Immunovant has decided not to seek regulatory approval for its myasthenia gravis (MG) therapy, batoclimab, despite the Phase III study achieving its primary endpoint of reducing disease symptoms. Instead, it will use the results to advance its alternative therapy, IMVT-1402.
The company’s Phase III trial randomised trial (NCT05403541) used the Myasthenia Gravis Activities of Daily Living (MG-ADL) score to determine the impact of weekly or bi-monthly doses of batoclimab in patients determined to be acetylcholine receptor antibody positive (AChR+) after 12-weeks.
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Investigators found a 5.6-point improvement in the dose arm receiving weekly subcutaneous injections of batoclimab, and a 4.7-point improvement in the lower dose arm. The MG-ADL system uses self-reported input from patients, ranging on a scale from 0 to 24, to determine the impact of the disease on typical daily activities such as chewing, talking, breathing or the ability to perform day-to-day tasks.
MG is a chronic immune disorder in which muscles, typically those around the eyes or face, are impacted by damage to a patient’s nervous system when their immune system comes under attack from their immune system. It is typically characterised by high levels of Immunoglobulin G (IgG). In the Phase III trial participants dosed weekly saw a 74% mean IgG reduction, whilst patients dosed bi-monthly saw a 64% reduction.
Alongside results from the Phase III MG trial, the company also released initial results from the first part of its Phase IIb study (NCT05581199) examining batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) whose disease had worsened during standard of care. Similarly, patients who responded to batoclimab therapy saw on average a more than one point improvement using the Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score.
Pete Salzmann, CEO of Immunovant, said: “We are excited to share positive results from our MG and CIDP studies. While neurologists and patients are very enthusiastic about currently approved FcRn inhibitors, they tell us that they also see a lot of potential for a next-generation FcRn inhibitor that can offer deeper and more durable responses for patients whose disease is still affecting their daily function.”
Despite positive results from both trials, the company iterated that it does not intend to seek regulatory approval for batoclimab in MG or CIDP and will instead use the data from the batoclimab studies to accelerate its programs with IMVT-1402.
Salzmann added: “Beyond the results in MG and CIDP, we believe that our core thesis – that deeper IgG reduction, at the levels achieved by high dose batoclimab and high dose IMVT-1402, leads to improved clinical outcomes – will apply to a wide range of auto-antibody mediated conditions.”
If batoclimab makes it to market, research by GlobalData’s Pharmaceutical Intelligence Centre estimates that by the end of the decade it could bring in as much as $802m in sales. Within the same timeframe IMVT-1402 is predicted to bring in $982m.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of myasthenia gravis, Amgen’s Uplizna (inebilizumab-cdon) has shown sustained efficacy in a group of generalised MG patients after 52 weeks in a Phase III trial. Meanwhile, Merck KGaA (Merck) has dosed the first subject in a Phase III trial of its oral Cladribine therapy.
