Roivant: Immunovant Reports Positive Results From MG And CIDP Studies; Stocks Down In Pre-market

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(RTTNews) - Roivant Sciences Ltd. (ROIV), a biopharmaceutical company, announced Wednesday that its clinical-stage immunology unit Immunovant Inc.(IMVT) reported positive topline results from its Phase 3 study of batoclimab in MG and initial results from Period 1 of its Phase 2b study in CIDP.

In pre-market activity on the Nasdaq, Immunovant shares were losing around 11.1 percent to trade at $16.70, and Roivant Sciences shares were down 3% at $10.39.

Immunovant plans to initiate potentially registrational studies in both MG and CIDP with lead asset IMVT-1402 and has received clearance for its Investigational New Drug or IND applications for both indications, as announced earlier.

Roivant added that Immunovant at present does not intend to seek regulatory approval for batoclimab in MG or CIDP. The firm is focused on leveraging data and learnings from the batoclimab studies to inform and accelerate its programs with IMVT-1402.

Immunovant will wait to make a final decision about regulatory submissions for batoclimab until the results of the ongoing Phase 3 studies of batoclimab in thyroid eye disease are available.

The Phase3 study in MG is a randomized, quadruple-blind, placebo-controlled study designed to assess the efficacy and safety of batoclimab in adults with MG. The trial in MG met primary endpoint of change from baseline in MG-ADL in acetylcholine receptor antibody positive (AChR+) participants at Week 12, with a 5.6 point improvement in the higher dose arm and a 4.7 point improvement in the lower dose arm.

Further, the Phase 2b study in CIDP is a randomized, quadruple-blind, placebo-controlled study designed to assess the efficacy and safety of batoclimab in adult participants with active CIDP.

The initial CIDP results from Period 1, following standard of care washout, demonstrate a mean improvement in the adjusted INCAT disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than 70%.

Pete Salzmann, chief executive officer of Immunovant, said, "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. Today's results show that deeper IgG reduction leads to deeper responses in MG and CIDP. 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."

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