Aural Analytics, Inc., the industry leader in speech neuroscience and speech analytics technologies, announced today the initiation of a multi-product pivotal study to demonstrate the safety and efficacy of its speech-based tools for measuring pulmonary function and speech motor function in amyotrophic lateral sclerosis (ALS). The company anticipates submitting the results of this multi-site, multi-language, 280 participant, prospective, blinded study to the U.S. Food and Drug Administration (FDA) in late 2021. The study, conducted as part of the Target ALS Diagnosis Initiative, is one of several pivotal studies Aural Analytics is set to kick off in 2021 as it expands its suite of clinical-grade speech-based digital tools.
The Aural Analytics VCP™ software tool enables on-demand, real-time objective evaluation of pulmonary function by predicting forced vital capacity (FVC) and forced expiratory volume (FEV1) without the need for specialized hardware in-clinic and at-home. These measurements are commonly used in the assessment of airflow obstruction (COPD, asthma) and restrictive lung disease (ALS). The VCP™ software is currently being used as one approach to screen for eligibility in the Healey Center ALS platform trial at Massachusetts General Hospital. Aural Analytics will also use the study to further demonstrate the safety and efficacy of its speech-based assessment software that enables on-demand, real-time objective monitoring of symptoms and progression in diseases known to impact bulbar function (speech and swallowing).
“Aural Analytics is enabling clinical-grade speech analytics in areas of critical unmet patient and clinical need. This study will be the basis of multiple regulatory submissions for products that have broad clinical utility and commercial pathways,” said Daniel Jones, co-founder and CEO of Aural Analytics. “We continue to work closely with regulators at the FDA and key stakeholders across the healthcare industry to ensure safe, reliable, repeatable and transparent speech-based tools are brought to market.”
More about the Aural Analytics VCP™ Software in ALS
Respiratory failure is the leading cause of death in patients with ALS. As a result, regular assessment of respiratory function is the standard of care. People with ALS often have problems achieving valid measures on standard in-clinic or at-home spirometers. Lip weakness can prevent creation of a tight seal around the spirometer and some with ALS experience an involuntary slamming shut of their vocal cords when they exhale forcefully. Spirometers often induce bouts of coughing which, given the COVID-19 pandemic, has made it increasingly difficult to objectively measure respiratory function in-clinic. “Our VCP software is designed to tap into both inspiratory and expiratory muscle strength, without requiring lip strength, and with far less chance of inducing laryngospasm or coughing,” said Dr. Julie Liss, co-founder and chief clinical officer at Aural Analytics. “Our application enables a patient to easily deliver pulmonary function data, remotely, with just a few short tasks. The outcome measures are clinically relevant, interpretable, reliable and highly repeatable.”
More about the Aural Analytics Speech Motor Control Software
Functional rating scales have been used historically to capture the impact of disease on a person’s daily life. These rating scales are often coarse, subjective, and can miss key information about how a patient is doing. “We have found that the information we extract from speech samples tracks well with a number of functional rating scales for different diseases,” said Dr. Liss. “Yet, more importantly, our speech metrics can detect changes in disease before they have functional consequences and in a far more frequent, objective way. We believe this tool will provide an opportunity for greater precision in clinical management.”
The Aural Analytics VCP and speech motor assessment applications further add to the company’s technology suite which includes mobile applications currently available for use in clinical research and clinical settings, an embeddable mobile and web SDK, web-progressive applications, and APIs, all with cloud-based computation that power disease-specific speech tasks and analytics.
About Aural Analytics, Inc.
Aural Analytics is the industry’s leading speech neuroscience company building the world’s most advanced clinical-grade speech analytics platform for health applications across the lifespan. Its suite of mobile-first, patient-centric applications, available in up to 30 languages across Android, iOS and the web are easy to use, secure, and provide robust, clinically relevant, interpretable and validated metrics reflecting the neurological and respiratory health of its users. The company is founded on nearly three decades of NIH and NSF-funded research in speech neuroscience, is backed by dozens of high-caliber scientific publications, and has won several awards for its work in the field, including the prestigious Global SCRIP Award for Best Technology Development in Clinical Trials. Aural Analytics is based in Scottsdale, AZ. For more information, please visit auralanalytics.com or follow Aural Analytics on Twitter, LinkedIn, Medium and Facebook.
About Target ALS
Target ALS is a 501(c)(3) medical research foundation committed to the search for effective treatments for Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease. We envision a world in which no one dies of ALS and play a unique role in the battle against this disease. Founded in 2013 by former New York City deputy mayor Dan Doctoroff – who lost both his father and uncle to ALS – our approach is breaking down barriers and silos that previously inhibited research results. We do this through our Target ALS Innovation Ecosystem, which facilitates unparalleled collaboration between researchers from academia and the pharma/biotech industry. The Target ALS Innovation Ecosystem has revolutionized the field in just seven years through collaborations that have resulted in the first potential treatments since ALS was identified in 1869.
To date, the Target ALS Innovation Ecosystem, which launched in 2013 and set the groundwork for the new Target ALS Diagnosis Initiative, has yielded 175+ research projects, 12+ therapeutic targets and five clinical trials, to date.
About The Target ALS Diagnosis Initiative
Target ALS launched the first-ever comprehensive effort to discover ALS biomarkers — The Target ALS Diagnosis Initiative — through which the organization will invest $15 million in collaborative grantmaking and the development of new scientific resources. The initiative was developed in response to input from over 100 scientists, patients, caregivers and other thought leaders. They universally identified ALS biomarkers as a critical unmet need to diagnose the disease early, track its progression and provide reliable measures for new treatments.
The Target ALS Diagnosis Initiative strategically focuses on three promising areas:
- Establishing new ALS biomarker-focused collaborative funding opportunities to fuel new projects for discovery and development of ALS biomarkers.
- Creating a five-year natural history study that will integrate longitudinal biofluid collection, clinical-grade speech, language and respiratory measures, clinical and demographic information, as well as genomic datasets from ALS and control cases.
- Developing an integrated Biofluid and Genomics core that will exponentially improve the impact of human biosamples on research through the integration of longitudinal biofluids, genomic datasets and postmortem tissue with expedited, no-strings-attached access to samples worldwide.