The decision to discontinue the trial was based on the recommendation of the Data Safety Monitoring Board (DSMB) for the study following its quarterly safety review
Eiger to stop Phase 3 trial of Peginterferon Lambda. (Credit: valelopardo from Pixabay)
US-based Eiger BioPharmaceuticals has announced its plans to halt the Phase 3 LIMT-2 trial of peginterferon lambda in patients with chronic hepatitis delta (CHD).
Eiger is a biopharmaceutical company with a focus on rare metabolic diseases therapies development.
The decision to discontinue the trial was based on the recommendation of the Data Safety Monitoring Board (DSMB) for the study following its quarterly safety review.
In a statement, the DSMB recommended stopping the LIMT-2 study due to observations of four patients with hepatobiliary events that caused liver decompensation.
Eiger CEO David Apelian said: “The study discontinuation is disappointing, especially for patients with chronic hepatitis delta who have limited treatment options.
“We will work closely with the FDA and our investigators to conduct an orderly termination of the LIMT-2 study in the interest of patient safety.”
The Phase 3 LIMT-2 study is an open-label, parallel-arm clinical trial of patients with well-compensated CHD infection to one of two treatment groups.
It randomised patients in peginterferon lambda 180 mcg QW for 48 weeks with 24 weeks of follow-up, or no treatment for 12 weeks followed by peginterferon lambda treatment for 48 weeks with 24 weeks of follow-up.
In July this year, the study concluded the enrollment of 158 patients in 12 nations across 48 investigator sites.
Apelian added: “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.”
Eiger’s primary product candidate, avexitide, is a well-characterised, first-in-class GLP-1 antagonist for the treatment of congenital hyperinsulinism (HI) and post-bariatric hypoglycemia (PBH).
In July last year, the firm secured the European Commission (EC) authorisation for Zokinvy (lonafarnib) to treat Hutchinson-Gilford progeria syndrome (HGPS) and processing-deficient progeroid laminopathies (PL).