Eiger annuncia aggiornamenti sullo studio di Fase III con lonafarnib nel trattamento del HDV

Eiger updated the status of their Ph3 D-LIVR trial to “Completed” from “Active, not recruiting” and included the final enrollment number (n=407).

CI Assessment:

• The Ph3 D-LIVR study status change confirms expectations that 24-week off-treatment data will likely be released between mid-April and late May 2023
  • Based on this trial update there is a possibility that the 24-wk off-treatment data from the D-LIVR study could be presented as a late-breaker at EASL (Deadline for late-breaker submission is April 26^th. Late-breakers to be announced on May 15^th).
• Study completion keeps Eiger on-track with their plan to request a pre-NDA meeting with the FDA by end of Q2 2023 (Eiger executives previously indicated that FDA required full 72-wk data for that discussion)
  • Likelihood of approval for lonafarnib regimens seems low due to weak 48-wk on-treatment efficacy and safety data, lack of long-term safety and efficacy data, and absence of ongoing study generating longer term data to support a conditional approval
  • Despite the high unmet need in HDV and promising secondary histology EPs from Ph3 D-LIVR study, it is likely that the FDA would request Eiger to conduct an additional Ph3 study. Thus, approval prior to 2027seems highly unlikely
• It appears there have been no commercial hires to support a launch since the announcement of the D-LIVR topline data

Eiger also announced the appointment of a new Chief Financial Officer and Chief Compliance Officer, but did not provide any updates on a permanent CEO. David Apelian, MD, PhD, continues to serve as interim CEO of Eiger