First-in-Class Hepatitis D Tx Granted Orphan Drug Status

Eiger BioPharmaceuticals announced that the Food and Drug Administration (FDA) has granted lonafarnib an Orphan Designation for the treatment of hepatitis delta virus (HDV) infection.

Lonafarnib is a first-in-class, investigational, orally active inhibitor of farnesyl transferase, an enzyme involve din modification of proteins through prenylation. It inhibits prenylation of HDV replication inside hepatic cells and blocks the ability of the virus to multiply.

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Lonafarnib was evaluated in a Phase 2a double-blinded, randomized, placebo-controlled, dose ascending trial in patients with chronic HDV infection. Lonafarnib doses of 100mg twice daily and 200mg twice daily for 28 days were studied. Results showed a significant dose-dependent decrease in HDV RAN at 100mg twice daily and 200mg twice daily vs. placebo after 28 days of treatment (0.7 log IU/mL vs. 1.6 log IU/mL vs. 0.08 log IU/mL, respectively).

Eiger Bio is enrolling more Phase 2 proof-of-concept studies.

For more information call or visit EigerBio.com.