NEW YORK, March 2, 2021 /PRNewswire/ -- 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."
About ObvioHealth
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 near 40 studies from
22 blue chip clients, implemented in 28 countries, in 14
different therapeutic areas.
For more information, visit https://www.obviohealth.com.
About RedHill
Biopharma
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
adultsi, Talicia® for the
treatment of Helicobacter pylori (H. pylori) infection in
adultsii, and Aemcolo® for
the treatment of travelers' diarrhea in
adultsiii. 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 /
https://twitter.com/RedHillBio.
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.
iii Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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SOURCE ObvioHealth