Key early results coming next year in global myasthenia gravis trial
Injection therapy for mild to severe gMG now being tested in adults
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- Key early results of a global clinical trial testing an injection therapy for generalized myasthenia gravis are expected in 2027.
- The treatment candidate IMVT-1402 aims to ease the effects of gMG on activities of daily living.
- The large trial, which is still recruiting, is evaluating the safety and effectiveness of IMVT-1402 in more than 200 adults.
Top-line results — a snapshot of key early findings — from a large international clinical trial testing Immunovant’s therapy candidate IMVT-1402 in adults with generalized myasthenia gravis (gMG) are expected next year, according to the developer.
The trial, involving an estimated 231 participants at 88 locations worldwide, is testing the safety and effectiveness of the injection therapy versus a placebo.
In a press release announcing the company’s latest financial results and business updates, Immunovant, a Roivant subsidiary, said the Phase 3 trial (NCT07039916) is progressing according to planned timelines. The study is still enrolling adults with mild to severe gMG at dozens of sites across the U.S., Europe, and South America.
Assuming that results are positive, Immunovant hopes to use data from the trial as a basis to apply for regulatory approval of IMVT-1402 for treating gMG.
Myasthenia gravis, known as MG, is an autoimmune disease that’s caused by self-reactive antibodies that interfere with the communication between nerve and muscle cells. This results in symptoms such as muscle weakness and fatigue. In gMG, these symptoms can affect the entire body.
IMVT-1402 designed to ease the daily effects of gMG
IMVT-1402 works by blocking the activity of neonatal Fc receptor (FcRn), a protein that helps stabilize antibodies in the bloodstream. By suppressing this protein, the therapy, administered via subcutaneous, or under-the-skin, injections, aims to reduce levels of certain antibodies, including the ones that drive MG.
The therapy’s mechanism of action is similar to the approved MG treatments Vyvgart (efgartigimod) and Rystiggo (rozanolixizumab).
Immunovant’s older FcRn-suppressing therapy candidate, batoclimab, was shown to outperform a placebo at easing gMG symptoms in a Phase 3 Flex study (NCT05403541). However, the company decided not to seek approval for batoclimab and instead to focus its efforts on IMVT-1402. The newer treatment was expected to work in the same way but with a better safety profile.
To be eligible for the ongoing IMVT-1402 Phase 3 trial, gMG patients must have a score of at least six on the MG Activities of Daily Living (MG-ADL) scale. This scale measures how much MG affects day-to-day activities; a score of six or higher indicates the disease is causing notable issues on a daily basis.
Participants are receiving weekly injections with either one of two doses of IMVT-1402 or a placebo, for 12 weeks, or about three months. The study’s main goal is to see if the experimental treatment can reduce MG-ADL scores, reflecting less severe disease, in patients who are positive for known MG-causing antibodies.
Secondary goals are the proportion of antibody-positive participants achieving a MG-ALD score of zero or one, reflecting little to no disease impact on daily life activities, as well as of those with a score reduction of at least 50%. Changes in the Quantitative Myasthenia Gravis Score, which measures muscle weakness, will also be assessed in participants testing positive for known MG-driving antibodies.
After this first 12-week treatment period, participants will receive their assigned treatment or placebo for 14 weeks (period two) and then again for about a year (period three).
The study is expected to end in late 2028.
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