Roivant has announced top-line results from the first period of a proof-of-concept clinical study evaluating IMVT-1402, a monoclonal antibody also known as imeroprubart, to treat cutaneous lupus erythematosus (CLE).
The randomised, double-blind, placebo-controlled trial, conducted by Immunovant, a majority-owned subsidiary of Roivant, did not meet its primary endpoint.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The main outcome assessed the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score after 12 weeks of treatment.
This study enrolled 57 adult patients with CLE, who were assigned to receive either IMVT-1402 or a placebo.
While the data did not reach statistical significance on the primary measure, Immunovant observed numerical trends across several endpoints that favoured IMVT-1402 over placebo.
According to the company, patients displaying more substantial reductions in immunoglobulin G (IgG) from baseline were reportedly more likely to achieve improved clinical responses.
However, following a review of the competitive landscape and these clinical findings, Immunovant has decided to stop developing IMVT-1402 in CLE.
The company has confirmed its intention to focus on advancing IMVT-1402 in other autoimmune diseases.
Ongoing areas of development include chronic inflammatory demyelinating polyneuropathy, difficult-to-treat rheumatoid arthritis, Graves’ disease, myasthenia gravis, and Sjogren’s disease.
Immunovant CEO Eric Venker said: “On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care.
“Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward.”
Roivant’s pipeline also includes Lisraya (brepocitinib), an inhibitor for several autoimmune indications, and mosliciguat, in development for pulmonary hypertension associated with interstitial lung disease.
Roivant develops and commercialises medicines through subsidiaries such as Immunovant.
In April 2024, Roivant and Priovant Therapeutics announced positive outcomes from the Phase II NEPTUNE clinical trial of brepocitinib in non-anterior non-infectious uveitis (NIU).
