Viral Hepatitis HDV: Eiger Announces Discontinuation of Phase 3 Trial of pegIFN Lambda in HDV
On September 12th, 2023, Eiger announced the discontinuation of the Ph3 LIMT-2 trial of peginterferon lambda (pegIFNλ) in patients with Chronic Hepatitis Delta.
The decision to discontinue the Ph3 LIMT-2 trial was based on the recommendation of the Data Safety Monitoring Board (DSMB) following its quarterly safety review due to observations of four patients with hepatobiliary events that resulted in liver decompensation.
Safety concerns seen in the Ph3 LIMT-2 trial suggest potential for similar risks in the Ph2 NIH-sponsored trial of lonafarnib + pegIFNλ. Hepatobiliary events were not reported for the Ph2a LIFT-1 study which investigated 24-wks of treatment with the combination of lonafarnib + ritonavir + pegIFNλ (N=26, single arm, open-label). In this study 17/22 (77%) pts achieved >2 log decline in HDV RNA and 11/22 (50%) pts achieved BLOQ or undetectable HDV RNA.
The company reiterated its strategic pivot away from its assets in viral hepatitis as they seek the finances required to advance avexitide in Post-Bariatric Hypoglycemia (PBH) and Congenital Hyperinsulinism
Other key competitors in HDV such as VIR are not expected to launch prior to 2030