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

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来源: FierceBiotech

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 COVID-19 that has now failed in a study for chronic hepatitis delta.

In a short update Tuesday afternoon, the company said the phase 3 LIMT-2 study is being discontinued based on the recommendation of the data safety monitoring board after a quarterly safety review. 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.

In connection with the discontinuation, Eiger is no longer actively seeking a worldwide licensing partner for 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 shifted toward phase 3 metabolic disease treatment avexitide, work on the chronic hepatitis delta indication had continued, albeit with limited spending. Now, Apelian said the focus is completely on avexitide, but funding will need to be found for the company’s further development activities.

"As we look toward the future for Eiger, we will continue to execute on our strategic pivot, announced on June 29 of this year, and seek the financial resources required to advance the company's development activities on avexitide in hyperinsulinemic hypoglycemia indications,” Apelian said.

Eiger remains on the hunt to find partners 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 ritonavir in a phase 3 study for chronic hepatitis delta virus.

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