Aural Analytics, Inc., a leader in clinical-grade speech analytics, announced that its speech analytics platform facilitated differentiation and provided critical insights into the effectiveness of Pridopidine in clinical trials. This is the first time that a speech-based digital biomarker has suggested efficacy as a novel therapeutic for a neurological condition in a large-scale pre-registered interventional trial. The results represent an exciting opportunity for a speech-based digital biomarker to aid precision medicine and sets the stage to approach the FDA, for the first time ever, to include a digital primary endpoint for a neurological condition in a phase III clinical trial.
Pridopidine is a highly selective sigma-1 receptor (S1R) agonist developed by Prilenia Therapeutics for the treatment of neurodegenerative disorders. S1R regulates cellular pathways that are commonly impaired in neurodegeneration, including those implicated in bulbar and speech function in people living with ALS. The Pridopidine Trial was being conducted as part of The HEALEY ALS Platform trial, which was designed to accelerate the development of treatments by testing multiple drugs for individuals with ALS. Testing Pridopidine was Regimen D, an informative Phase II study.
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A potentially important finding in the Regimen D results released yesterday by The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital (MGH) and the Northeast ALS (NEALS) Consortium was the slowing of decline of voice characteristics in adults taking Pridopidine versus adults taking placebo. While a general measure of overall function did not meet the criterion for success, Aural Analytics’s measures, selected because of the mechanism of action of the drug, provided evidence that the drug preserves speech and bulbar function in patients.
The speech-motor module of Aural Analytics’s clinical-grade speech analytics platform, Speech Vitals, was used to measure specific metrics of an individual’s speech via a smartphone app that regularly captured speech from participants. Participants taking Pridopidine demonstrated slowing of decline in speech production attributes, including sustained phonation, speaking rate, articulation rate, and articulatory precision compared to study participants taking placebo. Additionally, slower decline was noted for speaking rate and articulation rate for participants who were in an early stage of the disease.
SOURCE: Businesswire