Clene says FDA finds ALS drug data not enough for accelerated nod

[December 22, 2023]  (Reuters) -Clene said on Thursday data on its therapy to treat a type of neurological disease did not meet the U.S. drug regulator's target for accelerated approval.

Shares of the biotech company fell 35.9% to 33 cents before the bell.

The company is developing a drug to treat amyotrophic lateral sclerosis (ALS), which is a rare neurological disease that can break down nerve cells in the brain and spinal cord responsible for muscle movements, leading to progressive paralysis and death.

The U.S. Food and Drug Administration (FDA), in a meeting to discuss the regulatory path for the company's drug, determined that initial findings from mid-stage studies were not sufficient to support an accelerated nod, Clene said.

Data on the company's treatment, however, had shown the therapy led to a reduction in levels of the neurofilament protein, which is believed to be tied to the progression of the disease.

It comes in contrast with the FDA granting accelerated approval for Biogen's ALS drug in April, based on data that showed it reduced the protein levels.

Clene said it plans to provide supplemental data for further discussion with the FDA in the first half of the next year.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The company, which claims to have enough cash to run operations into the third quarter of 2024, is yet to file a marketing application for the drug.

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

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

(Reporting by Christy Santhosh; Editing by Shweta Agarwal)

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