CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:
Voluntis (Paris:VTX), a digital biotech specialized in digital therapeutics, has announced the extension of its collaboration with AstraZeneca (NYSE: AZN) in the field of oncology. As part of the renewed agreement, the partners will implement a new phase of clinical evaluation of their digital therapeutic designed to support platinum resistant ovarian cancer patients treated with a combination of Cediranib plus Olaparib.
The eCO (eCediranib/Olaparib) solution will be tested in the GY005 randomized phase III clinical trial sponsored by the National Cancer Institute (NCI), which will evaluate if the digital therapeutic can complement treatment by determining whether it enables better management of side effects and thereby improves patient outcomes. Women and their clinicians will be given eCO in conjunction with their Cediranib and Olaparib treatment to help manage symptoms of hypertension and diarrhea sometimes associated with their therapy to enable them to stay longer on treatment. Patients will access eCO through a smartphone app in which they can record their symptoms to receive real-time recommendations. Clinicians will be able to use a corresponding web portal to track their patient population remotely and adjust symptom management plans as necessary.
“We are delighted to build upon the promising results of our first clinical trial, begun in 2015, and take our innovative partnership with AstraZeneca one step further to study the impact of our eCO solution on a larger scale, using our state-of-the-art Theraxium platform,” said Pierre Leurent, CEO of Voluntis. “Digital therapeutics, like eCO, are at the forefront of a new generation of digital solutions, developed in conjunction with medications as early as Phase II/III trials. Through this new phase of our collaboration, we look forward to providing access to this solution to more patients and, hopefully, help them enjoy a better quality of life and treatment outcome.”
Through the extended agreement, the eCO solution will also be migrated to Theraxium Oncology, Voluntis’ new platform for digital therapeutics in oncology announced earlier this year.
eCO (eCediranib/Olaparib) is a digital therapeutic for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of Cediranib plus Olaparib. Voluntis developed the service in close clinical collaboration with AstraZeneca and the National Cancer Institute (NCI) beginning in 2015. Initial results communicated at ESMO 2017 with the NCI confirmed high adherence, usability and satisfaction. In this clinical evaluation, eCO successfully supported remote monitoring of hypertension and diarrhea events for sixteen women with advanced ovarian cancer treated with a combination of Cediranib and Olaparib (JCO Clinical Cancer Informatics 2018). The women self-reported a total of 98.2% of expected home blood pressure values using a Bluetooth connected blood pressure cuff in 94.2% of instances. For diarrhea, thirteen patients reported 33 entries, none of which advanced past grade 2. Patients reported overall high usability (ease of learning and ease of use) and satisfaction with eCO, especially feeling closely monitored, more connected to their health care team and greater involvement in their own self-care.
Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team that so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real-time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics. These include Insulia® and Diabeo® in diabetes as well as eCO and ZEMY in oncology. Voluntis has long-standing partnerships with leading life science companies such as Roche, AstraZeneca, Sanofi and Onduo. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance.
Diabeo® is a registered trademark of Sanofi. Insulia® is a registered trademark of Voluntis.
For further information: http://www.voluntis.com