Immunovant Meets Primary Endpoint In Difficult-To-Treat Rheumatoid Arthritis Study
Vandana Singh 5 hours ago
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Immunovant reports positive trial results for IMVT-1402 in rheumatoid arthritis and plans FDA discussions on a registrational pathway.
Immunovant (NASDAQ:IMVT) announced on Monday positive efficacy results from a clinical trial evaluating IMVT-1402 in patients with difficult-to-treat rheumatoid arthritis (D2T RA).
The company confirmed that its 600 mg dose met the primary endpoint, clearing the way for regulatory discussions with the FDA later this year to map out the registrational path forward.
Clinical Trial Results in Hard-to-Treat Arthritis
The study began with an open-label lead-in period enrolling 170 patients who received 600 mg of IMVT-1402 for 16 weeks.
At Week 28, the 600 mg cohort achieved the primary endpoint with a 92.5% ACR20 response rate versus 75.6% for placebo (p=0.0139).
Conversely, the 300 mg cohort showed no difference from placebo, posting a 75.0% response rate (p=0.9426).
Secondary endpoints numerically favored the 600 mg dose over placebo. The least squares mean Clinical Disease Activity Index (CDAI) change reached -0.3 for the 600 mg arm versus +3.1 for placebo (p=0.1096), with a decrease indicating clinical improvement.
Simplified Disease Activity Index (SDAI) changes showed +0.1 for 600 mg compared to +3.5 for placebo (p=0.1299).
Exploratory analyses revealed ACR50 response rates of 80.0% versus 56.1% (nominal p=0.0117) and ACR70 rates of 52.5% versus 36.6% (nominal p=0.1674).
Safety Profile And Pipeline Updates
Participants tolerated IMVT-1402 well throughout Period 2. The study recorded no serious adverse events, Grade 3 or higher treatment-emergent adverse events, or discontinuations resulting from adverse events across any arm.
Addressing its broader pipeline, Immunovant noted that an evolving landscape and recent field data make advancing IMVT-1402 further in SjD unlikely beyond the ongoing, fully enrolled Phase 2 trial.
The company expects topline data from potentially registrational studies in Graves’ disease (GD) and myasthenia gravis (MG) in calendar year 2027, followed by chronic inflammatory demyelinating polyneuropathy (CIDP) topline data in calendar year 2028.
IMVT Price Action: Immunovant shares were up 11.43% at $34.02 at the time of publication on Monday, according to Benzinga Pro data.
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