NEW YORK - March 2, 2021 - ObvioHealth, a global virtual research organization or VRO, today announced the launch of a hybrid clinical trial for the treatment of COVID-19, using an innovative study design with digital data capture to remotely monitor patient vitals. This U.S. Phase 2/3 study will examine the safety and efficacy of RedHill Biopharma’s (Nasdaq: RDHL) RHB-107 (upamostat), using ObvioHealth’s clinical trial ecosystem, including digital devices, a patient-centric smartphone application and home healthcare visits.
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 and is expected to be effective against new viral strains. The two-part randomized, double-blind, placebo-controlled hybrid U.S. Phase 2/3 study is enrolling more than 300 patients with symptomatic COVID-19, who do not require hospital care, to evaluate the safety and effectiveness of RHB-107. Patients will be sent home with RHB-107 and five 510(k)-cleared devices to begin treatment. ObvioHealth’s platform is collecting both telemetric and patient-reported information; biomarkers continuously gathered from the devices will include patients’ temperature, respiratory and pulse rates, blood pressure, pulse oximetry, electrocardiogram(ECG) and weight.
“Many previous COVID-19 treatment studies have focused on intravenous medications for hospitalized patients. However, the majority of patients are battling the virus at home. The ability to treat patients early in the course of the COVID-19 disease, with an oral therapy that shows promise against emerging viral variants and is designed to be used outside the hospital, has the potential to be a game-changer in managing this disease,” said Dr. Terry Plasse, Medical Director for RedHill Biopharma. “Until recently, it was assumed that patients needed to travel to clinical sites for assessments of vital signs. However, inroads in the development of accurate and 510(k)-cleared medical devices for in-home use enable patients in clinical trials to do much of this from home.”
A recent study evaluating RHB-107’s antiviral activity in an in vitro model of human lung bronchial tissue showed potent inhibition of SARS-CoV-2 viral replication. Its combined antiviral and potential tissue-protective action make it a strong candidate for evaluation as a treatment for COVID-19 infections. Home healthcare nurses will make in-home visits to check-in on patients, collect blood samples for certain laboratory parameters, perform virus PCR swabs at home, and oversee certain patient-reported data capture, using devices provided to participants at home. This combined level of medical monitoring allows the study team to intervene quickly if a patient experiences an adverse event.
“Clinical studies involving COVID-19 patients introduce significant risks, requiring constant monitoring and careful practices to avoid exposure to the virus. This innovative trial allows participants to remain quarantined during treatment while remotely providing valuable data to researchers, reducing risk of spread,” says Ivan Jarry, CEO of ObvioHealth. “The unique needs brought on by the pandemic have opened up a world of opportunity for more convenient capture of real-world data and we anticipate growing interest in these more comprehensive remote clinical trials due to their efficiency and ease for participants.”
ObvioHealth is an end-to-end Virtual Research Organization (VRO) that delivers better data to sponsors and an easier clinical trial experience for participants. The company developed and launched the first patient-centric app, downloadable on smartphones enabling people to participate in clinical trials from the comfort of their homes. In the 3 years since launch, the company has been awarded 40 studies from 22 blue chip clients, implemented in 28 countries, in 14 different therapeutic areas.
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults [i], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults [ii], and Aemcolo® for the treatment of travelers’ diarrhea in adults [iii]. RedHill’s key clinical late-stage development programs include: (i) RHB-204,with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria(NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.
[i]Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
[ii]Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.