Immunovant has opted not to pursue commercialization of its FcRn inhibitor batoclimab for myasthenia gravis and chronic inflammatory demyelinating polyneuropathy (CIDP), citing concerns over its impact on cholesterol levels. The biotech had previously made a second-generation molecule, IMVT-1402, its lead candidate in both indications.
A phase 3 trial of batoclimab hit its primary endpoint in myasthenia gravis, showing significant improvements on the MG-ADL symptom and activity scale, with reductions in IgG levels. However, Immunovant is now focusing on IMVT-1402, citing its potential to deliver deeper IgG suppression and longer response times.
The switch reflects concerns over batoclimab’s impact on cholesterol levels, which are linked to lower albumin levels. Immunovant has mitigated this issue with IMVT-1402, presenting the data as evidence that its next-generation candidate will outperform the competition. Analysts remain bullish on IMVT-1402, citing its potential to address the debate over whether deeper IgG suppression matters in treating myasthenia gravis and CIDP.
In a call with investors, CEO Matt Gline highlighted the benefits of IMVT-1402, stating that it will enable Immunovant to “get deeper faster” and hold responses for longer. The biotech has left the door open for batoclimab in thyroid eye disease but will make a final decision after seeing phase 3 data. Despite initial concerns from investors, some analysts were more upbeat on IMVT-1402, with one analyst praising the data as “incredible” and putting the debate over deeper IgG suppression to rest.
Source: https://www.fiercebiotech.com/biotech/immunovant-posts-phase-3-autoimmune-win-wont-seek-approval