SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Aural Analytics, Inc. today 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.
“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.”
Gabriela Stegmann, Ph.D., Aural Analytics data scientist, adjunct professor at Arizona State University and adjunct professor at Keiser University, will present poster #26 “Using voice analysis to track ALS progress in clinical trials with a mobile app” in a poster session on Thurs., Oct. 3, 2019 from 4:00 – 6:00 p.m., ET in the Opal Sands Foyer at the Opal Sands Resort. Copies of the poster will be available upon request at the meeting.
The Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) was founded in 1995 with nine academic clinical centers in the New England area and has grown to 128 research centers committed to performing research in amyotrophic lateral sclerosis (ALS) and motor neuron disease (MND). The NEALS mission is to translate scientific advances into new treatments for people with ALS and MND as rapidly as possible. NEALS functions as an academic research consortium, a contracted research organization and a resource tool for ALS community.
The 18th Annual NEALS Meeting will host over 400 NEALS members, foundation partners, company representatives and ALS researchers. The 2019 NEALS Meeting will feature research updates, member presentations, abstract poster session, a Science Symposium focused on TDP-43, and numerous networking opportunities. For more information, please visit: https://www.neals.org.
About The Aural Analytics Technology Platform
Aural Analytics has built a model-driven, transparent speech analytics engine based on decades of expertise in speech neuroscience that has been clinically validated to the highest standard in several disease indications. The cloud-based software platform combines beautiful mobile design with speech signal processing and cognitive linguistic analysis together into one powerful set of APIs that are easily extensible across the continuum of care. The platform is disease, location, language and device agnostic and has been deployed in eight languages and on four continents. Users can leave samples from anywhere in the world, any time.
The platform uses speech to extract subtle, but clinically relevant, measures by tapping directly into various nervous system functions. The mobile-first, patient-centric product suite is easy to use, low cost and analytics are available in real-time. The analysis quantifies aspects of speech known to change with disease including, but not limited to, motor control, respiratory support and function and all aspects of cognitive linguistics. Aural Analytics’ solutions have been used extensively in interventional clinical trials, observational research studies and several clinical and consumer settings.
Aural Analytics, Inc. is a privately held digital health company developing the world’s most advanced speech analytics platform, built on a foundation of 25 years of speech neuroscience research and data. The Company’s platform technology is based on pioneering research from Arizona State University and reinforced by multiple high-caliber peer-reviewed publications. Winners of the 2017 Global SCRIP Award for Best Technology in Clinical Trials, Aural Analytics’ first-to-market technology platform powers health applications all over the world. The Company maintains headquarters in Scottsdale, Ariz. For more information, please visit auralanalytics.com or follow Aural Analytics on Twitter, LinkedIn, Medium and Facebook.