Aural Analytics’ speech-based digital technology will be used to measure changes in speech in people with amyotrophic lateral sclerosis (ALS) as endpoints for the HEALEY ALS Platform Trial, which is evaluating multiple potential ALS treatments simultaneously.
Under the direction of specialists at the Healey Center for ALS at Massachusetts General Hospital, the HEALEY trial (NCT04297683) is enrolling adults with sporadic or familial ALS at 54 sites across the U.S., which are all part of the Northeast ALS (NEALS) consortium.
Speech changes in ALS patients represent an important marker of disease progression and early detection of symptoms.
Currently available in 12 languages, Aural Analytics’ speech-based endpoints have been used extensively in ALS trials — at the clinic and at home — to measure speech changes in response to treatment. The company reports that its software architecture and suite of analytics are easy-to-use, with patient-centered applications designed to support a multi-site and multi-target trial.
Additionally, its Speech Vitals mobile application is designed for patients’ ease, with the app remotely collecting and analyzing speech for researchers conducting clinical trials.
“Aural Analytics exists to be a catalyst for improving the lives of patients with neurological health issues,” said Daniel Jones, the company’s CEO, in a press release. “We are honored to be working alongside Mass General Hospital and the Sean M. Healey Center serving the ALS population.”
“We are committed to, and share the long-term goal of the platform trial,” he added.
HEALEY is expected to accelerate the development of ALS therapies by allowing more medicines to be tested, and by increasing patient access to trials. The effectiveness of multiple treatments will be evaluated simultaneously. Through shared infrastructure, common data, and sample collection processes, platform trial costs are expected to be significantly lower than those of conventional, single-therapy studies.
This trial will start by investigating patient outcomes in three potential medicines — zilucoplan by UCB, verdiperstat from Biohaven Pharmaceuticals, and Clene Nanomedicine’s CNM-Au8 — against a matching placebo. Additional investigational treatments are to be added to the trial as they become available.
Participants in HEALEY will be randomly assigned to a treatment regimen. Within each regimen, 160 patients will be randomly divided into four groups: three to receive treatment and one a placebo. Treatment will last 24 weeks.
Regimen A (NCT04436497) will investigate the subcutaneous (under-the-skin) administration of zilucoplan, a small molecule that blocks the C5 protein, which is abnormally activated in ALS patients. The medicine will be given at daily doses ranging from 0.22 to 0.42 mg/kg.
Regimen B (NCT04436510) will assess oral verdiperstat, a molecule that reaches the brain and selectively blocks the MPO enzyme, which is thought to increase inflammation and oxidative stress in the brain and spinal cord. Treated patients will be given 600 mg tablets of verdiperstat twice daily.
Regimen C (NCT04414345) will measure the impact of CNM-Au8, an oral liquid suspension of gold nanocrystals designed to improve nerve cell function and survival. Two daily doses of CNM-Au8, at 30 mg or 60 mg, will be given those in treatment arms.
Along with speech analytics, the goal of all three regimens is to measure changes in disease progression using the ALS Functional Rating Scale Revised (ALSFRS-R) score. Additional parameters include muscle strength, lung function, and survival.
Two potential treatments, Implicit Bioscience’s IC14 immunotherapy and Prilenia’s pridopidine, are expected to be added to the platform trial. These first five therapies were chosen out of 30 applications from 10 countries by a group of leading ALS researchers and the Healey Center Science Advisory Committee.
“Our shared goal is to bring new therapies forward faster for people with ALS,” said Merit Cudkowicz, MD, director of the Healey Center. “Speech analytics technology has the potential to provide important insights about the effects of treatments in the platform trial.”
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