Use of reldesemtiv in a clinical trial in amyotrophic lateral sclerosis (ALS) patients led to a slower decline in muscle control needed for speech relative to placebo, a study reports.
The trial used Aural Analytics’ proprietary speech analytics platform technology to evaluate this motor function in a large group of enrolled patients.
This finding was presented by Gabriela Stegmann, PhD, a data scientist with Aural Analytics and an adjunct professor at Arizona State University and Keiser University, in the poster “Using voice analysis to track ALS progress in clinical trials with a mobile app,” at the 18th Annual Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting held Oct. 2–4 in Florida.
Reldesemtiv is an investigational, next-generation fast skeletal muscle troponin activator (FSTA) being developed by Cytokinetics in collaboration with Astellas. It is designed to ease muscle contraction with minimal nerve stimulation to slow the decline of muscle function associated with ALS.
FORTITUDE-ALS was a randomized, double-blind, placebo-controlled, Phase 2 trial (NCT03160898) that assessed the effects of reldesemtiv on respiratory and skeletal muscles in people with ALS. A total of 458 patients at clinical centers across the U.S., Canada, Europe, and Australia were randomly assigned to either reldesemtiv (at a dose of 150, 300 or 450 mg) or a placebo, taken orally twice a day for 12 weeks.
Aural Analytics’ speech analytics platform technology was used to evaluate speech data from 387 study participants.
Speech samples were collected every two weeks over the treatment period using an iPad supplied by the company, and at-home once-a-week through an app installed on the patients’ personal phones or tablets.
Speech data enabled investigators to analyze and compare between treatment and placebo groups several components of speech (which they called vocal markers), such as phonation, word articulation, and speech patterns, throughout the trial.
Findings showed alterations in speech motor control, measured by a decline in patients’ ability to articulate words, from the study’s start through to its end in both patient groups.
However, patients given reldesemtiv had a slower decline in speech motor control compared to those given a placebo.
“Current clinical ratings for ALS lack sensitivity to small changes and rely on the subjective impressions of the rater. To address these challenges, we deployed our digital biomarker platform to collect data on a granular level and provide objective, clinically-relevant measures of speech change for speech collected,” Shira Hahn, PhD, vice president of analytics at Aural Analytics, said in a press release.
“The rich data collected from the study showed a significant difference between the treatment and the placebo groups,” Hahn said.
“Our technology is built to capture clinically-relevant changes across key physiological subsystems that matter most when validating the efficacy of a compound,” Daniel Jones, co-founder and chief executive officer at Aural Analytics, said. “This work highlights the impact clinically-validated digital biomarker technology can bring to clinical trial administration.”