Eiger discontinues Phase III hepatitis study due to safety concerns

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liver, viruses

Eiger discontinues Phase III hepatitis study due to safety concerns

Published: Sep 13, 2023

By Tristan Manalac

BioSpace

Eiger BioPharmaceuticals on Tuesday announced it was stopping the Phase III LIMT-2 study of its type III interferon candidate peginterferon lambda in chronic hepatitis delta due to safety concerns.

The decision follows a quarterly review by the Data Safety Monitoring Board, which detected four patients who developed hepatobiliary events leading to liver decompensation. The DSMB wrote to Eiger on Sept. 7, 2023, recommending the discontinuation of LIMT-2.

In reaction to the news, Eiger’s stocks dropped 36% in after-hours trading Tuesday.

CEO David Apelian called the discontinuation “disappointing” in a statement but added that the company is doing so “in the interest of patient safety.” Eiger will coordinate the study’s termination with the FDA and with LIMT-2’s investigators.

LIMT-2 was a randomized, open-label and parallel-arm study that enrolled 158 CHD patients. Peginterferon lamba was administered at a 180-mcg doses once-a-week for 48 weeks, with 24 weeks follow-up. The study’s primary outcome measure was virologic response, defined as hepatitis D virus RNA levels lower than the quantification limit at the 24-week follow-up.

The discontinuation of LIMT-2 comes weeks after Eiger launched an “extensive portfolio prioritization review,” during which the company decided to focus its time and resources on avexitide—its GLP-1 receptor antagonist—being developed for post-bariatric hypoglycemia and hyperinsulinism. The strategic pivot will also see Eiger continue the commercial support for Zokinvy (lonafarnib), its approved treatment for Hutchinson-Gilford progeria syndrome and processing-deficient progeroid laminopathies.

Meanwhile, Eiger will turn to “strategic partnering options” for its virology assets, including peginterferon lambda. At the time of the pipeline review, Apelian—who had just been appointed as CEO—said that the strength of data backing peginterferon lambda, as well as the company’s alignment with the FDA on a regulatory path forward, would make it “attractive to potential collaborators.”

Peginterferon lambda is a well-tolerated, well-characterized and first-in-class interferon candidate that uniquely binds to type III receptors, as opposed to type I receptors which are commonly targeted by interferon alfa. Because type III receptors are expressed mostly only in liver cells, Eiger’s candidate can stimulate the body’s immune response during viral infections, while also minimizing off-target effects.

Eiger is developing peginterferon lambda for hepatitis delta virus infection and is running the Phase II LIFT program, which is looking at a combination regimen of the candidate with lonafarnib and ritonavir.

On Tuesday, Eiger confirmed that it was sticking with its strategic decision of focusing on avexitide. However, while the company continues to look at strategic partnering options for its virology assets, it is “no longer in active discussions with potential partners for a worldwide license for peginterferon lambda.”

Source: BioSpace