Eiger BioPharmaceuticals, Inc. (EIGR), a commercial-stage biopharmaceutical company focused on rare metabolic diseases, Wednesday said it has decided to discontinue the Phase 3 LIMT-2 study of peginterferon lambda in patients with chronic hepatitis delta or CHD.
In pre-market activity on Nasdaq, Eiger shares were losing around 36 percent.
David Apelian, CEO of Eiger, said the company will continue to execute on its strategic pivot, announced on June 29, 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," he added.
The company's decision is based on the recommendation of the Data Safety Monitoring Board or DSMB for the study following its quarterly safety review.
Last week, the DSMB recommended the discontinuation of the LIMT-2 study due to observations of four patients with hepatobiliary events that resulted in liver decompensation.
The Phase 3 LIMT-2 study is an open-label, parallel-arm clinical trial that randomized patients with well-compensated CHD infection to one of two treatment groups. These are 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.
In July, the trial completed enrollment of 158 patients in 12 countries across 48 investigator sites.
Apelian said the company will work closely with FDA and its investigators to conduct an orderly termination of the LIMT-2 study in the interest of patient safety.
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