Eiger halts Phase III chronic hepatitis delta study, ends licensing talks
临床3期高管变更
Eiger BioPharmaceuticals announced that it is discontinuing the Phase III LIMT-2 study of peginterferon lambda in patients with chronic hepatitis delta (CHD) and has ceased active discussions for a global license of the treatment. The company said its decision is based on a recommendation from the Data Safety Monitoring Board (DSMB) to end the trial following a quarterly safety review.
"The study discontinuation is disappointing, especially for patients with chronic hepatitis delta who have limited treatment options," said David Apelian, who was appointed CEO in June, when Eiger also announced its intention to focus on metabolic diseases with the GLP-1 receptor antagonist avexitide. "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," he said.
Liver decompensation
According to the company, the DSMB earlier this month advised halting the study after four patients had hepatobiliary events that resulted in liver decompensation. In July, the trial completed enrolment of 158 patients with well-compensated CHD infection. The study randomly assigned 105 patients to peginterferon lambda 180 mcg once weekly for 48 weeks, and 53 patients to no treatment for 12 weeks followed by peginterferon lambda for 48 weeks. All participants were then to receive 24 weeks of follow-up.
Strategic pivot
Apelian stated that "we will continue to execute on our strategic pivot… and seek the financial resources required to advance the company's development activities on avexitide in hyperinsulinaemic hypoglycaemia indications." He added that Eiger continues "to evaluate strategic partnering options for our virology assets."
Eiger licensed worldwide rights to peginterferon lambda from Bristol Myers Squibb in 2016. Last year, the FDA rejected Eiger's attempt to get emergency approval for peginterferon lambda as a COVID treatment.
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