Respiratory trials face unique challenges: Vida Diagnostics

For a list of reasons, approximately 52% of respiratory drugs fail at Phase III and after. Susan Wood, CEO of Vida Diagnostics, spoke with Outsourcing-Pharma on some of the factors contributing to the high failure rate, as well as some of the unique ways the company is working to improve that figure.

OSP: Could you please share an overview of Vida—who you are, what you do, key specialties/ accomplishments, and what sets you apart from others in the field?​

SW: Vida is modernizing lung and respiratory care by empowering providers and biopharma companies with what we call “lung intelligence.” This includes more than 50 validated imaging-based biomarkers of lung disease that offer quantitative measures of lung health. Life sciences companies leverage these measures to accelerate time to market for new therapies; providers utilize our biomarkers to help optimize care for their patients.

Our approach is uniquely comprehensive, with analysis that addresses all major lung diseases across the care spectrum, from discovery to recovery. Additionally, we take pride in our clinical leadership and validation, with over 200 peer-reviewed papers utilizing our biomarkers.

OSP: Could you please share some of the things that distinguish respiratory trials from studies involving other conditions? What are the unique challenges of such trials?​

SW: It’s worth noting that more than half (52%) of respiratory drugs fail at phase III and beyond, making new therapies costly and time-consuming to bring to market. In fact, of all therapeutic areas, none are more expensive or time-consuming as respiratory trials. That’s because, in part, that lung disease is complex and difficult to measure, yet conventional techniques for evaluating lung function can be rather blunt.

For example, one common trial endpoint is the six-minute walk test—a measure of how far a patient can walk in six minutes. This might be a good indication of general health, but it’s not a direct measure of chronic obstructive pulmonary disease (COPD) progression in the lungs. To complement such a test, we can provide millimeter level changes in airway wall thickness, tissue densities, and do so for distinct regions of the lung. That’s why the use of imaging in these trials is growing rapidly.

Additional lung and respiratory challenges include finding the right clinical trial subjects, effectively managing massive amounts of trial data, and ensuring sites are properly trained and equipped with the tools they need to carry out a successful trial. Vida is addressing these challenges by identifying imaging-based biomarkers in the lungs that can indicate whether a patient is an especially strong candidate for a clinical study and offering a centralized cloud-based platform to ensure proper site training, data consistency, and equipment calibration. Once a site is certified by Vida, trial sponsors can use it over and over to streamline the entire trial process.

OSP: How has COVID-19 complicated the process of launching and running trials for respiratory treatments?​

SW: COVID impacted respiratory trials as it did trials in other clinical areas. As countries locked down to manage the spread of the virus many trials were put on hold and participant retention, which is always a challenge, was also exacerbated by the pandemic. As more trials adapt to remote operations, Vida is well equipped to support these distributed trials with cloud-based access and collaboration tools. 

The silver lining, however, was the spotlight the pandemic put on lung and respiratory disease, an area that has historically been underfunded in terms of research and development and investor support. With innovation rapidly underway to treat the long-term effects of COVID-19, as well as wildfires and smoking/vaping that contribute to a long list of devastating pulmonary conditions, it’s shown the world how critical our lung health is and the increasing ways it is jeopardized.

OSP: What are the respiratory ailments you feel are most in need of new therapies?​

SW: COPD, asthma, acute lower respiratory tract infections, interstitial lung disease (ILD), emphysema, and lung cancer are among the most common causes of severe illness and death worldwide and it’s clear from the data that conventional treatment and research methods are not meeting the needs of today’s patients, providers and biopharma innovators. For context, the U.S. spends roughly $50 billion in direct COPD costs and there is a 22% COPD readmission rate at hospitals. Further, up to 55% of ILD patients are initially misdiagnosed.

The control, prevention, and cure of these respiratory diseases are among the most cost-effective health interventions available, so it makes sense to invest in new therapies.

OSP: You mention that 52% of respiratory drugs fail at Phase III and after—could you please share some of the reasons why, and explain why failing at that point is especially frustrating?​

SW: It’s a complex issue and there is no single cause for this pain point, but I’ll point out three reasons we see.

First are the growing expectations of regulators. The bar is high for drug companies to show strong efficacy and safety. This requires an increase in the quantity and quality of evidence generated during clinical trials. So, if low fidelity conventional measures alone are utilized in trials—a massive number of subjects are required to show a compelling statistical signal.

When a trial requires a high number of subjects, it becomes more and more difficult for that trial to meet enrollment numbers and succeed. For this reason, we are seeing a major increase in the number of trials that choose to include precision quantitative imaging biomarkers, like the ones Vida offers. 

Second, and partially related, is the challenge of enrolling subjects. It’s difficult for physicians to stay current on the various trials that are actively recruiting along with the specific inclusion/exclusion criteria. Fortunately, data found within imaging exams can be utilized to help surface potential trial candidates and close the information gap that exists. 

Finally, sponsors are challenged by finding strong clinical trial sites that excel at providing high-quality, consistent data. Imaging for lung trials can be daunting when one considers the wide array of CT scanners, reconstruction kernels, subject breathing training, scanner calibration, data security, and so on.

Since we’ve been servicing respiratory trials for many years, we know what it takes to make all this complexity simple. With a centralized cloud-based portal at the center of our offering, we ensure our trial sites are successful. 

So, we’re chipping away at the 52% failure rate statistic with solutions that reduce the overall cost and complexity of bringing new respiratory therapies to market.

Certainly, failing late in a trial is incredibly frustrating, but we’re applying our technology to provide a valuable service of archiving data in such a way that researchers can use it retrospectively, meaning they’ll have more confidence in the data and trial candidates at the start. The ability to go back and see imaging-based biomarkers, perhaps starting from raw images, also enables researchers to pose new questions about the study without disrupting the trial.

OSP: Could you explain some of the things Vida is working on to help move the needle on respiratory trials? Feel free to talk about your imaging biomarkers, site certification, etc.​

SW: I’ve mentioned a few already, from our growing database of 50+ clinically validated imaging-based biomarkers to Vida’s clinical trial site training and certification, but we have a lot more in the works. Of note is a forthcoming web-based portal that will support end-to-end trial management and mitigate some of the risk investigators face today. 

OSP: Do you have anything to add?​

SW: At Vida, we believe that a research-to-treatment deep learning loop is needed to improve care for the millions of people living with lung disease. That’s what we have worked so hard to create and today our technology is used not only to validate new respiratory therapies but also to help match the right patient with the right therapies, based on their unique illness profile, for true precision medicine.