Central Focus: Targeting Unmet Need in CNS

In his first year as president and CEO of Sunovion Pharmaceuticals, Antony Loebel, MD, shared with Pharmaceutical Executive some memorable events. They included the approval of KYNMOBI™ sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease; the presentation of positive data for a four-week pivotal study (SEP361-201) evaluating the safety and efficacy of SEP-363856 in patients with schizophrenia, published in The New England Journal of Medicine (NEJM); and leading the company through COVID-19. While the events themselves are remarkable, the way Loebel speaks to them is humbly phrased and inclusive of patients, Sunovion’s parent company, Sumitomo Dainippon Pharma, and his colleagues. 

“It’s been my privilege to be president and CEO of Sunovion since April 1, 2019. I’m now in the second year in my role,” says Loebel. “I’m still feeling relatively new at the role and learning, and I’m extremely grateful for the support and the interaction that I have on a daily basis with all of my colleagues.”

Dr. Antony Loebel, President and CEO, Sunovion Pharmaceuticals

Prior to joining Sunovion in 2007 (known then as Sepracor before becoming Sunovion with the acquisition and name change by Sumitomo Dainippon Pharma in 2009), Loebel worked for seven years in drug development and medical affairs roles at Pfizer. During his tenure at Sunovion, Loebel has provided strategic direction and leadership of R&D, including overseeing the global clinical development organization, where he directed initiatives designed to improve global R&D operational efficiency and to address unmet medical needs through innovation in drug development. 

“What I’ve encountered is that the CEO has a unique role and place in a company’s ecosystem,” says Loebel. “The CEO’s perspective is overarching and allows for a unique understanding of the way in which all parts of the company interact, which is also necessary to help come up with solutions and best possible outcomes.” 

To that end, he has continued to align the various interests in the company to ensure that it remains focused on major objectives, and that those organizations and functions all pull together in the same direction. The CEO, working with the executive leadership team and others, also needs to ensure that employees are inspired and motivated based on a clear understanding of the company’s direction and its corporate vision, he says. 

Loebel shared a quote from John Quincy Adams, which is part of his beliefs: “If your actions inspire others to dream more, learn more, do more, and become more, you are a leader.”

Early lens on unmet needs

While Loebel can look back on his past 20 years in the pharmaceutical industry, perhaps his propensity to observe his current experience and learn from it is grounded in his training and work with patients in the field of psychiatry. 

Loebel earned his MD from the University of Washington School of Medicine in Seattle. He completed his residency in psychiatry and a research fellowship in clinical neurosciences at Zucker Hillside Hospital in Queens, NY, (now the Northwell Health System), which is renowned for its psychiatric research. Loebel specifically focused on treating patients with schizophrenia and other forms of serious mental illness. While he treated patients individually and in small groups so that he could impact them positively, it was difficult to make an impact on the overall illness burden associated with neuropsychiatric disease, which was both alarming and overwhelming.

“While I could advance individual patient’s mental health as an attending physician, I wanted to find solutions that could directly impact the lives of larger patient populations,” explains Loebel. And that impact, he soon discovered through his work as a clinical researcher, could be achieved through new and innovative therapies that could help reduce the illness burden for patients with neuropsychiatric conditions.

This focus on innovation to bring novel therapies to patients is what has sustained Loebel for the last two decades and is the theme that runs throughout his professional career.

Loebel’s first role in the pharma industry was with the medical affairs team at Pfizer, educating clinicians on the antipsychotic treatment Geodon® (ziprasidone HCI). Pfizer conducted clinical studies with Geodon to explore its use outside of its foundational indication of schizophrenia, and Loebel was responsible for development programs in bipolar depression and other indications and formulations. While Loebel felt this experience represented an important contribution toward improving the lives of people with serious mental illness, he wanted to explore opportunities in the earlier R&D ecosystem and focus on identifying and developing novel medications.

In 2007, Loebel joined the Sumitomo Dainippon Group as vice president of clinical development to work on one of its medications in development that came to be known as Latuda® (lurasidone HCl). The drug is currently approved to treat adults and adolescents with schizophrenia, as a monotherapy for adults and pediatric patients with bipolar depression, as well as an adjunctive treatment with lithium or valproate in adults with bipolar depression.

In executing an efficient development program with Latuda, the company was able to bring the drug to market for the schizophrenia population more quickly than envisioned in 2010 under the banner of newly established Sunovion, followed by the drug’s approval for bipolar depression in 2013. For Loebel, the approvals marked the advent of an important new treatment option that could alleviate symptoms and improve the functioning of people suffering from serious mental health conditions marked by physical and neuropsychological comorbidities, including problems such as substance use and suicidality.

Says Loebel, “Since then, Latuda has become a very important medicine. It’s very widely used and now a core treatment for people suffering from bipolar depression. It is extremely gratifying personally, on behalf of the teams involved, and the company, to receive very positive feedback about the product and continue to see its effects on patients’ lives.” 

According to Loebel, Latuda brought him full circle-from treating patients with mental disorders with existing known agents, to then advancing an important agent that contributed considerably to the field and treatment options for those patients.

The Latuda experience also served as the springboard for Sunovion’s drug discovery and development story for the last five years. The company is now working on SEP-363856, with a novel mechanism of action, in Phase III clinical trials for schizophrenia. 

Sunovion is also conducting a Phase IIa study of SEP-363856 for the treatment of Parkinson’s disease (PD) psychosis, as well as of SEP-4199, an investigational drug for bipolar depression, in addition to other candidates in earlier phases. “Based on the results of the SEP-363856 schizophrenia Phase II study, which was recently published in NEJM, the FDA provided breakthrough status, which underscores the potential of SEP-363856 as a novel treatment for patients with schizophrenia, for whom few major advances in treatment have occurred since the 1950s,” says Loebel. He notes that the company is hard at work thinking about future indications, seeing potential for a wide range of uses in various neuropsychiatric disorders.

Sunovion’s commitment extends to other therapeutic areas of development, including respiratory and neurology conditions. Already on the market is Brovana® (arformoterol tartrate), which addresses chronic obstructive pulmonary disease (COPD), and Aptiom® (eslicarbazepine acetate), for the treatment of partial-onset seizures.

The May FDA approval of KYNMOBI (apomorphine HCI) sublingual film for the acute, intermittent treatment of OFF episodes in patients with PD, also fits in with Sunovion’s determination to uncover therapies to meet unmet needs, and better treat neuropsychiatric conditions. For example, OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. As Loebel explains, OFF episodes commonly occur later on in the course of illness for patients with PD, and are associated with a great deal of distress, disability, and impairment of quality of life. He describes that patients have trouble maintaining

Antony Loebel: bio glance; click to enlarge

normal motion and moving around, for example, standing up from a seated position, or even walking and talking. But because KYNMOBI can dissolve under the tongue, it is much easier for patients-especially those suffering from tremors or movement issues, as well as gastric absorption issues-to quickly find symptom relief. 

“We believe KYNMOBI has the potential to become the treatment of choice for patients with Parkinson’s disease who experience off episodes by quickly and easily getting them back ‘on’ anytime, so that they can take control of their day,” says Loebel.

He commends Sunovion and Sumitomo Dainippon Pharma for sticking with patients with these types of unmet needs, and especially in the central nervous system (CNS) space, an area many pharma companies have left because of the risks involved with drug development. “One of our fundamental values is to ensure that we focus on the need to serve and create value for patients at all times,” says Loebel. “Patients’ needs are at the center of what we do, and we take that seriously. Everyone at the company understands the importance of our patient-centric approach and ensuring that our day-to-day work considers and integrates the views of patients as much as possible, and that our work addresses actual real-world health needs.”

Achieving for others 

Along the path of Loebel’s career, he has authored numerous articles on the diagnosis and treatment of severe mental illness, and has distinctions including Fellow of the American Psychiatric Association and member of the American College of Neuropsychopharmacology. For his achievements in advancing new treatments for CNS disorders, Loebel received the 2015 Award for Leadership from the International Society for CNS Drug Development and the 2019 CNS Summit Leadership Award. Loebel, again, credits his work with colleagues for these achievements. 

“I have been honored to have received a number of awards for innovation in drug development in CNS, but

though they were given to me personally, I received them on behalf of teams of experts, and hardworking people who have collaborated to conduct the development programs that have led to the ultimate success of these medications,” he says. 

Though he may provide the vision and direction for the development teams, Loebel stresses that drug discovery and development is not a solitary activity. “It can’t be done by one person on their own,” he says. “What I’ve learned is that success in our industry, particularly in CNS drug discovery and development, is highly dependent on working with a wide range of teams with important expertise that must come together in an integrated way.”

Post-COVID vision

Like many pharma companies, the transition from working in centralized corporate locations to a remote, virtual workspace occurred quickly. Loebel says he was proud of the way Sunovion employees could pivot successfully, build on available digital tools and technologies to continue effective internal communication and with external stakeholders, preserve business continuity, and serve patients. He does think that the pandemic will bring permanent changes, including more flexible work arrangements. 

“This experience has been illuminating. If we can work from anywhere, that makes it feasible for us to think about recruiting and retaining employees from not only other parts of the country, but even other parts of the world,” says Loebel of a decentralized work model. “That, in turn, may make Sunovion an even more attractive place for people to work and grow their career.”

Another change? How healthcare practitioners will continue to interact with patients via telemedicine. “I think the pharmaceutical industry will need to adapt to a world where we are more dependent on digital channels of communication,” says Loebel. He believes the industry is now working to understand best practices in the dissemination of data using digital means, but there is the possibility of tailoring how this is done to the needs and preferences of individual practitioners more precisely than in the past. 

COVID aside, Loebel also sees a bright future for digital therapeutics, whether as standalones or used in conjunction with Sunovion products. “There is great potential to enhance the therapeutic value of our products as we take advantage of new ways to apply technology to healthcare needs.” This would again bring him full circle-as Sunovion embraces technology to make lives better for patients with serious medical conditions, and for their care partners, while decreasing the burden for society at the same time.

Lisa Henderson is Editor-in-Chief of Pharm Exec. She can be reached at lhenderson@mjhlifesciences.com. Follow Lisa on Twitter: @trialsonline