Eiger shared topline results for lonafarnib from the Ph3 D-LIVR study

Eiger hosted a conference call and shared a press release detailing the topline data from the D-LIVR study (N=407) which included primary and key secondary endpoints.

 Key takeaways

• Despite achieving statistical significance against placebo in composite primary endpoint for both the “all oral” (LNF+ RTV) and “combo” (LNF + RTV + Peg IFNα), response rates reported were weak at 10.1% and 19.2% respectively
• Despite caveats of cross-trial comparison efficacy on the same endpoint was notably lower than bulevirtide’s (45% response rate)
• In this study, the LNF regimens demonstrated similar (in some cases weaker) efficacy and safety endpoints as Peg IFNα monotherapy arm; Effects of the LNF regimens seem to wane mid-study
• The most positive aspect of the data presented was the biopsy data; “Combo” (LNF + RTV + Peg IFNα) regimen showed significant histological improvement at 48 weeks, but the “all oral” regimen showed no effect
• As expected, GI AEs were the most common AEs. Surprisingly, the treatment discontinuation rate was similar between LNF regimens and placebo at ~18%; drug discontinuations due to LNF was 8-9% vs 2% for placebo; 33% of LNF patients required dose reductions
• Eiger executives definitively stated that regulatory submissions will include 24-wk post-tx data expected mid-2023; thus, filing will be delayed to mid-2023 and soonest possible approval is 2Q 2024
• Eiger believes off-drug data may provide more clarity on the possibility of response-guided treatment approaches, with the potential for finite therapy in durable responders vs. chronic intermittent therapy

• We anticipate that Eiger would have to conduct a new long-term study to demonstrate that LNF regimens are safe and efficacious as an “intermittently chronic” therapy, eg, patients who are ineligible for Peg IFNα. In this scenario approval could possibly be achieved in 2025 or beyond
• In the unlikely scenario that LNF regimens receive an approval, Eiger is likely to face reimbursement challenges due to the LNF regimens having similar (in some cases weaker) efficacy and safety endpoints as Peg IFNα. The discontinuation rates, lower medication adherence / treatment interruption increases the level of uncertainty about the clinical effectiveness of the treatment.
• Eiger stock was down more than 75% on the news, suggesting investor disappointment

Sources:

Eiger Corporate Deck

D-LIVR Topline Data Investor Call Slides