Aural Analytics Speech Platform Powers Clinical Trial Showing Potential Early Treatment Effect for ALS Patients Treated with Investigational Therapy
Data Powered by the Aural Analytics Speech Analytics Platform Technology Will Be Presented at the 18th Annual Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting
Aural Analytics, Inc. announced data results from a clinical trial powered by the Aural Analytics speech analytics platform technology showing a potential early treatment effect with investigational therapy reldesemtiv in patients with amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease). Patients receiving reldesemtiv had slower decline in speech motor control with respect to the placebo group. The study results will be presented at the 18th Annual Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting, which will take place October 2 – 4 in Clearwater Beach, Fla.
@AuralAnalytics presents data results from clinical trial powered by speech analytics platform technology showing a potential early treatment effect with investigational therapy in patients with ALS at #NEALS2019.
“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,” said Shira Hahn, Ph.D., vice president of analytics at Aural Analytics. “The rich data collected from the study showed a significant difference between the treatment and the placebo groups.”
In the multi-national, multi-language clinical trial study, 387 participants with ALS had complete speech samples. Treatment groups were randomly assigned to 150 mg, 300 mg, or 450 mg of reldesemtiv. Speech data was collected every two weeks over a 12-week treatment period on an iPad supplied by Aural Analytics, and in-home every week through an app downloaded on participants’ personal phones or tablets. The results showed:
- Significant differences were found in motor control change over time between the treatment groups and placebo (p = .03).
- Motor control was measured by the decline in articulatory rate throughout the task, which is an indicator of fatigue.
- Patients receiving reldesemtiv had slower decline in speech motor control with respect to the placebo group.
By analyzing vocal biomarkers (components of speech) – including phonation, velopharyngeal (soft palate) control, articulation, and speech patterns – over the duration of the trial, investigators were able to detect and measure speech changes in patients treated with reldesemtiv.
For this study, the technology enabled investigators to collect voluminous data from patients in six countries across three continents while they were at home, easing the significant burden on ALS patients and their caregivers for whom travel to clinical trial sites is difficult, if not impossible.
“Our technology is built to capture clinically-relevant changes across key physiological subsystems that matter most when validating the efficacy of a compound,” said Daniel Jones, co-founder and chief executive officer at Aural Analytics, Inc. “This work highlights the impact clinically-validated digital biomarker technology can bring to clinical trial administration.”