Drug Developer 89Bio Soars as NASH Drug Succeeds in Midstage Study

(Reuters) – Drug developer 89Bio Inc said on Wednesday its experimental treatment for liver disease NASH met the main goals of a small mid-stage study, sending its shares 30% higher.

The drug, pegozafermin, helped reduce liver scarring known as fibrosis as measured on two different scales in patients with NASH, or nonalcoholic steatohepatitis, trial data showed.

NASH, which has no approved treatments, is the fastest-growing cause of liver transplants in developed countries.

Approved therapies are expected to be a multi-billion dollar market in the United States, with Novo Nordisk and other smaller companies racing to develop the drugs.

89Bio said the drug, administered both weekly and every two weeks in the trial, had a safety profile similar to older trials. The most frequent adverse events of diarrhea, nausea and increased appetite were mild to moderate, it said.

“We believe physicians and patients will value pegoza’s safety and less frequent dosing, especially in a chronic disease like NASH,” SVB Securities analyst Thomas Smith said in a note.

In the trial, the drug helped significantly reduce fibrosis or liver scarring without the worsening of NASH, compared to a placebo. It also helped decrease fibrosis by one stage, without the disease worsening.

Madrigal Pharmaceuticals in December gained a head-start in the development of a treatment as its experimental drug met the main goals in an eagerly anticipated late-stage study.

89Bio said the data supported advancement of the drug to late-stage development.

Shares of the San Francisco-headquartered company, which had a market capitalization of $572.44 million as of last close, were up 30% at $14.21 in early trading.

NASH, a form of non-alcoholic fatty liver disease, is characterized by the organ developing fibrosis or scarring, which can progress to cirrhosis and liver failure.

It is estimated to affect about 5% of adults in the United States, as per the American Liver Foundation.

(Reporting by Pratik Jain in Bengaluru; Editing by Sriraj Kalluvila)

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