Immunovant Will Use $200M Investment to Advance IMVT-1401

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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IMVT-1401 development/ million investment

Immunovant will use a $200 million strategic investment from Roivant Sciences to advance IMVT-1401, its investigational therapy for myasthenia gravis (MG) and other autoimmune conditions.

A pivotal clinical trial testing IMVT-1401 in people with MG is expected to be launched within the next 12 months, according to the company.

“We are excited to announce this significant investment by Roivant, which will expedite our development of IMVT-1401 for a wide range of autoimmune disorders,” Pete Salzmann, MD, CEO of Immunovant, said in a press release.

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Immunovant Prepares to Launch Phase 3 Trial of IMVT-1401 in MG Patients

The company also plans to restart two Phase 2 trials — testing the investigational medication in other autoimmune diseases — over the next year. The GO trial (NCT03938545) was intended to evaluate IMVT-1401’s safety and efficacy in people with thyroid eye disease, known as TED. The other trial (NCT04253236), called ASCEND-WAIHA, was designed to investigate the therapy’s efficacy, safety and tolerability in people with warm autoimmune hemolytic anemia (WAIHA).

TED is a rare condition characterized by inflammation around the eyes and WAIHA is an autoimmune disease in which the body’s immune system wrongly launches an attack against red blood cells.

Immunovant earlier this year had paused all trials testing IMVT-1401 after discovering the experimental therapy might increase patients’ levels of low-density lipoprotein (LDL). Increased levels of LDL, a cholesterol-carrying protein sometimes called “bad cholesterol,” are tied to a higher risk of heart disease.

However, a comprehensive review of the data demonstrated that the LDL increases were reversible, with none of the patients given the therapy thus far reporting major heart-related problems. Those findings led the company to restart IMVT-1401’s clinical development.

“Over the next 12 months, we plan to initiate a pivotal trial for myasthenia gravis, resume our trials in WAIHA and TED and initiate at least two additional clinical studies, including another pivotal trial in 2022,” Salzmann said.

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IMVT-1401 is designed to lower the levels of immunoglobulin G (IgG), a type of antibody that is a major driver of MG and other autoimmune diseases.

Data from a small Phase 2a clinical trial, called ASCEND MG (NCT03863080), completed in December 2020, indicated the medication was able to safely lower IgG levels and ease symptoms in adults with moderate to severe generalized MG.

“We are incredibly excited about the prospects for IMVT-1401, and we are eager to support Immunovant through this investment,” said Matt Gline, CEO of Roivant Sciences.

“We look forward to continuing to work closely with Dr. Salzmann and the Immunovant management team to help develop IMVT-1401 to maximize benefit for patients with high levels of unmet medical need,” Gline said.

Under the terms of the deal, Roivant increases its ownership stake in Immunovant from 57.5% to 63.8%.

2021 Myasthenia Gravis Survey Results

BioNews Survey Infographic

Myasthenia Gravis News conducted a survey from Feb. 11-March 28 to gain greater insight into the characteristics of the MG community and disease management. Results of the survey have now been published. Click on the image to view the infographic, and click here to read the story.