Vivonoetics is partnering with Great Lakes NeuroTechnologies to provide advanced respiratory assessment to the Roche FIREFISH Phase 2 clinical trial in infants with type 1 spinal muscular atrophy type 1 (SMA-1).
Vivonoetics is the developer of VivoSense data analysis and software and wearable monitoring devices that have supported research and clinical trials at hundreds of pharmaceutical, research, and academic institutions. The company’s scientists analyze physiological data collected by wearable sensors, enabling them to provide expertise at all trial stages, from initial scientific review and sensor selection to data output.
Measuring longitudinal changes in respiratory muscle function in infants and young children with SMA-1 is a critical element in the evaluation of targeted interventions. According to Vivonoetics, the accuracy of many studies of infants with SMA-1 is compromised by not having appropriate respiratory testing tools suitable for infants, resulting in inappropriate analyses.
The Roche FIREFISH clinical trial (NCT02913482) is titled “A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7034067 in Infants With Type1 Spinal Muscular Atrophy.”
It’s an open-label, multicenter clinical study to assess the safety, tolerability, properties, and effectiveness of RO7034067, an orally administered drug candidate designed to correct splicing of SMN2, the SMA “backup gene,” in infants with type 1 SMA.
The two-part study, which is currently recruiting participants, consists of a dose-finding investigation (Part 1) and a confirmatory part (Part 2) which will investigate the therapy administered orally at the maximum tolerated dose for up to 24-months.
Accurate pulmonary ventilation measurement traditionally relies on use of masks or mouthpiece devices coupled with the airway opening, which are ill-suited for monitoring infants. The Roche study will be the first large SMA-1 clinical trial to use Respiratory Inductance Plethysmography (RP) to enable investigators to noninvasively sense respiratory movements of the body systems as an alternative.
According to Vivonoetics, the measurement and analysis of precise patterns of chest and abdominal wall movements will enable objective measurements and evaluations of pulmonary function. Analysis of RP data for evaluating infant breathing is possible for trained analysts using the company’s proprietary VivoSense analysis software to observe clinically significant respiratory changes.
“We strive to advance clinical trials through the use of wearable technology,” Vivonoetics’ COO Dudley Tabakin said in a press release. “With our expertise in wearable respiratory sensors and detailed data analytics, we have developed a solution that works for monitoring infants with airway obstruction observed in SMA.”
RP sensing technology will be provided using Great Lakes NeuroTechnologies’ BioRadio wireless wearable data system that can record in real time. The collected RP data are transmitted via Bluetooth to a computer, making it available for processing and analysis by the Vivonoetics analytics team.
“Great Lakes NeuroTech is very proud to collaborate with Vivonoetics on this exciting study in SMA. This represents successful integration of wearable technology and advanced data analytics to capture infant respiration,” said Carissa Simmerman, Great Lakes NeuroTech BioRadio clinical trials manager. “We are strongly committed to using wearable and remote monitoring technology to make a positive impact on quality of life for those affected by respiratory disorders.”
VivoSense also allows clients to upload, import and store trial data on their integrated Cloud storage system, in which data are located in a remote repository and accessed through the Internet.