Clene's ALS drug shows reduction in disease indicator levels in trial
Send a link to a friend
[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.
![](http://archives.lincolndailynews.com/2023/Jun/16/images/ads/current/ldn_sda_NILA_012823.png)
[to top of second column]
|
![](http://archives.lincolndailynews.com/2019/Sep/05/images/ads/current/stclara_lda_SPONSOR_090519.png) 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reserved.]This material may not be published,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. |