Speech Vitals, software app for ALS research and care, gains FDA support

Breakthrough device status given to app monitoring progression via speech

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by Mary Chapman |

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Aural Analytics‘ speech analytics software app for amyotrophic lateral sclerosis (ALS), intended for use by researchers and doctors working in the disease, has been designated a breakthrough device by the U.S. Food and Drug Administration (FDA).

The designation is meant to speed the development and review of devices with a potential to better treat or diagnose life-threatening or chronic and debilitating conditions.

Called Speech Vitals, the ALS mobile application collects short samples of a patient’s speech, prompted by app-based tasks, to help professionals in monitoring changes, from improvements to disease progression.

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“Achieving breakthrough designation for Speech Vitals – ALS is explicit validation that the FDA sees the potential in the Speech Vitals platform to provide for more effective management of this devastating disease,” Jeremy Moore, Aural Analytics’ director of quality assurance and regulatory affairs, said in a company press release.

“We look forward to working closely with the agency to continue to develop our platform … to get it into the hands of the physicians and patients that need it the most,” Moore added.

Due to the progressive weakness in the muscles that control the mouth and vocal cords, people with ALS often experience speech problems early in their disease course. These include slow or slurred speech, hoarseness, and difficulty managing tone and pitch.

As speaking abilities tend to worsen over time, changes in speech can be noninvasive, ready markers for monitoring disease progression.

“We strive to improve patient outcomes by unlocking the valuable brain health data available in the speech signal with scientifically sound and technically viable speech analytics technology,” the company states on its homepage.

The app is reported to be user-friendly and intended for clinic or home use. But its current use may be limited to clinical trial participants as a way of helping to determine an investigative therapy’s effectiveness.

Aural Analytics reported, in a separate release, that the app was used in the Phase 2/3 study (NCT04615923) of oral pridopidine, part of the ongoing HEALEY ALS Platform Trial (NCT04297683) that is testing multiple ALS treatment candidates simultaneously.

While the pridopidine trial failed to meet its primary goal of better physical function, recently diagnosed patients with signs of rapidly progressing ALS showed benefits with treatment.

Significant gains also were observed in two speech measures — speaking rate (how fast someone talks) and articulation rate (how quickly and clearly someone sounds out each word) — across treated patients relative to those given a placebo, as were positive trends in respiratory function.

Technology used in the app currently is available on four continents and works with eight languages, Aural Analytics reported.

Speech Vitals collects a few minutes of speech from a patient engaging in tasks that gauge speech duration, precision of articulation, speaking rate, and other metrics that help to monitor motor conditions that affect speech. The app can be deployed on any device, anywhere in the world.

Aural Analytics also intends to explore its technology as a potential tool to help in diagnosing ALS. Should Speech Vitals – ALS be given regulatory approval, the company plans to apply the technology to Parkinson’s disease and other conditions affecting speech.