Immunovant is preparing to launch a Phase 3 trial of its investigational candidate IMVT-1401 in patients with myasthenia gravis (MG); it may lead to the treatment’s approval for this indication, pending positive results.
The new trial will build on data from two previous studies of other drug candidates that share the same mechanism of action, and provided the proof-of-concept for the use of IMVT-1401 in MG.
“Immunovant expects to engage the FDA on the design and conduct of the pivotal program and we expect the Agency’s feedback to be an important part of the final plan,” Pete Salzmann, MD, CEO of Immunovant, said in a press release.
IMVT-1401 is a monoclonal antibody designed to bind and block the activity of the neonatal Fc receptor (FcRn), a protein that is responsible for preventing the destruction of IgG antibodies, including the harmful MG autoantibodies.
By blocking the activity of FcRn, IMVT-1401 is expected to lower the levels of auto-reactive antibodies in the blood, helping to ease MG symptoms.
In the meantime, the company is expecting to announce new data from its Phase 2a ASCEND MG trial (NCT03863080), which is investigating the safety, tolerability, and pharmacological properties of IMVT-1401 in MG patients, later this year.
ASCEND MG, which is still recruiting participants at multiple sites in the U.S. and Canada, is expected to enroll 21 MG patients.
During the study, patients are assigned randomly to receive one of two weekly doses (340 or 680 mg) of IMVT-1401, or a placebo, for six weeks. This will be followed by an optional open-label extension part, in which all participants will receive 340 mg of IMVT-1401 every two weeks, for an additional six weeks.
The launch of ASCEND MG was supported by findings from an earlier study of IMVT-1401, which showed the medication was safe — when administered intravenously and subcutaneously (under-the-skin injection) — and lowered the levels of circulating antibodies in the blood of healthy volunteers.
In addition to MG, IMVT-1401 is currently being investigated as a potential treatment for thyroid eye disease (TED), another autoimmune disorder, and warm autoimmune hemolytic anemia (WAIHA), a blood disorder in which autoantibodies cause the destruction of red blood cells.
A Phase 2b trial called ASCEND GO-2 (NCT03938545) is ongoing to continue evaluating the safety and efficacy of IMVT-1401 in TED patients. Top-line results from the study are still expected in early 2021, despite the ongoing pandemic.
Data from the high dose group of ASCEND WAIHA (NCT04253236), Immunovant’s Phase 2a trial of IMVT-1401 in WAIHA patients, also are expected before the end of the year.
“During the past three months, our very experienced clinical development team has successfully maintained open lines of communication with our sites,” said Salzmann.
“We can report that new patients enrolled in our programs during calendar Q2 did not miss any in-person clinic visits during the initial treatment period,” and that some virtual visits have replaced “in-person visits during the follow-up period after initial treatment.”
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