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Eiger ends hepatitis med's journey after liver damage reported, hunts for cash

2023-09-13

临床3期上市批准引进/卖出

Eiger BioPharmaceuticals CEO David Apelian, M.D., Ph.D., called the discontinuation “disappointing” and pledged to work with FDA regulators toward an early termination.

Eiger BioPharmaceuticals is finally putting a pin in efforts to find a home for peginterferon lambda, a drug once tried in COFDA-19 that has now failed in a study for chronic hepatitis delta.

Eiger BioPharmaceuticalsy afternoon, the company said the phase 3 LIMT-2 study ipeginterferon lambda based on the recommendCOVID-19 the data safety monitoring board afchronic hepatitis deltareview. The board recommended the trial be ended after four patients experienced hepatobiliary events that resulted in liver decompensation.

Eiger CEO David Apelian, M.D., Ph.D., called the discontinuation “disappointing” and pledged to work with FDA regulators toward an early termination “in the interest of patient safety.” The open-label study just completed enrollment of 158 patients in 12 countries in July.

Eigernnection with the discontinuation, Eiger is no longer actively seeking a worldwide licensing partner FDA peginterferon lambda. In June, Eiger pledged to find companies to work with on their virology assets, which included lonafarnib, too. But now, “Eiger is no longer in active discussions with potential partners for a worldwide license for peginterferon lambda,” Apelian said Tuesday afternoon.

While Eiger’s priorities had already shiEigertoward phase 3 metabolic disease treatment avexitide, work on thepeginterferon lambdaelta indicaEigerhad continued, albeit with limited spending. Now, Apelian said the focus is compllonafarnibvexitide, but funEigerwill need to be found for the company’s further development activities.peginterferon lambda Apelian

"As we look toward the future for Eiger, we will continue tometabolic diseasetrategic piavexitideunced on June chronic hepatitis deltaek the financial resources required to advance the company's dApelianent activities on avexitide in hyavexitidenemic hypoglycemia indications,” Apelian said.

Eiger remains on the hunt to find Eigerers for its remaining virology asset lonafarnib, marketed as Zokinvy. The therapy, which is FDA approved for Hutchinson-Gilford progeria syndrome, has since been tested with ritonaviavexitidease 3 study for chronic hepatitis delta virus.Apelian

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