JPM23: Roivant CEO says 2023 shaping up to be 'single most exciting year' for new readouts

Much has been said about the tumultuousness of the biotech market in 2022 and how the industry and associated innovation will fare in the new year. Roivant Sciences CEO Matt Gline has heard the prognosticating and, at this year’s J.P. Morgan Healthcare Conference, he had a concise message on behalf of his company: We’re moving up. 

“So 2023, in my opinion, is shaping up to be probably the single most exciting year from a clinical data perspective in Roivant’s history,” Gline said at the company’s Monday presentation.

Buoying his optimism is the company’s latest phase 2 readout of RVT-3101 to treat ulcerative colitis (UC), which found that nearly a third of treated patients were in remission at 12 weeks compared to 12% on placebo. Those figures improved among a biomarker-positive population, and more patients reported having endoscopic improvement. Gline said the data were like moving forward a foot “in a game of inches.” It was also a much-needed victory after Roivant—the parent of the "vant" family of companies—laid off 12% of its staff late last year. 

Plucked from Pfizer, RVT-3101 is an anti-TL1A antibody that Gline says has best-in-class ability, challenging Prometheus, which just weeks earlier reported its own head-turning UC data. But for Gline, that’s just the tip of the iceberg.

He also highlighted the company’s Immunovant roster, batoclimab and IMVT-1402, a corporate one-two punch to treat both rare and chronic immunology diseases. Batoclimab is currently being tested for a handful of conditions including thyroid eye disease and Graves’ disease, while IMVT-1402 is in a phase 1 trial for a number of indications. Gline expects a phase 1 readout by the middle of this year, which can set up a pivotal path within six months. 

And last but not least, Roivant’s TYK2/JAK1 inhibitor brepocitinib is in two registration trials—a phase 2 study for patients with lupus and a phase 3 trial for patients with dermatomyositis. A readout of the lupus trial is expected in the second half of the year. 

It’s an enviable data waterfall that is not lost on Gline as he looks to build momentum for a company that’s constructed its reputation by turning clinical scrap metal into valuable medicine. But that reputation evidently nags at Gline, who addressed it with respect to RVT-3101, after what he felt were waves of investor concerns veiled as questions. He wanted to speak to the elephant in the room: Why would Pfizer sell a drug that has this much potential? 

In short, Gline said that Roivant has built a valuable working relationship with Pfizer, where Roivant is comfortable giving up potential market upside and Pfizer is confident the drug will get to the commercial finish line. 

“I do hope, once we report the maintenance data, that we get to the bottom of the stack of turtles and there's nothing beneath it,” he said. “Because I think it's a great drug, and I don't think there's anything in the data to suggest a problem.”