC2 activator, a potential first-in-class program that may have therapeutic application in rare and common epilepsies, as well as other CNS indications.
Doing something new always comes with its own risks, but that is how science evolves. While Ovid Therapeutics is still a small company, we’re courageous enough to embody this basic philosophy of R&D in order to make a difference in patients’ lives.
The efforts of Ovid Therapeutics under the leadership of Jason Tardio and Dr. Toshiya Nishi exemplify the impact of dedicated research and innovative thinking in the field of neuroscience.
Through their focused approach on novel treatments for epilepsy and other rare neurological disorders, they are not just advancing medical science but also paving the way for new effective therapies that promise to improve the quality of life for millions affected by these challenging conditions.
ABOUT Jason Tardio
Jason Tardio is Chief Operating Officer and joined Ovid Therapeutics in November 2019 as Chief Commercial Officer. Prior to joining the Company, Mr. Tardio served as Vice President, Head of the multiple sclerosis franchise at Novartis (NYSE: NVS). There, he was responsible for developing and managing all aspects of the US commercial plan, brand P&L, strategy development and go-to-market modeling. Before Novartis, Mr. Tardio held roles of increasing responsibility at Biogen (NASDAQ: BIIB), where most recently he served as General Manager, Managing Director for Biogen’s Latin America South affiliate. Earlier at Biogen, Tardio held a wide range of sales and marketing roles of increasing responsibility, including positions in global commercial strategy, the US business unit and the international affiliates. He has two decades of commercial experience in the biopharmaceutical industry, which began at Wyeth and Sepracor, with roles in sales, sales training and marketing. Mr. Tardio holds a Bachelor of Science from The College of New Jersey and a Master in Business Administration in Pharmaceutical Marketing from St. Joseph’s University.
ABOUT Dr. Toshiya Nishi
Toshiya Nishi is a veterinarian by training. Spending more than 20 years on drug discovery and translational research at Takeda Pharmaceutical, he joined Ovid Therapeutics in 2023. While at Takeda, Dr. Nishi played a role in the discovery of soticlestat, which was then co-developed with Ovid. Now serving as Senior Director, Drug Discovery, Ovid Therapeutics, he is driving research of KCC2 activators.