News & Resources

Overview Possible treatments COVID-19 Aptitude Health 2020

Overview of potential treatments for COVID-19

The recently authorized emergency use of remdesivir by the US Food and Drug Administration (FDA) for patients hospitalized with severe confirmed or suspected COVID-19 represents an important step forward for reducing morbidity during the pandemic. However, while remdesivir was able to significantly accelerate recovery in the double-blind placebo-controlled NIAID ACTT-1 trial, approximately 8% of treated patients still succumbed to their disease. Further studies are needed to determine the optimal use of remdesivir. In addition, there remains an urgent need for additional treatments. A recent JAMA review paper summarized multiple ongoing studies in this area, providing additional hope in the fight against life-threatening COVID-19 disease.

As an RNA virus, SARS-CoV-2 is inherently susceptible to agents that target RNA replication, such as nucleoside analogues. Remdesivir falls into this category and causes chain termination during RNA-dependent RNA replication. Agents with similar mechanisms of action, ribavirin and favipiravir, are also currently being evaluated against COVID-19. As with remdesivir, favipiravir demonstrated promising preclinical activity against other RNA viruses (influenza and Ebola). Favipiravir is currently available in Japan for the treatment of influenza, but is not available in the United States. Another targetable stage of the virus life cycle is the cleavage of viral polypeptides into nonstructural proteins by 3-chymotrypsin-like protease. Similar to its activity against the human immunodeficiency viruses, the lopinavir-ritonavir protease inhibitor combination has shown in vitro activity against coronaviruses and some positive outcomes in very early clinical experiences.

SARS-CoV-2 enters cells through an interaction between the viral S protein and the cellular ACE-2 receptor, after which it fuses with the cell membrane and forms an endosome. Umifenovir targets the S protein–ACE-2 interaction, and camostat mesylate inhibits a host serine protease, TMPRSS2, that is important for the membrane fusion event. The clinical efficacy of these agents remains unclear. Other agents that could theoretically block viral entry into the cells are chloroquine and hydroxychloroquine, which also induce attenuation of cytokine production and inhibition of autophagy and lysosomal activity in infected cells. Although early clinical testing suggested that these agents were active in COVID-19, the studies were small, and safety data were limited. More recently, a randomized double-blind phase IIb trial in Brazil failed to reach its primary endpoint of reduced mortality with high-dose vs low-dose chloroquine, with the high dose demonstrating higher rates of cardiotoxicity and more deaths than the lower-dose arm.

In addition to antimicrobials, agents that reduce the inflammatory collateral damage of COVID-19 are being investigated. Corticosteroids can be used to decrease lung inflammation that leads to acute lung injury and acute respiratory distress syndrome (ARDS). However, their routine use in patients with COVID-19 is not recommended due to their potential adverse effects, such as delayed viral clearance and increased risk of secondary infection. Tocilizumab, a monoclonal antibody against interleukin (IL)-6, can reduce IL-6–mediated organ damage in the lungs and other organs of COVID-19 patients. Several clinical trials of tocilizumab, alone or in combination, are currently ongoing in China (NCT04310228, ChiCTR200002976), and Italy (EudraCT number: 2020-001110-38). The IL-6 receptor antagonist sarilumab is being studied in a multicenter, double-blind, phase II/III trial for hospitalized patients with severe COVID-19 (NCT04315298).

An emerging strategy to fight COVID-19 is the use of antibodies from recovered patients (“convalescent sera”) to help clear the virus in patients with active infections. Such passive immunity may be an important stopgap measure until vaccines are developed that can prevent further spread of SARS-CoV-2.

High Altitude: The COVID-19 pandemic has had a major impact on oncology, with fewer screening visits, delayed surgeries, and deferments in myelosuppressive chemotherapy regimens. In addition to ongoing containment efforts and investigations of vaccine strategies, the development of more-effective treatments for COVID-19 are essential for a return to normalcy. Prior reports have shown that cancer patients are at increased risk for contracting SARS-CoV-2 and for contracting severe COVID-19. As the number of clinical studies is increasing rapidly, oncologists should consider enrolling their COVID-19 patients in these trials when eligible. Oncologists at academic centers could become important partners in clinical trial recruitment for the investigational COVID-19 therapies.

Ground Level: At present there are no proven effective therapies that can be used to treat COVID-19 patients. However, different studies and investigations are ongoing, and the clinical results will certainly provide more clarity on the best treatment approach. While waiting for a possible therapy, patients will continue to receive the best supportive care, from symptom management to full intensive-care support when needed. The development of a vaccine will likely represent the real solution to win against SARS-CoV-2 virus.

Therapeutic Area

Archives

Matthew Gordon

VP, Real-World Evidence
Matthew has more than 25 years of experience in real-world evidence and observational, non-interventional research. He has led studies across the full life cycle—from startup through publication—supporting objectives that range from understanding a disease’s natural history to fulfilling global safety surveillance requirements. Matthew brings deep expertise in orphan disease programs, having overseen more than 25 long-term, global initiatives, as well as in disease and product registries, prospective pharmacoeconomic studies, and systematic literature reviews. Matthew leads the RWE Registries team, responsible for building the business and team. Prior to joining Aptitude Health, he held senior leadership roles at Parexel, Worldwide Clinical Trials, inVentiv Health Clinical, Quintiles Outcome, and ICON Clinical Research. Matthew holds a BA in sociology from Boston University, is a long-standing member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and is a frequent speaker at ISPOR, the Center for Business Intelligence, and related industry conferences.

Gerald Stanvitch, PhD

VP, Scientific Content

Cate Browning, PhD

VP, Global Medical Affairs

Erin Zingales Rau

VP, Account Services

Kelly Kocor

VP, People & Culture
Kelly leads both the human resources and talent acquisition teams, ensuring that Aptitude Health attracts, retains, and develops top personnel to drive our continued success. With over 17 years of experience transforming global HR initiatives, Kelly is an expert in harmonizing HR policies and fostering a culture of engagement and partnership. She is committed to partnering with all areas of the business to ensure full regulatory compliance and delivering value-added services to our organization and its people. Kelly is passionate about developing and implementing HR strategies that help support our employees’ professional and personal growth. She is dedicated to fostering a culture that encourages innovation, collaboration, and inclusivity, helping Aptitude Health continue to be a great place to work.

Bart Zygmond

VP, Finance
Bart brings a wealth of experience to the organization, having worked in the life sciences, pharmaceuticals, manufacturing, and service industries. With his expertise in financial reporting, US GAAP, SOX, cash flow modeling, and financial analysis, he plays a crucial role in the company’s financial management and strategy. Prior to joining Aptitude Health as VP, Finance, Bart held several controller positions: at Q2 Solutions, he oversaw the global finance team and financial operations, ensuring the accurate and timely financial reporting of the company. He also held controller positions at Domtar Inc and Veristat.

Eugene Vissers, MD

Senior VP, Global Scientific Content
Eugene is a seasoned medical doctor with over 20 years of international experience in pharma, consultancy, and agency environments. Eugene leads the US team of dedicated experts responsible for developing high-quality medical content. Prior to joining Aptitude Health, Eugene served as medical director at Ipsen and AstraZeneca. With both his medical degree and an MBA, Eugene brings a unique perspective to his role. His clinical background, combined with his business acumen, allows him to develop innovative strategies that drive results. Under Eugene’s leadership, the medical content team delivers scientific information of the highest quality, providing valuable insights to our clients around the world.

Adrian Barfield

VP, US Business Development

Kelley Hernandez

Executive VP, US Business Development
Kelley has over 18 years of experience in the oncology space. Kelley joined Aptitude Health after working with Cardinal Health, where she was part of the Healthcare and Analytics Division, and finished her tenure there with VitalSource™ (GPO division). As the leader of the strategic business development team for the US, Kelley brings a wealth of expertise to the organization. Her experience in the healthcare industry, combined with her ability to identify and capitalize on new business opportunities, is invaluable in driving the company’s growth and success. Kelley’s dedication to building strong relationships with life science partners is a testament to her commitment to delivering exceptional value to the healthcare industry.

Adam Sinensky, MBA

Chief Technology Officer

Adam has over 20 years of experience in the healthcare industry and an MBA in healthcare management. After 10 years as a strategy consultant to life science companies, Adam has spent the last decade as a product and strategy leader focused on bringing technology products to market across the payor, provider, and life sciences segments. By combining his business acumen and experience working directly with software developers, engineers, and data scientists, Adam has successfully led numerous product launches and enhancements from ideation to development and go-to-market initiatives. His product and change management expertise has led organizational shifts from services to technology at companies such as Change Healthcare and Datavant/Ciox. At Aptitude Health, Adam is responsible for growing our portfolio of product offerings by leveraging real-world data and artificial intelligence with our existing solutions and industry-leading Axess Network of healthcare providers. He also oversees our IT and cybersecurity teams.

Stefanie Daniels

Chief Commercial Officer

Stefanie is a seasoned healthcare executive with over 20 years of experience in oncology. She brings a wealth of knowledge and expertise to the organization. Stefanie joined Aptitude Health after spending over a decade as a senior director at Physicians’ Education Resource, an oncology CME vendor. During her tenure, she led and managed teams responsible for grant development/acquisition, program creation/execution, and faculty management. Stefanie’s deep understanding of the oncology industry and her ability to lead teams through complex projects make her a vital part of the organization’s success. Her dedication to providing high-quality solutions to our life science partners is a testament to her commitment to improving cancer patient care.

Jason Cash

Chief Financial Officer

Jason is an accomplished finance professional with over 20 years of experience in the pharmaceutical services industry. Throughout his career, he has demonstrated a keen ability to navigate high-growth organizations, delivering exceptional results. Before joining Aptitude Health, Jason served as the CFO of Veristat International, a global contract research organization. In this role, he led the financial strategy and played a pivotal role in driving the company’s growth and success. Jason’s wealth of experience and expertise in financial management make him an essential member of the leadership team. His strategic thinking and ability to drive results are highly respected within the industry.

Jez Moulding

Chief Executive Officer
Jez is a seasoned leader with over 20 years of experience in general management and regional president roles. He has a proven track record of success in the healthcare industry, having worked in the US, Japan, Australia, Korea, South Africa, France, and the UK for Sanofi, where he supported the launch of 10 new drugs across various therapeutic areas. As chief commercial officer at UDG Healthcare and EVP at Ashfield, Jez demonstrated his expertise in developing and implementing successful business strategies. He joined Aptitude Health from Pharmaspectra, an IQVIA business, where he served as CEO since 2018. Jez’s extensive experience in the pharmaceutical industry and his leadership skills make him an invaluable asset to the organization.