Denali Therapeutics’ ALS drug fails in mid-to-late stage trial

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(Reuters) -Denali Therapeutics said on Monday its experimental drug failed to meet the main goal of a mid-to-late stage trial involving patients with amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease.

Shares of the drug developer were down 8.2% in extended trade following the announcement.

The study’s main goal was to demonstrate a change in disease severity over time and increase survival, comparing DNL343 to a placebo, as measured by a specific scale.

In total, 186 patients received the DNL343 treatment, while 139 participants were given a placebo.

The drug also failed to meet key secondary goals of statistically significant improvements in muscle strength and respiratory function, Denali said.

“We remain deeply committed to fully understanding the effects of DNL343 in ALS and will further evaluate the data before determining next steps”, said Merit Cudkowicz, the study’s principal investigator.

ALS can affect nerve cells in the brain and spinal cord that are responsible for muscle movements, leading to progressive paralysis and death. It affects around 30,000 people in the U.S. and an estimated 500,000 people worldwide, according to the company.

FDA-approved ALS treatments available in the U.S. include Mitsubishi Tanabe’s Radicava, generic drug riluzole, and Biogen’s Qalsody.

(Reporting by Puyaan Singh in Bengaluru; Editing by Tasim Zahid)