Immunic's Early Cut Data From Psoriasis Candidate Failed To Show Desired Activity Signal Over Placebo

  • Immunic Inc IMUX announced the outcome of a pre-planned interim group-level data analysis of its phase 1b trial of IMU-935 in patients with moderate-to-severe psoriasis. 
  • The interim analysis revealed that the group averages for Psoriasis Area and Severity Index (PASI) reductions in the two active arms did not separate from the placebo at four weeks. 
  • Although the active arms performed in line with prior expectations, the trial experienced a greater decrease than expected in PASI in the placebo arm.
  • The company says that currently, it has access to very limited information. The interim analysis only revealed mean values at the group level up to the end of the four-week treatment period. 
  • Immunic does not yet have access to unblinded individual patient data. Moreover, pharmacodynamic biomarkers or pharmacokinetic data are not yet available at an individual or group level. 
  • Although the safety data remains blinded, IMU-935 was demonstrated to be safe and well-tolerated, and no new safety signals were observed.
  • "The unexpected high placebo rates observed in this interim analysis are disappointing and confound the activity evaluation in the investigated active treatment arms. This requires further investigation throughout the coming weeks and months," stated Andreas Muehler, Chief Medical Officer of Immunic. 
  • The company reiterates its prior guidance that the current cash balance is expected to fund expenditures into Q4 of 2024. 
  • Price Action: IMUX shares are down 69.13% at $2.84 during the premarket session on the last check Friday.
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