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FDA on board with design of pivotal study for Eiger's pegylated interferon-alfa; shares up 5%

Published 09/24/2018, 01:06 PM
Updated 09/24/2018, 01:06 PM
© Reuters.  FDA on board with design of pivotal study for Eiger's pegylated interferon-alfa; shares up 5%

© Reuters. FDA on board with design of pivotal study for Eiger's pegylated interferon-alfa; shares up 5%

  • Thinly traded micro cap Eiger BioPharmaceuticals (EIGR +5%) in up on average volume of 62K shares on the heels of its announcement that the FDA agrees with its design for a pivotal Phase 3 study, D-LIVR, that will support accelerated approval for two lonafarnib-based, ritonavir-boosted regimens to treat hepatitis delta virus (HDV) infection.
  • The study will include an all-oral arm of lonafarnib (AbbVie (NYSE:ABBV)'s Norvir) boosted with ritonavir and a combination arm of lonafarnib with ritonavir combined with Eiger's pegylated interferon-alfa, both compared to placebo. Another arm with pegylated interferon-alfa alone will be used to demonstrate contribution of effect only.
  • The co-primary endpoints will be at least a 2 log(10) decline (100-fold reduction) in HDV RNA and normalization of a biomarker for liver disease called alanine aminotransferase (ALT) at week 48.
  • Previously: Enrollment underway in Eiger's mid-stage study of pegylated interferon lambda in HDV (Aug. 6)
  • Now read: Osmotica Pharmaceuticals Files To Raise Capital In U.S. IPO


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