ObvioHealth, a global virtual research organization (VRO) is working with RedHill biopharma on the launch of a Phase II/III hybrid clinical trial. The study, which will combine creative study design and digital data capture to remotely monitor patient vitals, will explore the safety and efficacy of RedHill’s RHB-107 (upamostat).
The trial will use a combination of tools, including digital health devices, patient-centric smartphone appl, home health visits and more. RHB-107 is a novel, orally administered serine protease inhibitor with antiviral and potential tissue-protective effects which targets human cells (rather than the virus itself).
Outsourcing-Pharma spoke with Ivan Jarry, CEO of ObvioHealth; and Terry Plasse, medical director of RedHill Biopharma, about the hybrid trial.
OSP: Could you please share why remote patient monitoring is important and useful regarding COVID-19-related research?
IJ: COVID-19 patients run the risk of getting very sick over a short period of time, which is why a lot of the research to date has been conducted inside hospitals. If a patient’s symptoms are worsening – his/her oxygen saturation is decreasing for example – we need to know so we can send the patient to the hospital. The digital devices involved in this study give us this information in real time and alerts us to potential problems so we can react quickly.
It’s also important to protect clinical staff by limiting contagion of the disease. We developed a protocol with home health visits, where there is some risk to the home health nurses; however, the exposure is limited to one care provider as opposed to the many staff members who work inside a clinic.
In addition, requiring patients to travel when they are sick is burdensome for them. Together with RedHill, we designed this study with the patients in mind, allowing them to recover at home, a much more comfortable place to be when you’re sick.
By reducing the burden to patients, we can accelerate recruitment and increase our compliance and retention rates, which will ultimately provide RedHill with better data.
Finally, since this is a treatment study, RedHill needs ample data on the symptoms of the disease and time to recovery. By monitoring patients remotely, we’re receiving constant telemetric measurements of temperature, pulse ox, respiratory rate, heart rate, etc.
In a traditional study, this data would have only been collected sporadically. The more frequent measurements give us more complete data, which we average over time – this helps to address the typical heterogeneity of measurement.
OSP: Could you please tell us a little bit more about RHB-107, and why it’s especially unique compared to other COVID-19 treatments (and therapy candidates)?
TP: RHB-107 is RedHill Biopharma’s novel, potent orally administered Phase II/III-stage serine protease inhibitor, that targets a human cell factor involved in viral replication and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model and previous preclinical work demonstrated potential tissue-protective action.
RHB-107 has undergone several Phase I and Phase II studies in different indications, demonstrating its clinical safety profile in approximately 200 patients. RHB-107 is being evaluated in a Phase II/III study of patients who have symptomatic COVID-19 but do not require hospitalization.
The study is unique in a COVID-19 trial setting in its extensive use of telemetry and electronic patient-reported outcome (ePRO) data collection to monitor patients’ well-being and is based on the latest FDA guidance for symptom monitoring. The innovative use of home-based safety and efficacy monitoring technologies, together with home nursing support, enables patients to participate in the study from home with the benefit of hospital-level monitoring, enhancing patient comfort and markedly decreasing the risk of SARS-CoV-2 exposure to medical staff and other members of the public.
OSP: The wearables participants are receiving will measure temperature, respiratory and pulse rates, blood pressure, pulse oximetry, electrocardiogram (ECG) and weight. Could you please explain how these vitals are important to measure in COVID-19 patients?
TP: When testing a new drug there are always a number of standard measures that need to be taken. For diseases, such as COVID-19, some of these, such as blood oxygen saturation and respiratory rate, become significantly more important due to the nature of the disease physiology and the symptoms it causes. Moreover, this study enables us to monitor patient signs at a level previously unavailable.
OSP: Could you please outline how home-health workers will be used to aid in the collection of data in this study?
IJ: There are a total of four home health visits in this study. During these visits, home health nurses perform COVID-19 PCR swab testing and collect blood samples. They also check on the patients’ well-being, they confirm the data entered via our app is accurate, and they assess the functionality of the digital devices that are used to monitor and collect data from the patients.
The data entered from the home health nurses flows directly into our central database. Our platform delivers live monitoring dashboards where the data from different sources - whether it's ePRO, eClinRO or data from the telemetric devices - can be monitored in real time.
OSP: How did ObvioHealth and RedHill come to work together? Have your companies partnered on projects in the past?
IJ: This is our first partnership. RedHill knew a traditional study was not ideal because of the need to limit contact between healthcare providers and patients. RedHill reviewed a handful of different DCT suppliers and felt that our capabilities to remotely monitor patients using our platform of connected devices and our app, along with our clinical operations team, were the most comprehensive for their study.