Immunovant Provides Corporate Updates and Reports Financial Results for the Quarter and Fiscal Year Ended March 31, 2021
•Immunovant plans to resume clinical development of IMVT-1401 in Myasthenia Gravis (MG) and Warm Autoimmune Hemolytic Anemia (WAIHA) as well as initiate two additional mid-to-late stage studies in the next year
•Program-wide data review suggests that IMVT-1401 has a broader therapeutic window than previously anticipated and that lipid elevations are predictable, manageable, and appear to be driven by reductions in albumin
•Cash balance of approximately $400 million as of March 31, 2021
NEW YORK, June 1, 2021 (GLOBE NEWSWIRE) – Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today provided a corporate update and reported financial results for its fiscal fourth quarter and fiscal year ended March 31, 2021.
“Following a program-wide data review, we remain confident in our plan to develop IMVT-1401 across a broad range of autoimmune indications. We look forward to constructive dialogue with regulatory agencies and plan to resume clinical development of IMVT-1401, including in a potentially pivotal trial in Myasthenia Gravis and in a phase two study of Warm Autoimmune Hemolytic Anemia in late 2021 or early 2022. We also plan to initiate two additional studies in the next twelve months after discussions with regulators.” said Pete Salzmann, M.D., Chief Executive Officer of Immunovant.
In a program-wide review, the company observed increases in LDL in multiple studies that were consistent, dose-related, and appear to be driven by reductions in albumin levels. No relationship to levels of thyroid hormone was observed. The increases in LDL and reductions in albumin were reversible upon cessation of dosing, and no major adverse cardiovascular events have been reported to date. Consultations with expert medical advisors have reinforced the company’s belief that Immunovant will be able to manage these changes within its development program via monitoring and management criteria, adjustments to dosing, and individualized anti-lipid therapy as appropriate.
Dr. Salzmann noted: “While both the 340mg and 680mg weekly doses demonstrated substantial reductions in IgG, the 255mg dose also achieved significant IgG reductions but without the same extent of undesired reductions in albumin or related increases in LDL.” IgG reductions in the Thyroid Eye Disease (TED) study ranged from 62% in 255mg to 80% in the 680mg arm. Dr. Salzmann continued: “These results present an opportunity for flexibility in dosing, dose intervals, and a lower-volume injection to explore in our future clinical trials.” Further, the company noted that in a post-hoc analysis of all patients who entered trials of IMVT-1401 on statins, only minimal LDL increases were seen across a variety of doses and indications.
Pending agreement from regulatory agencies, Immunovant plans to return to the clinic and initiate a pivotal MG trial in late 2021 or early 2022 as well as resume its trial in WAIHA on a similar timeframe. The company plans to initiate at least two additional clinical studies over the next 12 months, including another pivotal trial in 2022.
As part of the company’s data review, the Ph 2b TED study was unblinded and terminated prior to completion. While the trial showed clear biologic activity based on changes in IgG and pathologic
The following information was filed by Immunovant, Inc. (IMVT) on Tuesday, June 1, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.