MONT-SAINT-GUIBERT, Belgium,
Sept. 17, 2021 /PRNewswire/
-- Tools4Patient presented data at the MDS Congress 2021 that
predicted the placebo response in Parkinson's disease (PD) in a
multi-center, multi-national clinical study. This approach – called
Placebell©™ – to mitigate the negative
impact of the placebo response is an effective tool to increase
study power of randomized clinical trials (RCTs), resulting in
increased success rates and decreased clinical trial timelines and
cost.
Tools4Patient's Parkinson's disease study extends Placebell's
success as a platform solution for multiple indications.
"Modeling the Placebo Response in Parkinson's Disease" was
presented at the International Parkinson and Movement Disorders
Society's MDS Congress 2021. Co-authors of this study include
Samuel Branders, Celine Billocq and Alvaro
Pereira (Tools4Patient); Olivier
Rascol (Centre d'Investigation Clinique, INSERM);
Gaetan Garraux (University of
Liege); Brian Berman (Department of
Neurology; VCU School of Medicine); Glenn
Stebbins and Christopher
Goetz (Department of Neurological Sciences; Rush University Medical Center).
The predictive, multivariate Placebell model is based on
patients' psychological traits and other factors associated with
the placebo response (e.g., baseline PD intensity). For this study,
94 subjects with mild to moderate PD received placebo treatment for
3 months in a blinded administration. The placebo response was
measured by: MDS-UPDRS part III (primary endpoint); MDS-UPDRS part
I, II and IV; IGAC, PGAC; PDQ-39 (PD questionnaire); ESS
(Epworth Sleep Scale); FSS (Fatigue
Severity Scale). Tools4Patient's proprietary Multidimensional
Psychological Questionnaire (MPsQ) was administered once (at
baseline) and was used to assess various psychological traits
related to the placebo response.
The placebo response is a major contributing factor to clinical
trial failures (even late-stage) in many therapeutic areas.
Tool4Patient's Placebell is an innovative predictive method that
addresses this complex challenge. Placebell combines machine
learning-based algorithms with individual patient personality data
to predict the individual placebo response in a patient before the
first dose of a drug is administered. This predictive tool improves
the success rate of clinical trials, all with no statistical or
operational risk to a study. These data in PD further the positive
results with Placebell in osteoarthritis, demonstrating consistent
and repeated reduction in data variability and improvement in
clinical trial assay sensitivity.
"The placebo response is a significant barrier to demonstrating
efficacy of experimental therapies for Parkinson's disease," says
Olivier Rascol, M.D., Ph.D.
Professor of Clinical Pharmacology at Toulouse University Hospital,
France. "This predictive model of
the placebo response in Parkinson's disease is an important step
forward in managing this issue and accelerating the delivery of
medicines to this patient population."
"The Parkinson's disease study extends Placebell's success as a
platform solution for multiple indications, including recent data
analyzed for chronic pain, OA and ophthalmology," says Dominique Demolle, Ph.D., CEO of Tools4Patient.
"We continue to partner with top pharma and biotech companies –
along with top CROs – to help reduce drug development risk related
to the placebo response using Placebell. This is part of a
portfolio of solutions being developed by Tools4Patient that
address key challenges to drug development."
About Tools4Patient
Tools4Patient, a Belgian startup company, began operation in
2014 after former colleagues of a big pharma company set out to
tackle some of the most challenging issues that prevent drugs from
reaching the marketplace. With the support of key opinion leaders
of various disciplines, in the pharmaceutical and medical world,
including renowned researchers at University
of Sydney, Toulouse, INSERM and University of Liège, the
company today offers a comprehensive set of solutions that tackle
the overall clinical research value chain, from recruitment to data
interpretation. Tools4Patient aims to accelerate patient access to
new therapies to improve patients' lives by developing and
commercializing methods and data analysis solutions focused on the
unique patient characteristics that influence their response to
treatment. The company's first technology is
Placebell©™, which
characterizes the placebo response of patients. Tools4Patient is
financed by private investors and funds, including Sambrinvest and
Innovation Fund. Learn more at www.tools4patient.com
CONTACT: Patty Pologruto,
patty@altitudemarketing.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/tools4patient-develops-predictive-model-of-the-placebo-response-in-parkinsons-disease-301379160.html
SOURCE Tools4Patient