Immunovant, Inc. IMVT announced positive top-line data from the phase IIa study — ASCEND MG — evaluating subcutaneous (“SC”) administration of its sole pipeline candidate, IMVT-1401, in patients with myasthenia gravis (“MG”), a rare neurological autoimmune disorder. Data from the study showed that the candidate met the primary endpoint. The company plans to initiate a pivotal phase III study on IMVT-1401 as a treatment for MG patients to the FDA in the first half of 2021.
Shares of Immunovant increased 3.5% on Aug 25, following the study data announcement. Shares of the company have surged 103.9% so far this year compared with the industry’s increase of 0.1%.
The mid-stage study evaluated two weekly doses — 340mg and 680mg — of IMVT-1401, an anti-FcRn antibody candidate. Data from a pre-specified analysis after six weeks of treatment showed that patients treated IMVT-1401 achieved a mean 3.8-point improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, compared to a mean decline of 0.6 points for placebo. Moreover, the candidate achieved an improvement of 8 points on Myasthenia Gravis Composite (“MGC”) scale versus a mean decline of 1.4 for placebo. Improvement on both scales by the candidate was considered statistically significant compared to placebo.
The percentage of patients showing an improvement of more than 2-points and 6-points on the MG-ADL scale were 60% and 40%, respectively, for the candidate. A more than 2-points improvement on the same scale was achieved by 20% of patients receiving placebo while no patients receiving placebo achieved a 6-points improvement. Similarly, 40% patients on IMVT-1401 achieved more than 10 points improvement on MGC scale versus none for placebo. Mean reductions in total serum IgG from baseline for the 340 mg and 680 mg doses of the candidate were 59% and 76%, respectively.
Immunovant plans to meet with the FDA to discuss the design of the phase III registrational program for IMVT-1401 in MG later this year.
Apart from MG, the company is developing the candidate in patients with thyroid eye disease and warm autoimmune hemolytic anemia.
Please note that, Alexion’s ALXN Soliris is already approved for treating generalized MG. argenx ARGX is planning to file a biologics license application, seeking approval for its pipeline candidate, efgartigimod, as a treatment for MG patients to the FDA by the end of 2020. Meanwhile, Momenta Pharmaceuticals MNTA is developing its pipeline candidate, nipocalimab, for MG in a phase II study. Immunovant’s IMVT-1401 will likely compete with these approved or under-development MG drugs going forward. However, SC administration of IMVT-1401 may prove beneficial as other candidates/drugs are available with more invasive administration options.
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