ALS is a debilitating, life shortening disease that dramatically impacts areas of the brain critical for effective communication as well as safe eating and drinking. Treatments are on their way, with new Phase I-IV trials starting each year. The motor speech deficits presenting in ALS vary based on the rate of progression, underlying genetic variation and initial site of impairment.
Enhancing monitoring of ALS
Recent accelerated approval of Tofersen (BIIB067) for treatment of SOD1-ALS has amplified interest into drug development for ALS. Early Phase trials have shown promise for improving outcomes meaningful to patients and their communication.
Redenlab scientists are working with pharma and international consortia to strengthen evidence for tracking treatment response in ALS. They partner global key opinion leaders and hold specialist expertise in identifying communication changes caused by disease progression, and leading to reduced quality of life
Patients & carers consider speech one of the most important features of disease
The ALS Association conducted their ALS Patient-Focused Drug Development survey, a parallel effort to the U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative to explore treatment priorities for patients. Individuals with ALS and caregivers of individuals with ALS reported [in order of priority] significant symptoms of fatigue and weakness, followed by speech problems, shortness of breath, difficulty sleeping, and pain [data from 887 people with ALS, 448 caregivers of living individual with ALS, and 193 of caregivers of individual with ALS who has passed away]
Understand what clinical outcome assessments mean for your trial
Redenlab have experience in FDA Type C meetings and EMA CHMP meetings for determining suitability of clinical outcomes for efficacy trials. They appreciate COA are not all equal and study phase can determine the suitability of one outcome over another. Let Redenlab help you nagivate this challenging stage of drug development.
Leading analytics with a clinical focus
Redenlab partners with clinics and scientists at the cutting edge of ALS research.
- Establishing the importance of communication in overall disease management.
- Examining the relationship between communication and health literacy.
Use cases for communication monitoring in ALS
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Phase I & II markers of brain health
