- Eiger BioPharmaceuticals (NASDAQ:EIGR) announces that the FDA has agreed that a single registration study assessing HDV candidate lonafarnib for the treatment of patients with hepatitis D virus (HDV) infection.
- The 300-subject study, D-LIVR, will evaluate an all-oral arm of lonafarnib + ritonavir (RTV) and a combination arm of lonafarnib + RTV + pegylated interferon-alfa compared to placebo. The study will not be required to demonstrate the superiority of lonafarnib versus pegylated interferon-alfa alone. Additional information on the trial will be provided next quarter.
- The company also plans to launch a Phase 2 study assessing pegylated interferon lambda (Lambda), combined with lonafarnib and RTV, in 26 HDV-positive patients. The primary endpoint will be at least a 2 log decline in HDV RNA at end of treatment.
- Lonafarnib inhibits an enzyme called farnesyl transferase which plays a key role in the HDV life cycle.
- Lambda is a type of interferon (type III) that targets certain receptors on liver cells. It stimulates immune responses essential in fighting viral infections.
- Shares are up 3% premarket on light volume.
- Previously: Eiger Bio's HDV pegylated interferon lambda shows positive effect in mid-stage hepatitis D study; shares down 6% on reports of jaundice (Oct. 23, 2017)
- Previously: Eiger's lonafarnib shows positive effect in mid-stage hepatitis D study (April 21, 2017)
- Now read: Proteostasis Therapeutics' FDA Breakthrough Therapy Designation Gives It An Edge
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