Safety Concerns Force Eiger to Halt Phase III Hepatitis Study

Eiger Halts Phase III Hepatitis Study Amid Safety Concerns, Sending Stocks Tumbling

Eiger BioPharmaceuticals dropped a bombshell on Tuesday, announcing the abrupt discontinuation of its Phase III LIMT-2 study for peginterferon lambda, a type III interferon candidate for chronic hepatitis delta. The startling decision came following a quarterly review by the Data Safety Monitoring Board, which flagged four patients experiencing hepatobiliary events leading to liver decompensation.

In the wake of this announcement, Eiger’s stocks took a nosedive, plummeting by 36% in after-hours trading on Tuesday. CEO David Apelian expressed his disappointment but underlined the company’s unwavering commitment to patient safety. Eiger will work closely with the FDA and LIMT-2’s investigators to ensure a smooth termination of the study.

LIMT-2 was a randomized, open-label, parallel-arm study with 158 chronic hepatitis delta patients. It involved administering peginterferon lambda at 180-mcg doses once a week for 48 weeks, followed by a 24-week follow-up. The study’s primary focus was on achieving a virologic response, defined as hepatitis D virus RNA levels falling below quantification limits at the 24-week follow-up.

This development comes on the heels of Eiger’s recent decision to streamline its portfolio and concentrate resources on avexitide, its GLP-1 receptor antagonist designed for post-bariatric hypoglycemia and hyperinsulinism. Additionally, Eiger remains committed to supporting Zokinvy (lonafarnib), its approved treatment for Hutchinson-Gilford progeria syndrome and processing-deficient progeroid laminopathies.

While Eiger presses forward with avexitide, the company is actively exploring strategic partnership opportunities for its virology assets, including peginterferon lambda. The company’s confidence in the strength of peginterferon lambda’s data and alignment with the FDA’s regulatory pathway makes it an attractive prospect for potential collaborators.

Peginterferon lambda stands out as a well-tolerated, well-characterized, and first-of-its-kind interferon candidate that uniquely targets type III receptors, primarily found in liver cells. This selective approach enhances the body’s immune response during viral infections while minimizing off-target effects.

Eiger’s focus remains on peginterferon lambda for hepatitis delta virus infection, with the ongoing Phase II LIFT program evaluating a combination regimen with lonafarnib and ritonavir.

As of now, Eiger’s strategic direction is firmly centered on avexitide, with the company no longer actively engaged in discussions for a worldwide license of peginterferon lambda.

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