Speech analysis tech for ALS gets FDA breakthrough tag

Software that can be used to monitor patients with neurodegenerative disorder amyotrophic lateral sclerosis (ALS) using their voice patterns has been granted breakthrough status by the FDA, which could speed up its journey to approval.

Aural Analytics’ Speech Vitals-ALS app is used to collect and analyse speech recordings in ALS patients – either in clinics or their own homes – to help neurologists track how quickly their disease is progressing.

It is also being used to gauge whether drug treatments are having an impact on ALS in clinical trials, and in time Aural Analytics is hoping it could be used to diagnose patients with the disease.

One of the hallmarks of ALS is damage to motor neurons in the bulbar region of the brain, which can have a devastating impact on patients’ ability to communicate, but it is hard to pick up in the early stages using conventional ALS rating scales.

Speech Vitals-ALS has been developed to pick up early deterioration in speech patterns, such as articulatory precision (AP) and speaking rate (SR) that could serve as ‘vocal biomarkers’, providing early detection and tracking of ALS symptoms from just a few minutes of speech samples taken from patients using app-based tasks.

The vocal biomarkers could also be used to predict declines in other bodily functions affected by ALS, like swallowing and breathing.

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

The company is currently trying to secure regulatory approval of the software under the de novo clearance pathway for medical devices – used for products which have no similar devices on the market with which the company can claim substantial equivalence.

Speech Vitals-ALS was recently used in a placebo-controlled clinical trial evaluating Prilenia Therapeutics’ sigma-1 receptor antagonist pridopidine in patients with ALS.

While the study wasn’t able to show a statistically significant impact on ALS progression, the speech analytics software did suggest that prilopidine was slowing the decline in several markers related to speech and bulbar function, including AP, SR, sustained phonation, and articulation rate.

The pridopidine study was being conducted as part of the HEALEY ALS Platform trial, which has been designed to accelerate the development of treatments by testing multiple drugs for individuals with ALS.

Aural Analytics also intends to develop its Speech Vitals software for other neurodegenerative disorders, including Parkinson’s disease.