IMVT-1402 moves into global testing, now recruiting adults with Sjögren’s
If trial results are positive, developer likely to seek approval of injection therapy
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A global clinical trial testing Immunovant’s injection therapy IMVT-1402 against a placebo in adults with Sjögren’s disease is now recruiting participants and remains on track to provide initial data in 2028.
That’s according to a press release from the company, a Roivant subsidiary, announcing Immunovant’s latest financial results and business updates, and its associated corporate presentation.
The Phase 2b trial (NCT06979531) is expected to enroll about 180 people, ages 18 to 74, with primary Sjögren’s. To be eligible, patients must test positive for certain self-reactive antibodies associated with Sjögren’s, among other criteria. Recruitment is ongoing at dozens of sites — there are 121 study centers worldwide — across North America, South America, and Europe.
The clinical trial, whose launch plans were announced last year, is potentially registrational, meaning that if the results are positive, they may serve as the basis for applications seeking approval of IMVT-1402 as a treatment for Sjögren’s.
An autoimmune disease, Sjögren’s characteristically affects the salivary glands and tear ducts, causing dry eyes and a dry mouth. However, the condition can also affect many other systems throughout the body, leading to a wide array of possible symptoms.
Primary Sjögren’s, also known simply as Sjögren’s, occurs when the disorder develops on its own, as opposed to secondary Sjögren’s, which develops as a complication of other health disorders.
Although the causes of Sjögren’s are not completely understood, the disease is believed to be driven in large part by self-reactive antibodies, which are immune proteins that erroneously target the body’s own healthy tissue.
Antibodies against Sjögren’s-syndrome-related antigen A (SSA), also known as anti-Ro antibodies, are commonly detected in people with Sjögren’s and used as a diagnostic criterion.
IMVT-1402 expected to be safer than earlier drug batoclimab
IMVT-1402 is designed to block the activity of the neonatal Fc receptor (FcRn), a protein that helps prevent circulating antibodies from being destroyed. By blocking FcRn, IMVT-1402 aims to reduce antibody levels, including those of the self-reactive antibodies that drive Sjögren’s.
The therapy is given via under-the-skin, or subcutaneous, injections using an autoinjector that would allow self-administration at home.
IMVT-1402 is expected to have a better safety profile than the company’s first-generation FcRn blocker, batoclimab, whose development has been discontinued, the company noted in the release.
In the ongoing Phase 2b study, Sjögren’s patients with anti-SSA/Ro antibodies, moderate to severe body-wide disease activity, and residual salivary flow will be randomly assigned to receive weekly injections of either one of two doses of IMVT-1402 (300 or 600 mg) or a placebo.
The trial’s main goal is to determine whether IMVT-1402’s first dose is significantly better than a placebo at reducing bodywide disease activity after 24 weeks, or about six months. This will be assessed using a standardized tool, the Clinical European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (clinESSDAI).
Secondary goals include changes in clinESSDAI scores with the second dose, as well as the proportion of clinESSDAI-based responders with either dose. Changes in other measures of disease activity after six months will also be assessed. Participants will be considered responders if they experience an improvement of four points or more on clinESSDAI scores from the study’s start.
Those deemed responders may continue receiving the same treatment in the study’s second half, which will also last 24 weeks. Responder rates will also be assessed at the end of this part.
IMVT-1402 is also in late-stage clinical development for myasthenia gravis and several other autoimmune diseases that are driven by self-reactive antibodies.
