Roivant stops CLE study of IMVT-1402

• Roivant (NASDAQ:ROIV) reported that Immunovant’s IMVT-1402 trial in cutaneous lupus erythematosus did not meet its primary endpoint.
• The company plans to stop development of IMVT-1402 in cutaneous lupus erythematosus after the Phase 1 proof-of-concept study results.
• Roivant said other IMVT-1402 clinical programs in autoimmune diseases remain on track.

Roivant (NASDAQ:ROIV) reported topline results from Immunovant’s proof-of-concept trial of IMVT-1402 in cutaneous lupus erythematosus, with the study failing to meet its primary endpoint.

The trial did not achieve statistical significance for the percent change from baseline in CLASI-A score at Week 12, leading Immunovant to discontinue development of IMVT-1402 in cutaneous lupus erythematosus.

Immunovant said numerical trends favored IMVT-1402 compared with placebo across multiple trial measures, and greater reductions in IgG levels were associated with stronger clinical responses.

IMVT-1402 demonstrated a safety and tolerability profile consistent with previous studies, according to the company, with no changes announced for other autoimmune disease development programs.

Roivant said Immunovant’s remaining IMVT-1402 clinical development timelines in other autoimmune indications remain on track.