- Combining BIOCORP’s pen injector add-on Mallya® with AARDEX®
Group’s Software to improve adherence to medication in a Hybrid
Phase IV Diabetes Study
Regulatory News:
BIOCORP (FR0012788065 – ALCOR / Eligible PEA‐PME) (Paris:ALCOR),
a French company specialized in the design, development, and
manufacturing of innovative medical devices, and Belgium-based
AARDEX GROUP, the leader in tools for measuring and managing
adherence to medication in clinical trials are proud to announce
one of their first major joint initiatives that will come live in
the upcoming months. Both companies today announced they have been
recruited by Trials@Home to take part in a Phase IV study called
RADIAL. Trials@Home is a center of excellence for Decentralized
Clinical Trials (DCTs), whose members include notably Sanofi,
J&J, Pfizer.
They will team up with Sanofi, a global leader in healthcare, to
create a digital solution for optimized insulin management, 100
years after the first insulin injection in 1922.
Bernard Vrijens, CEO & Scientific Lead at AARDEX Group,
comments: “Our digital medication adherence tool, MEMS AS®, offers
a powerful suite of tools to measure and manage adherence to
medication. This project is an opportunity to leverage our
extensive practical experience in diabetes, including our
recognized scientific leadership in medication adherence to improve
patient outcomes. We are also delighted to be progressing our
strategic partnership with BIOCORP.”
The Phase IV RADIAL study will see BIOCORP’s Mallya pen injector
add-on collect data from Sanofi’s Solostar® insulin pens. This will
then be integrated with AARDEX Group’s MEMS AS® (medication
adherence software) to provide an optimal understanding of patient
behaviors during the course of the study.
The RADIAL study aims to include around 600 patients with Type 2
Diabetes across 63 sites in six countries. Of those, 150 will be
site-based, 150 will be hybrid and up to 300 will be participating
fully remotely.
Eric Dessertenne, CEO at BIOCORP, says: “Mallya is a smart dose
monitoring solution for insulin pen injectors offering a seamless
patient experience with automatic data collection. Secured
real-time data is then transferred securely via Bluetooth allowing
end-to-end validated medication data adherence and processing with
MEMS AS® and Trials@Home’s Clinpal digital platform. This project
is an opportunity to create evidence of the user benefits and
evaluate the clinical benefits of our solution within a real-world
decentralized clinical trial setting.”
Improving medication adherence for patients with Type 2 Diabetes
is crucial to improving outcomes. Non-adherence has a direct causal
association with hospitalization and death.
Sanofi will contribute Toujeo® (insulin glargine 300 unis/mL) as
the medicinal product to be used in RADIAL, Trials@Home’s EU
proof-of-concept study.
Anastasia Ukhova, Head of Medical Digital Healthcare General
Medicine, notes: “Bringing Toujeo® to the consortium and today
Mallya cap with AARDEX MEMS AS® technology offers a unique
opportunity to build evidence on the way that innovation in
connectivity contributes to the improvement of diabetes
management.”
Trials@Home projects are funded by the Innovative Medicines
Initiative[2] Joint Undertaking (H2020-JTI-IMI2) – a public-private
partnership between the EU and the European pharmaceutical industry
body EFPIA.
The aim is to reshape clinical trial design, conduct, and
operations, by developing and piloting standards, recommendations,
and tools for the definition and operationalization of DCTs in
Europe.
Speaking about the project, Gary Friedman (Pfizer representative
on the Trials@Home project) added “The AARDEX and BIOCORP teams are
outstanding collaborators, who anticipate the nuances of
interventional decentralized clinical trials. They go to great
lengths to provide the Trials@Home consortium with technology that
is the sine qua non for study participants requiring precise
insulin dosing and compliance monitoring.”
Philipp Bordes (Sanofi representative on the Trials@Home
project) emphasized “Monitoring medication adherence in remote
patient settings is a pivotal piece of DCT design and is key to
supporting both our patients’ safety and optimal health throughout
the Trials@Home RADIAL study. The use of innovative, connected
digital health technologies such as the Mallya device and AARDEX AS
application play a key part in the optimization and acceptability
of DCTs as the DCT becomes more familiar across the industry”.
ABOUT AARDEX
AARDEX Group is the global leader in digital solutions to
measure and manage medication adherence. With operations in
Belgium, Switzerland, and the U.S., AARDEX develops and markets
digital solutions for adherence-enhancing strategies in clinical
trials, research settings, and professional healthcare systems.
AARDEX is the central actor of a complete ecosystem that combines
its MEMS Adherence Software with a wide range of smart packages and
devices that measure patient adherence across all routes of drug
administration. AARDEX’s vision is to continuously innovate in
data-driven medication adherence solutions to enhance digital
therapeutics and patient empowerment. www.aardexgroup.com
ABOUT TRIALS@HOME
Trials@Home, Centre of Excellence for Decentralized Clinical
Trials, is working to reshape clinical trial design, conduct and
operations, by developing and piloting standards, recommendations
and tools for the definition and operationalisation of
Decentralised clinical trials (DCTs) in Europe. The consortium
follows a co-creative multi-stakeholder approach where academic
partners, Small and Medium-sized Enterprises (SMEs), private
foundations, and EFPIA partners will work together with other
stakeholders from across the medical, technological, regulatory,
ethical and social aspects of DCTs. For more information, please
visit www.trialsathome.com
ABOUT BIOCORP
Recognized for its expertise in the development and manufacture
of medical devices and delivery systems, BIOCORP has today acquired
a leading position in the connected medical device market thanks to
Mallya. This smart sensor for insulin injection pens allows
reliable monitoring of injected doses and thus offers better
compliance in the treatment of patients with diabetes. Available
for sale from 2020, Mallya spearheads BIOCORP's product portfolio
of innovative connected solutions. The company has 70 employees.
BIOCORP is listed on Euronext since July 2015 (FR0012788065 –
ALCOR).
For more information, please visit www.biocorpsys.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20220721005736/en/
BIOCORP Jacques Gardette Chairman of the Board
investisseurs@biocorp.fr
Éric Dessertenne Chief Executive Officer
Marketing & Communication Director Sylvaine Dessard
rp@biocorp.fr + 33 (0)6 88 69 72 85
ULYSSE COMMUNICATION Bruno ARABIAN
barabian@ulysse-communication.com +33 (0)6 87 88 46 26
Nicolas DANIELS ndaniels@ulysse-communication.com +33 (0)6 63 66
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