Clene's ALS drug shows reduction in disease indicator levels in trial

[June 16, 2023]  (Reuters) - Clene said on Thursday its experimental amyotrophic lateral sclerosis (ALS) drug showed reduction in levels of an indicator believed to be tied with the disease progression in a mid-stage trial.

The company said its drug showed a statistically significant reduction in levels of neurofilament protein when compared to a placebo after 24 weeks of treatment.

Neurofilament protein is a marker of nerve cell degeneration. Higher levels of the protein are considered as a predictor of a more rapid decline in clinical function and greater risk of death in patients.

In April, the U.S. Food and Drug Administration granted accelerated approval for Biogen's ALS drug based on data that showed it reduced the protein levels.

Biogen would still be required to provide more data on the drug's effectiveness for it to remain on the market and for the FDA to grant traditional approval.

Clene said on Thursday it was exploring the possibility for filing a marketing application for the drug with the U.S. health regulator.

ALS, also known as Lou Gehrig's disease, is a rare neurological disease that can break down nerve cells in the brain and spinal cord that make muscles work, leading to progressive paralysis and death.

Around 16,000 to 32,000 people have ALS in the U.S., according to government data.

(Reporting by Raghav Mahobe in Bengaluru; Editing by Krishna Chandra ELuri)

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.