The discontinuation of LIMT-2 was announced after 4 patients experienced hepatobiliary events resulting in liver decompensation during the phase 3 study of peginterferon lambda for HDV.
Eiger BioPharmaceuticals announced the discontinuation of LIMT-2, a phase 3 study of peginterferon lambda in patients with chronic hepatitis delta, due to safety concerns.
Announced on September 12, 2023, the decision was based on the recommendation of the Data Safety Monitoring Board (DSMB) after a quarterly safety review revealed 4 patients experienced hepatobiliary events resulting in liver decompensation. The DSMB wrote to Eiger on September 7, 2023 suggesting discontinuation based on the safety concerns.1
"The study discontinuation is disappointing, especially for patients with chronic hepatitis delta who have limited treatment options," said David Apelian, MD, PhD, CEO of Eiger.1 "We will work closely with FDA and our investigators to conduct an orderly termination of the LIMT-2 study in the interest of patient safety."
In a June 29, 2023 release, Eiger announced a decision to focus on the advancement of avexitide in hyperinsulinemic hypoglycemia indications following a portfolio prioritization review. Of note, the company indicated it was evaluating strategic partnering options for lonafarnib and peginterferon lambda.2
"For our other late-stage assets, lonafarnib and peginterferon lambda, we believe the strength of our data and alignment on a regulatory path with FDA make them attractive to potential collaborators. We are actively engaged in discussions with potential partners,” said Apelian.2
Peginterferon lambda is a late-stage type III interferon (IFN) that stimulates critical immune responses for the development of host protection during viral infections by targeting type III IFN receptors. It is an investigational agent not yet approved for any indication. Eiger developed peginterferon lambda as a monotherapy and in combination with Lonafarnib boosted with ritonavir to treat and cure hepatitis delta virus (HDV).3
On December 21, 2021, Eiger announced the first patient enrollment in LIMT-2, an open-label, parallel-arm phase 3 clinical trial. In July 2023, 158 patients in 12 countries across 48 investigator sites were enrolled. Patients with chronic HDV were randomized to 1 of 2 treatment groups: peginterferon lambda 180 mcg QW for 48 weeks with 24 weeks follow-up, or no treatment for 12 weeks followed by peginterferon lambda treatment for 48 weeks with 24 weeks of follow-up.1,3
All patients received tenofovir or entecavir throughout the study duration. Primary analysis sought to compare the proportion of patients with a Durable Virologic Response (DVR) in the peginterferon lambda treatment group to the proportion of patients with HDV RNA BLQ after 12 weeks of no treatment in the comparator group.3
"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. We continue to evaluate strategic partnering options for our virology assets. Eiger is no longer in active discussions with potential partners for a worldwide license for peginterferon lambda," said Apelian.1