Denali-Sanofi ALS drug fails to meet mid-stage trial goal – 02/16/2024 at 4:27 p.m.

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(Adds information and details about the trial throughout)

Drug developer Denali Therapeutics DNLI.O said Friday that its and partner Sanofi’s experimental drug SASY.PA for a fatal neurodegenerative disease failed to slow the decline of motor function in a mid-stage study .

Denali shares were down nearly 8% in morning trading.

This failure adds to the long list of obstacles encountered in developing effective treatments for amyotrophic lateral sclerosis (ALS), a disease that affects 16,000 to 32,000 people in the United States and has almost completely paralyzed British physicist Stephen Hawking, now deceased.

To date, the U.S. FDA has given traditional approval to three drugs – Japanese company Mitsubishi Tanabe’s Radicava, generic drug Riluzole and Amylyx Pharmaceuticals AMLX.O’s Relyvrio – for the treatment of ALS.

Biogen BIIB.O’s Qalsody received accelerated approval from the agency in April last year.

Denali said its drug failed to achieve the primary goal of changing the ALS Functional Rating Scale, which measures deviations from “normal” motor functioning caused by ALS.

Their ALS drug works by inhibiting the increased activity of a protein that is thought to contribute to neurodegeneration.

ALS is a rare neurological disease that can damage nerve cells in the brain and spinal cord responsible for muscle movements, leading to progressive paralysis and death.

Sanofi will, however, continue to conduct a mid-phase trial evaluating the drug in participants with multiple sclerosis, a disease of the central nervous system.

Sanofi and Denali entered into a partnership in 2018, under which Sanofi agreed to conduct trials to test therapies developed by Denali for neurological and inflammatory diseases.

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