Roivant's FcRn inhibitor avoids cholesterol problem, which clouded CEO Matt Gline's first days in the gig

Roivant CEO Matt Gline learned just days into his new gig in 2021 that immunology offshoot Immunovant had a cholesterol problem with its lead asset. Now, the concern that sent him immediately spiraling into "crisis management mode" has come full circle, as a next-gen candidate nailed key biomarker figures in a phase 1 trial. 

The new data reported Tuesday may be early and just in healthy adults but Gline feels “fantastic” that the company’s FcRn inhibitor posted reductions in immunoglobulin G without significant increases in cholesterol levels or decreases in albumin levels, a potential sign of liver disease. It's early evidence that IMVT-1402 may serve as a more formidable autoimmune treatment than batoclimab, Immunovant’s lead asset that's been dogged by cholesterol concerns. 

headshot of Roivant CEO Matt Gline
Matt Gline (Roivant)

“From five days into my new job, or a week into my new job, I was effectively in crisis management mode on this issue,” he said in an interview with Fierce Biotech. “It just feels like a very satisfying bookend on the first chapter here.” When asked how he felt when he woke up this morning, Gline succinctly said, “fantastic.” 

There was one discontinuation among the group of healthy patients given the subcutaneous treatment though it was due to a mild side effect unrelated to the study drug. 

Batoclimab will not just fade into the rearview, however. Gline said that FcRn as a target has shown broad applicability and that “the world is only going to be well served by having more of these programs.” He suggested that the therapy may be used in more acute settings where rising LDL-C levels are less consequential whereas IMVT-1402 could have broader applicability, though he cautioned that no decisions have been made yet. 

On a call with investors, Immunovant CEO Peter Salzmann, Ph.D., indicated that Grave’s disease would be atop the list of indications for IMVT-1402, should a phase 1 readout from batoclimab be positive later this year. Similarly, he said the company is “trending towards” a registrational program in chronic inflammatory demyelinating polyneuropathy (CIDP) with IMVT-1402, another indication where batoclimab is being tested. 

“How we can make [the CIDP] package most efficient by taking advantage of batoclimab, we have a lot of different ideas there,” he said. 

He also noted Johnson & Johnson's nipocalimab, also a FcRn inhibitor, which read out earlier this year in patients with rheumatoid arthritis as an emerging indication.

Salzmann didn’t widely expand on how Immunovant will finance a potentially large and growing clinical program beyond saying that the company plans to raise equity in the capital markets to develop the first indications themselves. 

And that equity just got a lot more valuable, with the company’s shares up 75% shortly after the market opened on Tuesday, from $20.28 to $35.66. Researchers at Leerink wrote that the data appeared to “meet/exceed expectations” and reaffirmed that such data could skyrocket Immunovant toward a $5 billion valuation.