HanAll Biopharma: "Imeropruvat Demonstrates Efficacy in Difficult-to-Treat Rheumatoid Arthritis"

ACR20 response rate of 92.5% at Week 28
Statistically significant vs. placebo
Plans to discuss next steps in development with FDA by year-end

Immunovant, the global partner of HanAll Biopharma, announced on Nov. 10 that it had met the primary endpoint in a clinical trial of imeropruvat (IMVT-1402) in patients with difficult-to-treat rheumatoid arthritis (D2T RA), according to its quarterly earnings announcement on Nov. 9 local time.

The trial enrolled patients with “highly refractory arthritis” whose symptoms had not improved despite treatment with at least two different targeted therapies with distinct mechanisms of action. In Part 1, patients received a high dose of imeropruvat (600 mg) for 16 weeks. In Part 2, patients who responded were randomly assigned to receive a high dose (600 mg), a low dose (300 mg), or a placebo for an additional 12 weeks.

In Part 2, the high-dose imeropruvat group had a response rate of 92.5% on the primary endpoint, ACR20 at Week 28, statistically significantly higher than the 75.6% rate in the placebo group (p=0.0139). The high-dose group also showed increases in the exploratory endpoints, with ACR50 and ACR70 response rates reaching 80% and 52.5%, respectively, at Week 28.

Among patients whose symptoms had not improved sufficiently despite treatment with both JAK inhibitors and TNF inhibitors, ACR20, ACR50, and ACR70 response rates at Week 28 were 92%, 76%, and 56%, respectively, showing a treatment response consistent with that of the overall patient population.

However, no statistically significant differences were found in the secondary endpoints measuring disease activity: the Clinical Disease Activity Index (CDAI) and the Simplified Disease Activity Index (SDAI). No serious adverse events or discontinuations due to adverse events were reported.

Immunovant plans to discuss its next steps for developing imeropruvat for approval in difficult-to-treat rheumatoid arthritis with the U.S. Food and Drug Administration (FDA) by the end of this year.

Meanwhile, topline results for imeropruvat in other indications, Graves’ disease (GD) and myasthenia gravis (MG), are expected in 2027, while results from the clinical trial for chronic inflammatory demyelinating polyneuropathy (CIDP) are expected in 2028.

For Sjögren’s disease (SjD), the company does not expect to pursue further development after the ongoing Phase 2 trial, in consideration of the current market environment and competitive landscape.

This content was produced with the assistance of AI translation services.