Eiger BioPharmaceuticals said it is discontinuing the company's phase 3 study to treat peginterferon lambda in patients with chronic hepatitis delta and has ceased active discussions for a worldwide license of the treatment.
The commercial-stage biopharmaceutical company said its decision is based on the Data Safety Monitoring Board, which recommended the discontinuation following a quarterly safety review.
Four patients with hepatobiliary events resulted in liver decompensation during the LIMT-2 study, the company said.
"We will work closely with the Food and Drug Administration and our investigators to conduct an orderly termination of the LIMT-2 study in the interest of patient safety," Chief Executive David Apelian added.
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