After imeroprubart failed to demonstrate sufficient efficacy in lupus during a Phase 2b trial, Immunovant is moving on from the indication and looking to other high priority programs for the drug in neurology, endocrinology and rheumatology.
Immunovant’s proof-of-concept trial for IMVT-1402 has failed to meet the company’s bar for efficacy in lupus and will be discontinued, with analysts brushing off the low-priority indication. But the company still has an expansive program testing the asset across neurology, rheumatology and endocrinology.
The anti-FcRn agent, also known as imeroprubart, did not improve signs of disease activity or severity during a Phase 2b trial featuring patients with cutaneous lupus erythematosus (CLE), failing to meet the study’s primary endpoint, according to a Wednesday press release. Immunovant did note some positive trends toward efficacy, including some improvements on clinical outcomes, but the study did not reach the company’s expectations.
The Phase 2b trial featured 57 adults with CLE who received either IMVT-1402 or placebo for 12 weeks. The primary endpoint was a change in baseline on a common scale of CLE disease activity and severity at week 12. Immunovant did not provide specific results from the trial, saying only that the trial had failed and that it will no longer advance the asset in CLE.
Immunovant’s shares sagged by 5% to $35.28 after news of the failed trial was revealed.
“We believe investor expectations were relatively low for this readout,” Leerink Partners wrote on Wednesday morning. Executives from parent company Roivant previously referred to CLE as the smallest of a number of upcoming catalysts for Immunovant, Leerink pointed out.
The firm views the CLE findings as having limited readthrough to the company’s other ongoing clinical programs for IMVT-1402, pointing to best-in-class opportunities for IMVT-1402 in Graves’ disease and difficult-to-treat rheumatoid arthritis, and mid/late stage development options in myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease.
“Importantly, these CLE results do not alter our broader thesis,” Leerink stated, adding that the failed trial did validate “the clean safety profile observed to date.”
Truist Securities had a different take, writing Wednesday that “the outcome modestly increases our skepticism regarding the efficacy potential of IMVT-1402 in more complex systemic autoimmune diseases such as rheumatoid arthritis and Sjögren’s disease, where pathogenic mechanisms likely extend beyond IgG-mediated injury.”
Analysts are awaiting FDA feedback on Immunovant’s potentially registrational program for IMVT-1402 in difficult-to-treat rheumatoid arthritis. That feedback is expected sometime this year. The biotech shared positive topline results from the open-label portion of the study this spring, with management indicating that they do not expect statistically significant results from the randomized, second portion after the initial results set a high efficacy bar, according to Leerink. Regardless of statistical significance, Immunovant has implied that it plans to move the program forward after alignment with the FDA.
Beyond rheumatoid arthritis, the biotech expects potentially registrational data in both Graves’ disease and myasthenia gravis in 2027.
