Eiger halts hepatitis drug development after liver toxicity, seeks funding for other programs

Eiger BioPharmaceuticals, hepatitis, lonafarnib, liver toxicity, phase 3 trial hold, pipeline, Clinical trial hold

Eiger BioPharmaceuticals has made the decision to discontinue the pursuit of a home for peginterferon lambda, a drug that was initially explored for COVID-19 treatment but has now experienced setbacks in a study for chronic hepatitis delta.

In a succinct update, Eiger revealed that the phase 3 LIMT-2 study is being terminated following a recommendation from the data safety monitoring board. This decision was prompted by a quarterly safety review that identified four patients experiencing hepatobiliary events leading to liver decompensation.

CEO of Eiger, David Apelian, M.D., Ph.D., expressed his disappointment at the discontinuation and pledged to collaborate with FDA regulators to ensure an early termination “in the interest of patient safety.” The open-label study had recently completed enrollment, comprising 158 patients across 12 countries in July.

In light of the study’s discontinuation, Eiger is no longer actively pursuing a worldwide licensing partner for peginterferon lambda. Earlier in June, Eiger had announced its intention to seek partnerships for its virology assets, which included lonafarnib. However, the company has now confirmed that it is no longer engaged in active discussions with potential partners for a worldwide license for peginterferon lambda.

While Eiger had already shifted its focus towards the phase 3 metabolic disease treatment, avexitide, it had continued work on the chronic hepatitis delta indication, albeit with reduced spending. However, the recent developments have led Apelian to underscore that the company’s primary focus is now entirely on avexitide. Securing funding for further development activities will be a priority for Eiger in this regard.

As Eiger moves forward, it remains committed to seeking partners for its remaining virology asset, lonafarnib, marketed as Zokinvy. This therapy, initially FDA-approved for Hutchinson-Gilford progeria syndrome, has undergone testing in a phase 3 study for chronic hepatitis delta virus, and Eiger is determined to find partners to continue its development journey.

Eiger’s journey in the pharmaceutical landscape continues to evolve, with a renewed focus on avexitide and a commitment to finding collaborative partners to advance its virology assets.

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