Immunovant has confirmed that its first-generation FcRn inhibitor has been scrapped, a month after the asset flunked a pair of phase 3 eye disease trials.
The company first set out plans back in 2022 to assess the therapy, called batoclimab, in two late-stage studies of patients with thyroid eye disease (TED). But Immunovant’s majority shareholder, Roivant, disclosed in early April that both trials had missed their primary endpoint of demonstrating a 2 mm or greater reduction in proptosis, a term for eye bulging.
TED is an immunoglobulin G (IgG)-mediated autoimmune condition. Last month, Roivant suggested that greater improvements in proptosis seen after the high-dose period in the studies than after the low-dose period meant the data support “the benefit of deeper IgG suppression.”
The company didn’t appear willing to write off batoclimab completely, only saying in its April statement that it intended to “review future plans for the development of batoclimab” with its Korea-based partner, HanAll, and that it would provide an update “at a future date.”
But in this morning’s first-quarter earnings release, Immunovant confirmed that the road has run out for batoclimab. The biotech also noted that discontinuing the program had resulted in paying out $39 million in related contractual costs. These helped drive up R&D expenses for the fiscal year ending March 31 to $456.7 million compared with $360.9 million for the previous-year period.
Immunovant tried not to paint batoclimab as a totally wasted effort. Instead, the company said that learnings from the program, including its “clinical data, operational trial experience and relationships with investigators” could be “leveraged to inform the development” of its second-generation FcRn blocker, IMVT-1402.
Topline data from a proof-of-concept trial of IMVT-1402 in cutaneous lupus erythematosus are expected in the second half of this year, while a readout for a phase 2b study in Graves’ disease is penciled in for next year and a study in difficult-to-treat rheumatoid arthritis (RA) is also ongoing.
The company offered a slice of preliminary data from the RA study this morning, which showed that 72.7% of the study’s 170 heavily pre-treated patients had seen at least a 20% improvement in symptoms at Week 16, with 54.5% seeing a 50% or greater improvement. Investors appeared enthused by the findings, sending Immunovant’s stock up 20% to $31.71 in pre-market trading Wednesday from a Tuesday closing price of $26.29.
With $902.1 million in the bank, Immunovant said it has enough cash to continue to explore each of these indications up to a hoped-for commercial launch of IMVT-1402 in Graves’ disease.
Still, scrapping batoclimab is another blow to attempts to get an FcRn inhibitor approved for TED after argenx discontinued studies of Vyvgart for the eye condition after they appeared set to miss their goals. The writing had been on the wall for batoclimab for a while, with Immunovant having written off any chances of pursuing the drug to treat myasthenia gravis despite the drug notching a phase 3 win for the IgG-driven disorder.
