SAR443820/DNL788 misses endpoint in Phase II HIMALAYA trial to treat amyotropic lateral sclerosis (ALS)
A Phase II trial for amyotrophic lateral sclerosis (ALS) therapy failed to show improvement in ALS functional rating scale
SAR443820/DNL788,from Sanofi and Denali, failed to meet its primary endpoint in the Phase II HIMALAYA trial. The therapy could not demonstrate a reduction in ALS Functional Rating Scale-Revised (ALSFRS-R), the primary endpoint of the Phase II trial (NCT05237284). ALSFRS-R is a validated tool to assess the severity of ALS and monitor a patient’s functional performance.
ALS is a rare fatal motor neuron disease. It is characterised by progressive degeneration of nerve cells in the spinal cord and brain. The disease affects 2 in 100,000 people per year, according to the US ALS Association.
Sanofi is investigating SAR443820/DNL788 as a treatment for multiple sclerosis (MS) in a Phase II trial (NCT05630547). The study has enrolled 174 participants and is expected to conclude in 2025, as per ClinicalTrials.gov.
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