Immunovant has stopped development of IMVT-1402 in cutaneous lupus erythematosus (CLE) after failing a midphase test, closing off one path to market for the anti-FcRn antibody.
The biotech, which is part of Roivant’s stable, compared IMVT-1402 to placebo in 57 adults with CLE. At Week 12, scores on a CLE area and severity scale were statistically no better on IMVT-1402 than on placebo, causing the trial to miss its primary endpoints.
Immunovant looked for some silver linings, flagging numerical trends favoring IMVT-1402 on multiple endpoints and evidence that patients with deeper IgG reductions from baseline were more likely to respond. But the “competitive landscape and the clinical results observed” persuaded the company to end IMVT-1402 development in CLE.
Shares in Immunovant fell 6% to $35 in premarket trading Wednesday from a Tuesday closing price of $37.29.
Guggenheim Securities analysts were braced for bad news after hearing Immunovant executives characterize the CLE trial as a “fact-finding proof-of-concept” study in a “competitive landscape.” The comments left the analysts “a bit cautious on this readout,” the team wrote in a note to investors last month.
Johnson & Johnson has shown FcRn blockers have potential in systemic lupus erythematosus, reporting a phase 2 win for Imaavy in the indication in January and powering into a pivotal program. But while J&J, argenx and others are studying anti-FcRn molecules in a range of indications, CLE is largely the preserve of drug candidates with other mechanisms of action.
In March, Biogen reported a midphase win for its anti-BDCA2 antibody litifilimab in CLE. AstraZeneca and Germany's Merck KGaA are running phase 3 CLE trials of a type I interferon receptor inhibitor and a small-molecule inhibitor of Toll-like receptors 7 and 8, respectively (TLR7/8). Meanwhile, Beeline is preparing to advance its TLR7/8 inhibitor into phase 3.
While Immunovant backed away from a fight with those programs, the biotech continues to advance its anti-FcRn antibody in other indications. Immunovant is working on Graves’ disease, rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjogren’s disease. In a positive for those efforts, IMVT-1402 had a favorable safety and tolerability profile in the CLE trial.